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Closed 1/21/2009 18854 CDISC
Closed 1/21/2009 18855 CDISC
Closed 1/21/2009 18856 CDISC
Closed 1/21/2009 18857 CDISC
Closed 1/22/2009 18881 CDISC
Closed 1/23/2009 18905
Closed 1/23/2009 18906 NCI
Closed 1/29/2009 19014 NCI-EVS
Date of Submission
Request Code
Submitter Name
Submitter Affiliation
Submitter E-mail
Request Type
CDISC Codelist
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-VSTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Mauron, Charlotte
Hoffmann-La Roche
Modify Existing Term
SDTM-UNIT
Quinn, Theresa
Modify Existing Term
SDTM-LBTEST, SDTM-LBTESTCD
Muhlbradt, Erin
Modify Existing Term
SDTM-TPHASE
Closed 1/29/2009 19016 NCI-EVS
Closed 1/29/2009 19017 NCI-EVS
Closed 1/29/2009 19018 NCI-EVS
Closed 1/29/2009 19019 NCI-EVS
Closed 1/29/2009 19021 NCI-EVS
Closed 1/29/2009 19022 NCI-EVS
Closed 1/29/2009 19023 NCI-EVS
Closed 1/29/2009 19025 NCI-EVS
Closed 1/29/2009 19026 NCI-EVS
Muhlbradt, Erin
Modify Existing Term
SDTM-TPHASE
Muhlbradt, Erin
Modify Existing Term
SDTM-SOC
Muhlbradt, Erin
Modify Existing Term
SDTM-DICTNAM
Muhlbradt, Erin
Modify Existing Term
SDTM-LBTEST
Muhlbradt, Erin
Modify Existing Term
SDTM-EGTESTCD
Muhlbradt, Erin
Modify Existing Term
SDTM-EGTEST
Muhlbradt, Erin
Modify Existing Term
SDTM-EGTEST
Muhlbradt, Erin
Modify Existing Term
SDTM-UNIT
Muhlbradt, Erin
Modify Existing Term
SDTM-MARISTAT
Closed 1/29/2009 19027 NCI-EVS
Closed 2/3/2009 19115 CDISC
Closed 2/3/2009 19116 CDISC
Closed 2/3/2009 19120 CDISC
Closed 2/3/2009 19122 CDISC
Closed 2/3/2009 19123 CDISC
Closed 2/3/2009 19124 CDISC
Muhlbradt, Erin
Modify Existing Term
SDTM-UNIT
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Closed 2/3/2009 19125 CDISC
Closed 2/4/2009 19140
Closed 2/12/2009 19374
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Mattson, Monica
Celgene Corporation
Create New Term
SDTM-AESEV
Stoner, Gail
Johnson & Johnson
[email protected] New Term
SDTM-NCOMPLT
Closed 2/13/2009 19396
Closed ### 19449 CDISC
Closed ### 19450 CDISC
Closed ### 19451 CDISC
Closed ### 19452 CDISC
Closed ### 19454 CDISC
Closed ### 19455 CDISC
Closed ### 19456 CDISC
Closed ### 19457 CDISC
Austin, Randall
GlaxoSmithKline
Modify Existing Term
SDTM-STENRF
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Closed ### 19458
Closed ### 19460 CDISC
Closed ### 19461 CDISC
Closed ### 19463 CDISC
Closed ### 19464 CDISC
Closed ### 19466 CDISC
Closed ### 19507 NCI Other None
Closed ### 19540
Closed ### 19542
Muhlbradt, Erin
Lockheed Martin
Modify Existing Term
SDTM-FRM
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Quinn, Theresa
Muhlbradt, Erin
Lockheed Martin
Modify Existing Term
SDTM-COUNTRY
Muhlbradt, Erin
Lockheed Martin
Modify Existing Term
SDTM-COUNTRY
Closed ### 19574 CDISC
Closed ### 19575 CDISC
Closed ### 19576 CDISC
Closed ### 19577 CDISC
Closed ### 19578 CDISC
Closed ### 19579 CDISC
Closed ### 19580 CDISC
Closed ### 19581 CDISC
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Closed ### 19582 CDISC
Closed ### 19583 CDISC
Closed ### 19584 CDISC
Closed ### 19585 CDISC
Closed ### 19653
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Gromen, Andreas
Not Provided
[email protected] Existing Term
SDTM-NCOMPLT
Closed ### 19678 Shire
Closed ### 19679 CDISC
Closed ### 19681 CDISC
Closed ### 19682 CDISC
Closed ### 19683 CDISC
Closed ### 19684 CDISC
Closed ### 19685 CDISC
Closed ### 19686 CDISC
Closed ### 19687 CDISC
Closed ### 19688 CDISC
Matejunas, Armand
Modify Existing Term
SDTM-AESEV
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tollk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Closed ### 19689 CDISC
Closed ### 19690 CDISC
Closed ### 19691 CDISC
Closed ### 19692 CDISC
Closed ### 19704 Other
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Tolk, Chris
Modify Existing Term
SDTM-LBTEST
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Lenzen, Mary
Octagon Research Solutions
SDTM-NCOMPLT
Closed ### 19750
Closed 3/5/2009 9:18 19788
Closed ### 19802
Muhlbradt, Erin
Lockheed Martin
Modify Existing Term
SDTM-LBTESTCD
Muhlbradt, Erin
Lockheed Martin
Modify Existing Term
SDTM-LBTESTCD
Muhlbradt, Erin
Lockheed Martin
Modify Existing Term
SDTM-LBTEST
Closed ### 19884 CDASH
Closed ### 19904
Closed ### 20003
Closed ### 20004
Closed ### 20005 All
Nulton-Bodiford, Liz
Modify Existing Term
SDTM-FRM
Muhlbradt, Erin
Lockheed Martin
Modify Existing Term
SDTM-LBTEST
Mary Lenzen
Octagon Research Solutions
Modify Existing Term
SDTM-ETHNIC
Mary Lenzen
Octagon Research Solutions
Modify Existing Term
SDTM-TPHASE
Mary Lenzen
Octagon Research Solutions
Modify Existing Term
Closed ### 20131
Closed 4/6/2009 9:12 20469
Closed ### 20530
Cheng, Yuan
ImClone System
Create New Term
SDTM-LBTEST
Gromen, Andreas
Bayer Schering AG
andreas.gromen@bayerschering. [incorrect e-mail for Andreas]Modify Existing Term
SDTM-LBTEST
Austin, Randall
GlaxoSmithKline
Modify Existing Term
SDTM-LBTESTCD
Closed ### 20704 CDISC
Closed ### 20706 CDISC
Closed ### 20796
Closed ### 20825
Closed ### 20828
Closed ### 20829
Facile, Rhonda
Create New Term
SDTM-UNIT
Facile, Rhonda
Create New Term
SDTM-UNIT
Muhlbradt, Erin
Lockheed Martin
Modify Existing Term
SDTM-LBTEST
Lenzen, Mary
Octagon Research Solutions
Modify Existing Term
SDTM-ETHNIC
Lenzen, Mary
Octagon Research Solutions
Create New Term
SDTM-DOMAIN
Lenzen, Mary
Octagon Research Solutions
Create New Term
SDTM-DOMAIN
Closed ### 20830
Closed ### 20831 Other
Closed ### 20832 Other None
Closed ### 20833 Other
Closed ### 20835 Other
Closed ### 20836 Other
Closed ### 20837 Other
Lenzen, Mary
Octagon Research Solutions
Modify Existing Term
SDTM-DOMAIN
Lenzen, Mary
Octagon Research Solutions
SDTM-TSPARMCD
Lenzen, Mary
Octagon Research Solutions
Lenzen, Mary
Octagon Research Solutions
SDTM-TSPARMCD
Lenzen, Mary
Octagon Research Solutions
SDTM-TSPARM
Lenzen, Mary
Octagon Research Solutions
SDTM-TSPARMCD
Lenzen, Mary
Octagon Research Solutions
SDTM-TSPARM
Closed ### 20838
Closed ### 20839
Closed ### 20856
Closed ### 20857
Closed ### 20858
Closed ### 20859
Closed ### 20860
Lenzen, Mary
Octagon Research Solutions
Create New Term
SDTM-TSPARMCD
Lenzen, Mary
Octagon Research Solutions
Create New Term
SDTM-TSPARM
Lenzen, Mary
Octagon Research Solutions
Create New Term
SDTM-TSPARM
Lenzen, Mary
Octagon Research Solutions
Create New Term
SDTM-TSPARMCD
Lenzen, Mary
Octagon Research Solutions
Create New Term
SDTM-TSPARM
Lenzen, Mary
Octagon Research Solutions
Create New Term
SDTM-TSPARMCD
Lenzen, Mary
Octagon Research Solutions
Create New Term
SDTM-TSPARM
Closed ### 20908
closed ### 20930 Other
closed ### 20964 NCI/EVS
closed ### 20965 NCI/EVS
closed ### 20966 NCI/EVS
Randall Austin
GlaxoSmithKline
[email protected] New Term
SDTM-EGSTRESC
Mauron, Charlotte
Hoffmann-La Roche
SDTM-POSITION
Quinn, theresa
Modify Existing Term
Not provided
Quinn, Theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
closed ### 20967 NI/EVS
closed ### 20968 NCI/EVS
closed ### 20969 NCI/EVS
closed ### 20970 NCI/EVS
closed ### 20971 NCI/EVS
closed ### 20972 NCI/EVS
closed ### 20973 NCI/EVS
closed ### 20974 NCI/EVS
closed ### 20975 NCI/EVS
closed ### 20977 NCI/EVS
closed ### 20978 NCI/EVS
closed ### 20980 NCI/EVS
quinn, theresa
Modify Existing Term
Not provided
quinnt, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
closed ### 20981 NCI/EVS
closed ### 20982 NCI/EVS
closed ### 20985 NCI/EVS
closed ### 21352 J&J
closed ### CDISC
closed ### 21353 J&J
closed ### 21398 Merck
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
quinn, theresa
Modify Existing Term
Not provided
Pemble, Nik
[email protected] Existing Term
SDTM-LBTESTCD
Comment on item 18856
Tolk, Chris
Modify Existing Term
SDTM-LBTESTCD
Pemble, Nik
[email protected] Existing Term
SDTM-LBTESTCD
ONeill, Debra
[email protected] New Term
SDTM-LBTEST
closed ### 21416
Closed 6/3/2009 8:19 21561 IBM
Closed 6/3/2009 8:32 21562
Closed ### 21778
Closed ### 21778
Vaughn, Carol
sanofi-aventis
[email protected] New Term
SDTM-ACN
Wientges, Jens
Modify Existing Term
SDTM-UNIT
Wientges, Jens
IBM Deutschland GmbH
Modify Existing Term
SDTM-UNIT
Dong, Fugui
Pharmanet
[email protected] New Term
SDTM-LBTEST
Dong, Fugui
Pharmanet
[email protected] New Term
SDTM-LBTEST
Closed ### 21813 CDISC
Closed ### 21869
Closed ### 22086
Closed ### 22087
Closed 7/6/2009 8:23 22116 IBM Other
Tolk, Chris
[email protected] Existing Term
SDTM-UNIT
Dong, Fugui
Pharmanet
Create New Term
SDTM-VSTEST
Dong, Fugui
Pharmanet
Create New Term
SDTM-LBTEST
Dong, Fugui
Pharmanet
Create New Term
SDTM-LBTEST
Wientges, Jens
SDTM-COUNTRY
Closed ### 22280
Closed ### 22292 Gromen
Closed ### 22324
Vaughn, Carol
Sanofi-Aventis
[email protected] New Term
SDTM-TOXGR
Bayer Schering Pharma
Create New Term
SDTM-UNIT
Haglund, Tore
AstraZeneca
Create New Term
SDTM-VSTEST
Closed ### 22356
Closed ### 22357
Closed ### 22359 None
Closed ### 22360 None
Closed ### 22361 None
Lenzen, Mary
Octagon Research Solutions
[email protected] New Term
SDTM-TSPARMCD
Lenzen, Mary
Octagon Research Solutions
[email protected] New Term
SDTM-TSPARM
Lenzen, Mary
Octagon Research Solutions
Lenzen, Mary
Octagon Research Solutions
Lenzen, Mary
Octagon Research Solutions
Closed ### 22362 None
Closed ### 22464
Lenzen, Mary
Octagon Research Solutions
SRIVASTAVA, RANJANA
Booz-Allen- Hamilton
Modify Existing Term
SDTM-TOXGR
Closed ### 22485
Closed ### 22628
Closed ### 22629
Randall Austin
GlaxoSmithKline
[email protected] Existing Term
SDTM-STENRF
Pallas, MIchelle
Genentech
Create New Term
SDTM-ACN
Pallas, Michelle
Genentech
Create New Term
SDTM-ACN
Closed ### 22642 None
Closed ### 22775
Closed ### 22970
Closed ### 23782 Ort, Jack
Wientges, Jens
IBM Deutschland GmbH
Modify Existing Term
Omundsen, Erica
CDISC Corporate Member
Create New Term
SDTM-LBTESTCD
Ramage, David
Daiichi Sankyo
Modify Existing Term
SDTM-EVAL
ResearchPoint
Create New Term
SDTM-FREQ
Closed ### 24313
Closed ### 24744 NCI EVS
Closed ### 24798 Merck
Closed ### 24799 Merck
Closed ### 24800 Merck
Closed ### 25174 LMCO
Van-Keer, Marie-rose
sanofie-aventis
Create New Term
SDTM-OUT
quinn, theresa
Modify Existing Term
SDTM-LOC
ONeill, Debra
Create New Term
SDTM-LBTEST
ONeill, Debra
Create New Term
SDTM-LBTESTCD
ONeill, Debra
Modify Existing Term
SDTM-LBTEST
Muhlbradt, Erin
[email protected] Existing Term
SDTM-UNIT
Open ### 25190 EGSTRESCHarrington, Brian
ERT (eResearch Technology)
Create New Term
Codelist C67154
C 35266 - Anisocytois
HYPO
For LBTEST and LBTESTCD - May-Hegglin Anomaly
ALT
C42570, C68858 in codelist C71620
Pokilocytosis
C49686 Phase IIa Trial
New Term or Codelist/Existing Term or Code Number
C49688 Phase IIb Trial
C49476 LOINC
C74610 Dohle Bodies
NOTCHED T-WAVES
BIFASICULAR BLOCK
ATRIAL FLUTTER
C44277 Degree Fahrenheit (F)
DIVORCED
C49399 CONGENITAL, FAMILIAL AND GENETIC DISORDERS
C42546 Newton
C74688
C64470
C64471
AST
C64487
C74753
C61032
Two new terms: LIFE-THREATENING and FATAL
SUBJECT REFUSED STUDY TREATMENT
C66728 - add term BEFORE/DURING
C64549
C64550
C64604
C74782
C74676
C64847
C64851
C74739
C42956, C42945, C42899, C42995, C42926, C42951
C64818
C64919
C64820
C74654
C64821
Life Threatening
C17095 Reunion
C16334 Bermuda
Ery. Mean Corpuscluar HB Concentration C64798
Modify definition text for Microcytes
Monocytes/C64823
Monocytes/Leukocytes /C64824
Myeloblasts/Leukocytes / C74646
Myelocytes/Leukocytes /C64826
Neutrophils
Neutrophils Band Form / C64830
Neutrophils Band Form/Leukocytes / C64831
Neutrophils/Leukocytes / C64827
Pelger Huet Anomaly / C74617
Phosphate /C64857
C48227
Severe term / C41340
Platelets / C51951
Poikilocytes/Erythrocytes / C74649
RBC /C51946
RBCNUC / C74705
Nucleated Erythrocytes/Erythrocytes / C74647
Reticulocytes / C51947
Reticulocytes/Erythrocytes /C64828
Thyroxine, Free /C74786
Dacryocytes /C64801
Urate /C64814
WBC /C51948
Prolymphocytes/Leukocytes /C64829
Lymphocytes /C51949
Not completed
C74634 Bite Cells/Erythrocytes
C74761, C74894, C74753
C74792, C75386 Somatotropin and Growth Hormone Measurement
C42966, C42993, C42887, C42994
CDISC PT Folic Acid
C66790
C49687
All
Indican
C74616
C67154
PACK YEARS
QD
C74768
C66790 - Patient Ethnic Group
Domain - C66734
Domain - C66734
Delete term Adverse Event Dictionary (C49700)
MHDICT (CC49702) in TSPARMCD (C66738)
Medical Dictionary (C49702) in TSPARM(C67152)
Correct term C49566 for BM code in Domain (C66734 ) codelist
Delete term AEDICT ( C49700) in TSPARMCD (C66738) codelist
DRUGDICT (C49701) in TSPARMCD (C66738) codelist
Delete term Drug Dictionary (C49701) in TSPARM(C67152) codelist
TSPARMCD (C66738)
TSPARM (C67152)
new term OBJSEC to the TSPARM C67152) codelist
new term OBJSEC to the TSPARMCD (C66738)
TSPARMCD (C66738) codelist
new term "Trial Secondary Objective" to the TSPARM C67152)
new term "Sponsoring Organization" to the TSPARM (C67152)
none
C62174
C49641
C28233
C33507
C34786
C38235
C72554
C42555
C42554
C42558
C44277
C49641
C54711
C68915
C70511,C70512,C70513, c71168
C71061
C71089
C71325
C74700
FGRANCS - change to CSFGRAN
HYPO
LACTICAC
Protein 24 Hr
DOSE DELAYED
C70526
Code C70527 of Codelist C71620
Fragment D-dimer
Fragment D-dimer
Knee to Heel Length
Partial pressure of carbon dioxide
Oxygen, partial pressure
C66786 / COUNTRY
for the all terms in the unit code list add synonym with mcg for u
U/L
SAD - Sagittal Abdominal Diameter
EXISTRT
Add TSPARM (Name of Treatment)
New Term TSPARMCD = OBJ
Existing Treatment (TSPARM) for EXISTRT (TSPARMCD)
New TSPARMCD = TRT for "Name of Treatment"
New Term TSPARM = OBJECTIVE
New Term: Grade 0 Adverse Event; C66784, C66784, C66784, C66784, C66784
STENRF
MULTIPLE
INFUSION
LBTESTCD, C65047
New Term needed for Total Bilirubin
C78735
Every a.m. / Every p.m.
Add Not Recovered/Stabilized
C32996
Cortisol, Free
CORTISLF
Cortisol
mL
Other
Detailed Description
II
II
HYPO is not specific enough.Change HYPO to HYPOCROM II
II
Add synonymAdd SGPT as a synonym. II
II
II
II
Change Type
To be consistent with other "Ratio" terms.Remove "Ratio" from Albumin/Creatinine Ratio.
Use the cell name rather than the diagnosis.Change Anisocytosis to Anisocytes
The definition is not specific enough. Need to add the additional text.For LBTEST and LBTESTCD - May-Hegglin AnomalyThe new definition should read: A measurement of the May-Hegglin Amonaly (which is characterized by large, misshapen platelets and the presence of Dohle bodies in leukocytes) in a blood specimen.
This is a topic we had discussed ealier and decided to wait until this change process was implemented. The terms C42570 and C68858 have the same CDISC PT of m3. From the definitions provided, they seem to represent different concepts.2 different concepts with same PT (m3)I cut-and-paste some additional very useful information provided at the time by Connie (sorry for putting you in the spot!: I did a little digging and these two concepts are in fact two distinct concepts with two different definitions.
ModificationRemap Pokilocytosis to Pokilocyte MeasurementCN 35267 is mapped to the lab result and should be mapped to Poikilocyte Measurement, which needs to be created. The CDISC PTs and definitions are correct.
Misspelling in definition.The word 'Refered' spelled wrong - Should be 'referred'Old Def: A clinical research protocol generally refered to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. New Def: A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question.
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Misspelling in definition.Misspelling in definition of Phase IIb Trial - Refered change to ReferredOld Def: A clinical research protocol generally refered to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate si
Misspelling in definitionCharacteristic is misspelled in defNew Def: A class of disorders that encompasses conditions resulting from a congenital, familial hereditary trait or genetic abnormality as is manifested by a characteristic set of symptoms and signs.
Double 'the' in definition.Take one 'the' in definition of LOINCNew Def: Published by The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology.
Misspelling in definition.Change bodie to body in definitionNew Def: A measurement of the Dohle body (blue-gray, basophilic, leukocyte inclusions located in the peripheral cytoplasm of neutrophils) in a biological specimen.
Misspelling in definitionChange 'occuring' to 'occurring' in definitionNew: Any depression occurring in a positive t wave.
Misspelling in definitionChange 'occuring' to 'occurring' in defChange 'occuring' to 'occurring' in definition
Grammar in definition.Add word 'is' between 'generally' and 'at' in def.New: An electrocardiographic finding of an organized rhythmic contraction of the atria which is generally at a rate of 200-300 beats per minute. (NCI)
Double (NCI) in def.Remove (NCI) from end of CDISC definition.New: The Fahrenheit temperature scale is named after the German physicist Gabriel Fahrenheit (1686-1736), who proposed it in 1724. In this scale, the freezing point of water is 32 degrees Fahrenheit and the boiling point is 212 degrees, placing the boilin
Misspelling in definitionMarriage is spelled wrong in the definitionMarriage is spelled wrong in def.
II
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Stylistic inconsistency in definition.Change meter/sec(2) to meter/sec2 in definition.New: A unit of force which, when applied in a vacuum to a body having a mass of one kilogram, causes an acceleration of one meter/sec2. It is equal to 10E5 dynes.
The term should be Barbiturates instead of Barbiturate because we are measuring the drug class. This is consistant with other drug classes.Make the term BarbituatesThe term should be Barbiturates instead of Barbiturate because we are measuring the drug class. This is consistant with other drug classes.
To be consistent with other definitions change A count of the basophils per unit of a biological specimen to A measurement of of the basophils per unit of a biological specimen.Change definition to A measurement of of the basophils per unit of a biological specimen.To be consistent with other definitions change A count of the basophils per unit of a biological specimen to A measurement of of the basophils per unit of a biological specimen.
Change text from measure to measurement to be consistent and use ther word measurement for all termsChange for measure to measurementChange text from measure to measurement in the following text. New text should read: A relative measurement (ratio or percentage) of the basophils to leukocytes in a biological specimen.
Add synonym of SGOTAdd synonym of SGOTAdd synonym of SGOT
Change the text from measure to measurement. New text: A relative measurement (ratio or percentage) of the blasts to leukocytes in a biological specimen. All should have the word measurement to be consistent.Change measure to measurement.Change the text from measure to measurement. New text: A relative measurement (ratio or percentage) of the blasts to leukocytes in a biological specimen.
The CDSIC submission value should be without the word ratio. New text:BUN/Creatinine. There are only a couple of values that have the word ratio. THis will make all of the ratio terms consistent.Remove the word Ratio from CDISC submission valueThe CDSIC submission value should be without the word ratio. New text:BUN/Creatinine. There are only a couple of values that have the word ratio. THis will make all of the ratio terms consistent.
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Add Total Cholesterol as a synonym.Add Total Cholesterol as a synonym.Add Total Cholesterol as a synonym.
Need more granularity in the differentiation of severity of AEsAESEV new termsRequest the addition of two new terms "LIFE-THREATENING and FATAL" to the AESEV codelist. In addition to providing more detail for the differentiation of severity of an AE that is not categorized by a standard terminology, it would also provide a more log
Many of our study designs have an extended period of post-treatment follow up (3-6 months) that includes both efficacy and safety assessments. If a subject discontinues study drug prematurely, most protocols require that they still complete the full follow-up period. For this reason, we collect and report on disposition for the treatment phase of the study separately from the follow up phase. We have situations where the subject refuses further study drug, but is willing to stay in the study and complete the follow up period. Oncology colleagues have indicated that this is not uncommon and they wish to include this reason on the CRF for use in summary tables. None of the existing REAS terms seems appropriate. We specifically do not want to use "Withdrawal by subject" because that is widely interpreted as meaning the subject refuses participation/data collection of any kind.Add "SUBJECT REFUSED STUDY TREATMENT" to SDTM-NCOMPLT codelistPlease see text in Justification section.
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Add synonym.Add synonym.Add synonym Oestradiol. II
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Codelist is not extensible but does not cover all scenariosAdd BEFORE/DURING term to STENRF codelistCodelist STENRF currently has terms AFTER, BEFORE, DURING, DURING/AFTER, UNKNOWN. If a con med CRF reports that ONGOING?=No, but does not include a stop time, we know that CMENRF is not "AFTER", but we don't know if it was BEFORE or DURING. (If it started DURING then we know it ended DURING, but if it started BEFORE we have no clue as to when it ended.) A new term BEFORE/DURING needs to be added to parallel the wishiwashiality of the existing term DURING/AFTER. Otherwise the sponsor cannot represent the specificity of information that is available. This addition will enable the codelist to be "closed" and still cover all cases. Recommend the following description, to be consistent with other existing descriptions in the codelist: "Before a certain point or period in time or within a certain period of time."
Correct text to match other terms.Modify definition to A measurement of the elliptically shaped erythrocytes in a biological specimen. Add synonym Ovalocytes.Modify definition to A measurement of the elliptically shaped erythrocytes in a biological specimen. Add synonym Ovalocytes.
Consistwncy with other definitions.Modify definitionModify definition to A measurement of the eosinophils per unit fo a biological specimen.
Consistency in definitions.Modify definition.Modify definition to A relative measurement (ratio or percentage) of the eosinophils to leukocytes in a biological specimen.
All of the other vitamins are referred to by VIT. Change to be consistent.Change term to VITB9Modify the existing term of FOLICAC to VITB9.
Error in definition.Change from transpeptidase to tranferaseThe definition should read: A measurement of the gamma glutamyl transferase in a biological specimen.
Add synonym for HCGAdd synonym for HCGAdd synonym Pregnancy Test
Add synonym Glutamic Acid.Add synonym Glutamic Acid.Add synonym Glutamic Acid for Glutamate.
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The values in column E should equal the values in column F in this codelist.Please make the Submission Value equal to PT on row 407-412 of published spreadsheetOn rows 407 to 412 of published spreadsheet, the CDISC submission value in column E does not match the CDISC preferred term in column F. This is one of those codelists in which the term in column E should equal the term in Column F. It looks like a copy and paste error.
Consistency with other definitionsModfiy definition for Lymphocytes AtypicalNew text should read: A measurement of the atypical lymphocytes per unit in a biological specimen.
Consistent definition.Change measure to measurementDefinition new text for Lymphocytes Atypical/Leukocytes: A relative measurement (ratio or percentage) of the lymphocytes to leukocytes in a biological specimen.
Consistency of definitionChange measure to measurement for LYMLECorrect text for LYMLE is: A relative measure (ratio or percentage) of the atypical lymphocytes to leukocytes in a biological specimen.
Definition consistencyChange definitionChange definition of Reactive Lymphocytes/Lymphocytes to: A relative measurement (ratio or percentage) of the reactive lymphocytes (lymphocytes which have become large due to an antigen reaction) to all lymphocytes in a biological specimen.
Consistent definitionModify definition for MacrocytesNew text should read: A measurement of the macrocytes per unit of a biological specimen.
Life Threatening is listed as a CDISC PT; however, it is not actually a part of any codelist. 4 is the PT for the SDTM-TOXGR. I suggest either changing the designation of Life Threatening to a SY or adding it to a codelist.Life Threatening is not a part of any codelistSee Justification
The definition is incorrect, gramatically.Minor change to definition for Reunion, the country.Old Def: An Southern Africa, occupying an island in the Indian Ocean, east of Madagascar. New Def: A country in Southern Africa, occupying an island in the Indian Ocean, east of Madagascar.
Bermuda requires a definition.No definition on CT spreadsheet for BermudaPlace definition for Bermuda on Controlled Terminology spreadsheet: A group of islands in the North Atlantic Ocean, east of South Carolina.
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Change Ery. Mean Corpuscluar HB Concentration to Ery. Mean Corpuscluar HGB Concentration to add the B in HB for consistency in the abbreviation of hemaglobin.Change Ery. Mean Corpuscluar HB Concentration to Ery. Mean Corpuscluar HGB ConcentrationChange Ery. Mean Corpuscluar HB Concentration to Ery. Mean Corpuscluar HGB Concentration to add the B in HB for consistency in the abbreviation of hemaglobin.
Consistency in text.New text should read: A measurement of the microcytes per unit of a biological specimen.New text should read: A measurement of the microcytes per unit of a biological specimen.
Consistent definition.New text should read: A measurement of the monocytes per unit of a biological specimen.New text should read: A measurement of the monocytes per unit of a biological specimen.
Change to make definition consistent with other terms.New text should be: A relative measurement (ratio or percentage) of the monocytes to leukocytes in a biological specimen.New text should be: A relative measurement (ratio or percentage) of the monocytes to leukocytes in a biological specimen.
Text change for consistency.New text should be: A relative measurement (ratio or percentage) of the myeloblasts to leukocytes in a biological specimen.New text should be: A relative measurement (ratio or percentage) of the myeloblasts to leukocytes in a biological specimen.
Consistent text in definition.New text should be: A relative measurement (ratio or percentage) of the myelocytes to leukocytes in a biological specimen.New text should be: A relative measurement (ratio or percentage) of the myelocytes to leukocytes in a biological specimen.
Consistent definition.New text: A measurement of the neutrophils per unit of a biological specimen.New text: A measurement of the neutrophils per unit of a biological specimen.
Consistent textNew text: A measurement of the banded neutrophils per unit of a biological specimen.New text: A measurement of the banded neutrophils per unit of a biological specimen.
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Consistent TextNew test: A relative measurement (ratio or percentage) of the banded neutrophils to leukocytes in a biological specimen.New test: A relative measurement (ratio or percentage) of the banded neutrophils to leukocytes in a biological specimen.
Text consistencyNew test: A relative measurement (ratio or percentage) of the neutrophils to leukocytes in a biological specimen.New test: A relative measurement (ratio or percentage) of the neutrophils to leukocytes in a biological specimen.
Better understandingNew text: A measurement of the Pelger Huet Anomaly (neutrophils and eosinophils nuclei appear rodlike, spherical or dumbbell shapped) in a biological specimen.New text: A measurement of the Pelger Huet Anomaly (neutrophils and eosinophils nuclei appear rod like, spherical or dumbbell shaped) in a biological specimen.
Add synonymAdd synonym: PhosphorusAdd synonym: Phosphorus
A clarification is needed if this is the CDISC indented definition or if this will be changed, because the exact same term has been used in my organization with a different definition.Lost to follow-up defintion change requestThe CDISC defintion for the "Lost to follow-up" says: "The loss or lack of continuation of follow-up after a study has officially closed. See Follow-up. (NCI)" In my organization this term was used rather with a definition as follows: "The lost to follow-up means that there was no further contact, independent of the study epoch where the subject got lost."
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Correct error, remove )Correct error, remove ) in definition II
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Correct spelling errorNew term: Thyroxine, Free I
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Shire's physicians rationale and support of their position: We believe the CDISC definition itself is 'too severe' and the definition overlaps a lot with Serious AE. From our perspective, there needs to be a more clear distinction.Modify definiton of severe in AESEV codelistShire’s current definition of “severe” - : The AE is incapacitating and the subject is unable to work or complete usual activity. CDISC’s current definition of “severe” - : A type of adverse event that requires intensive therapeutic intervention.The event interrupts usual activities of daily living, or significantly affects clinical status. The event possesses a significant risk of harm to the research participant and hospitalization may be required Shire’s physicians preferred definition of “severe” - : The event interrupts usual activities of daily living, or significantly affects clinical status, and/or a type of AE that requires intensive therapeutic intervention.
Consistent definitionNew definition: A measurement of the platelets in a biological specimen.
Add synonym and modify definition for consistency.Add Red Blood Cells as synonym and change definition as below.
Add synonym for RBCNUCAdd synonym: Nucleated Red Blood Cells
Add synonym for Nucleated Erythrocytes/ErythrocytesSynonym is: Nucleated Red Blood Cells/Erythrocytes
Consistent text definitionNew text: A measurement of the reticulocytes per unit of a biological specimen.
Consistent documentation of definitionNew text: A relative measurement (ratio or percentage) of reticulocytes to erythrocytes in a biological specimen.
Change definition to be consistent with other terms and add synonym.New synonym: Tear Shaped Erythrocytes. New definition: A measurement of dacryocytes per unit of a biological specimen.
Add synonymNew synonym: Uric Acid II
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Add synonym: White Blood CellsAdd synonym: White Blood Cells
Change definition for consistencyNew text: A relative measurement (ratio or percentage) of prolymphocytes to leukocytes in a biological specimen.
Consistent definitionNew text: A measurement of the lymphocytes per unit of a biological specimen.
Change definition of NCOMPLT codlist (C66727) to "If the subject completed the study or segment of the study (e.g. Treatment if data is collected at that granularity) then the term will be "COMPLETED". If the subject does not complete the study or segment of the study then this is the reason that a subject discontinued." Current definition of "The reason that a subject was discontinued from a clinical trial." does not encompass the fact that the subject could complete a portion of the trial. Current defintion is not consistent with CDISC SDTMIG (Study Data Tabulation Implementation Guide).Change definition of NCOMPLT codlist (C66727)Change definition of NCOMPLT codlist (C66727) to "If the subject completed the study or segment of the study (e.g. Treatment if data is collected at that granularity) then the term will be "COMPLETED". If the subject does not complete the study or segment of the study then this is the reason that a subject discontinued." Current definition of "The reason that a subject was discontinued from a clinical trial."
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C74792, C75386 are potential synonyms. Technically, Somatotrophin and Growth Hormone are analogous; both are names for the 191kDa hormone that is produced by somatotroph cells in the anterior pituitary gland (other synonyms also include HGH, Human Growth Hormone). The term somatotropin (without the h) is an analogous term that indicates the recombinant form of Somatotrophin, or a structurally and functionally identical hormone that is produced by bacterial expression systems for clinical use.C74792, C75386 are potential synonyms in LBTEST and LBTESTCD codelistsThe use of the term 'growth hormone' as a general class of hormones may be used to denote any hormone that stimulates cell growth in the popular lexicon. I am unsure whether CDISC is using the term Growth Hormone Measurement as a broad category to denote the measurement of any 'growth' hormones or whether it really does mean Somatotrophin. In the SDTM both of these terms are synonyms of each other which makes me think that perhaps CDISC does really mean Growth Hormone = Somatotrophin. CDISC needs to determine whether these two should remain separate on the codelist or if not, to pick one PT and create the other term as a synonym. Also CDISC needs to resolve the issue of whether they mean Somatotrophin or Somatotropin (without the h).
C74634 Bite Cells/Erythrocytes appears twice in LBTEST and LBTESTCD codelist.C74634 Bite Cells/Erythrocytes appears twice in LBTEST and LBTESTCD codelistC74634 Bite Cells/Erythrocytes appears twice in LBTEST and LBTESTCD codelist. Remove one.
All other terms of this type do not contain the word ratio. For consistency CDISC may want to consider removing the word ratio from the PT.Consistency issues in CDISC PTThe CDISC PT for C74761: Albumin/Creatinine Ratio, C74894: Albumin/Globulin Ratio, C74753: BUN/Creatinine Ratio all contain the word 'Ratio'. All other terms of this type do not contain the word Ratio in the PT. For consistency, CDISC may want to consider removing the term Ratio from the PT.
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These abbreviations will be how these terms are recorded on the CRF by site personnel. Addition of these synonyms will align CDASH IG appendix A with SDTM fully.Add synonyms to align CDASH IG appendix A with SDTM fullyPlease add the terms as CDISC synonyms: C42966 Ointment - oint; C42993 Suppository - supp; C42887 Aerosol - aer; C42994 Suspension - susp.
See request 19454Change CDISC PT Folic Acid to Vitamin B9Im conjunction with decision regarding change request 19454, please change CDISC PT from Folic Acid to Vitamin B9. Keep Folic Acid as a synonym.
Change name of codelist from "Patient Ethnic Group" to "Ethnic Group". 1)codelist is not limited to patients. 2) Not consistent with other codelist names - "Race" is called "Race" and not "Subject Race".Change name of codelist from "Patient Ethnic Group" to "Ethnic Group"Change name of codelist from "Patient Ethnic Group" to "Ethnic Group"
Typo in term "Phase IIIaTrial" needs to be corrected to "Phase IIIa Trial". Space is missing.Typo in term "Phase IIIaTrial" needs to be corrected to "Phase IIIa Trial". Space is missing.Typo in term "Phase IIIaTrial" needs to be corrected to "Phase IIIa Trial". Space is missing.
Change "CDISC Code List" drop down list in this form to 1) remove "SDTM" from each codelist name since these codelists are not just applicable for SDTM so it's very confusing and misleading 2) please sort codelist alphabetically - order in dropdown list seems to be random and it's difficult to find a codelist without searching through the whole list.Change "CDISC Code List" drop down listChange "CDISC Code List" drop down list in this form to 1) remove "SDTM" from each codelist name since these codelists are not just applicable for SDTM so it's very confusing and misleading 2) please sort codelist alphabetically - order in dropdown list seems to be random and it's difficult to find a codelist without searching through the whole list.
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Urine Indican Test, also known as Obermeyer test, is one type of Urine Metabolism Tests. This test serves as an indication of protein Metabolism status in digest duct and it is used in clinical trial.indican testIn normal urine, the amount of indican excreted is small. It is increased with high protein diets or inefficient protein digestion. If not digested properly, or if the wrong type of proteins are ingested, bowel putrefaction can occur. Problems with protein digestion can be caused by overgrowth of anaerobic bacteria, intestinal obstruction, stomach cancer, low stomach acid, parasitic infections, malabsorptive syndromes (sprue, etc.), fungal infections, lack of digestive enzymes, or liver problems. Please see following website for more information: http://biocenterlab.org/tests/urine/indican.shtml
Clarify defintion, because it is unclearPappenheimer Bodies and SiderocytesCDISC definition of Pappenheimer Bodies is unclear. Pappenheimer Bodies are found in siderocytes. However, the CDISC defintion says: A measurement of the Pappenheimer Bodies (violet or blue staining, ferritin granules usually found along the periphery of the red blood cells) in a biological specimen. Does this mean that the number of Pappenheimer Bodies per siderocyte is counted or is it possible to use this for the count of siderocytes or aren't Pappenheimer Bodies counted?
Correct typos, remove duplicates3 lab test entries may have issues (typo, duplicates)1) C74630 C65047 Laboratory Test Code BLASTLM BLASTLM Leukemic Blasts; Lymphocytes; Lymphoblasts; Immunoblastic - Should the second synonym be 'Lymphocyte Blasts'rather than 'Lymphocytes'? 2) Within the 2009-02-17 posted spreadsheet, there are duplicate rows for the term BTECERBC: LBTEST: rows 1367 and 1538 (definitions are slightly different but the terms are the same) LBTESTCD: rows 945 and 1116 (ditto) 3) There appear to be 2 codes for the same test, where the TESTCD is simply worded differently: C74767 C65047 Laboratory Test Code FGRANCS FGRANCS Fine Granular Casts A measurement of the fine granular casts present in a urine specimen. C74769 C65047 Laboratory Test Code CSGRANF CSGRANF Granular Fine Casts A measurement of the fine granular casts present in a urine specimen.
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Pack year is a commonly term used to describe the amount a person has smoked over time. One pack year is defined as 20 manufactured cigarettes (1 pack) smoked per day for one year.Pack Years = Pack year is a term used to describe the amount a person has smoked over time. One pack year is defined as 20 manufactured cigarettes (1 pack) smoked per day for one year.The CDASH Medical History team proposes that "Pack Years" be added to the terminology code lists. Pack Years is a commonly term used to describe the amount a person has smoked over time. One pack year is defined as 20 manufactured cigarettes (1 pack) smoked per day for one year.
The CDASH project team requests that QD be added the terminology codelists to mean every day. The closest term is "Q24 hr", however, QD is commonly used by clinicians in medical charts and on case report forms.Add QD to the terminology code listsThe CDASH project team requests that QD be added the terminology codelists to mean every day. The closest term is "Q24 hr", however, QD is commonly used by clinicians in medical charts and on case report forms.
Misspelling in definition - Change 'course' to 'coarse'Mispelling in definition of C74768Old Def: A measurement of the granular (course and fine) casts present in a urine specimen. New Def: A measurement of the granular (coarse and fine) casts present in a urine specimen.
Name of this codelist should be changed to Subject Ethnic Group as per page 272 of the SDTMIGv3.1.2 - row 1 in the table.Change name of codelist to Subject Ethnic GroupName of this codelist should be changed to Subject Ethnic Group as per page 272 of the SDTMIGv3.1.2 - row 1 in the table.
Add new term for CE - Clinical Events to Domain codelist as per page 274 of SDTMIGv3.1.2.Add Clinical Events to Domain codelist.Add new term for CE - Clinical Events to Domain codelist as per page 274 of SDTMIGv3.1.2.
Add new term FA (Findings About) to the Domain codelist as per page 274 of SDTMIGv3.1.2.Add new term FA (Findings About) to the Domain codelistAdd new term FA (Findings About) to the Domain codelist as per page 274 of SDTMIGv3.1.2.
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Correct BM to "Bone Measurements" in the Domain codelist as per page 277 of SDTMIGv3.1.2. Current description is "Bone Mineral Density (BMD) Data" Correct term C49566 for BM code in Domain (C66734 ) codelistCorrect BM to "Bone Measurements" in the Domain codelist as per page 277 of SDTMIGv3.1.2. Current description is "Bone Mineral Density (BMD) Data"
Delete term AEDICT ( C49700) in TSPARMCD (C66738) codelist as per page 279 of SDTMIGv3.1.2.Delete term AEDICT ( C49700) in TSPARMCD (C66738) codelistDelete term AEDICT ( C49700) in TSPARMCD (C66738) codelist as per page 279 of SDTMIGv3.1.2.
Delete term Adverse Event Dictionary (C49700) in TSPARM (C67152) codelist as per page 279 of SDTMIGv3.1.2.Delete term Adverse Event Dictionary (C49700) in TSPARM (C67152) codelistDelete term Adverse Event Dictionary (C49700) in TSPARM (C67152) codelist as per page 279 of SDTMIGv3.1.2.
Delete term DRUGDICT (C49701) in TSPARMCD (C66738) codelist as per page 280 of SDTMIGv3.1.2.Delete term DRUGDICT (C49701) in TSPARMCD (C66738) codelistDelete term DRUGDICT (C49701) in TSPARMCD (C66738) codelist as per page 280 of SDTMIGv3.1.2.
Delete term Drug Dictionary (C49701) in TSPARM(C67152) codelist as per page 280 of SDTMIGv3.1.2.Delete term Drug Dictionary (C49701) in TSPARM(C67152) codelistDelete term Drug Dictionary (C49701) in TSPARM(C67152) codelist as per page 280 of SDTMIGv3.1.2.
Delete term MHDICT (CC49702) in TSPARMCD (C66738) codelist as per page 281 of SDTMIGv3.1.2.Delete term MHDICT (CC49702) in TSPARMCD (C66738) codelistDelete term MHDICT (CC49702) in TSPARMCD (C66738) codelist as per page 281 of SDTMIGv3.1.2.
Delete term Medical Dictionary(C49702) in TSPARM(C67152) codelist as per page 281 of SDTMIGv3.1.2.Delete term Medical Dictionary(C49702) in TSPARM(C67152)Delete term Medical Dictionary(C49702) in TSPARM(C67152) codelist as per page 281 of SDTMIGv3.1.2.
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Add new term OBJPRIM as per page 281 of SDTMIGv3.1.2.Add new term OBJPRIMAdd new term OBJPRIM as per page 281 of SDTMIGv3.1.2.
Add new term "Trial Primary Objective" to TSPARM (C67152)Add new term "Trial Primary Objective" to TSPARM (C67152)Add new term "Trial Primary Objective" to TSPARM (C67152) as per page 281 of SDTMIGv3.1.2.
Add new term OBJSEC to the TSPARM C67152) codelist as per page 281 of SDTMIGv3.1.2.Add new term OBJSEC to the TSPARM C67152) codelistAdd new term OBJSEC to the TSPARM C67152) codelist as per page 281 of SDTMIGv3.1.2.
Add new term OBJSEC to the TSPARMCD (C66738) codelist as per page 281 of SDTMIGv3.1.2.Add new term OBJSEC to the TSPARMCD (C66738) codelistAdd new term OBJSEC to the TSPARMCD (C66738) codelist as per page 281 of SDTMIGv3.1.2.
Add new term "Trial Secondary Objective" to the TSPARM C67152) codelist as per page 281 of SDTMIGv3.1.2.Add new term "Trial Secondary Objective" to the TSPARM C67152)Add new term "Trial Secondary Objective" to the TSPARM C67152) codelist as per page 281 of SDTMIGv3.1.2.
Add new term SPONSOR to the TSPARMCD (C66738) codelist as per page 281 of SDTMIGv3.1.2.Add new term SPONSOR to the TSPARMCD (C66738) codelistAdd new term SPONSOR to the TSPARMCD (C66738) codelist as per page 281 of SDTMIGv3.1.2.
Add new term "Sponsoring Organization" to the TSPARM (C67152) codelist as per page 281 of SDTMIGv3.1.2.Add new term "Sponsoring Organization" to the TSPARM (C67152) codelistAdd new term "Sponsoring Organization" to the TSPARM (C67152) codelist as per page 281 of SDTMIGv3.1.2.
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MisspellIleumdefinition ilium should be ileum I
Expand ECG Results listExpand ECG Results listRequest from Brian Harrington: These findings fall under the “Result” code list. Please see the below from our Director of International Cardiology: An authoritative reference would be Chou’s Electrocardiography In Clinical Practice, 5th Ed., by Surawica and Knilans (Saunders, 2001). Definitions: AV MOBITZ I - AV conduction block characterized by gradual lengthening of the PR interval leading to a P wave which is not conducted, and a shortening of the PR after the nonconducted P wave; AV MOBITZ II - AV conduction block characterized by abrupt AV block without a change in the PR interval before or after the nonconducted P wave; ARTIFICIAL PACEMAKER - ECG pattern recorded in a subject who has either a permanent or temporary electronic pacemaker (or Implantable Cardiac Defibrillator with pacing capabilities); PROLONGED QTC - Prolonged QT interval (corrected for heart rate) which is associated with increased risk of sudden death. In addition, we are requesting the removal of the current finding (U WAVES) and replace it with the new finding (U WAVES ABNORMAL). This is due to all U waves not being abnormal.
Clarify semi-fowlers versus semi-supine, as they are used as synonyms and semi-fowlers not used commonly as a term in trial protocols.Body position of semi-fowlers versus semi-supine needs clarificationIn the clinical trial context, blood pressure is most commonly measured in the supine and semi-supine position. These are the common terms used, used by the study sites. Feedback received is that terms such as semi-fowlers are not very usable (not really accepted for use). Furthermore, there is an issue of different interpretations of what this is.
Change spelling of foetus to fetus x2foetus should be fetusfoetus should be fetus
Misspelled termMisspelled termsinglemasked should be single-masked
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misspellmisspellcorporus should be corpus I
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capitalize proper namePascalschange pascals to Pascals I
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Definition misspellBritish spellingrepolarisation should be repolarization
capitalize proper namecapitalize proper namecapitalize Siemens in definition
capitalize proper namecapitalize proper name -3capitalize Siemens in definition
capitalize proper namecapitalize proper name-2capitalize Siemens in definition
proper name needs to be capitalized - Henry and Weber in definitionproper name needs capitalizationcapitalize Weber in definition
capitalize proper name 4capitalize proper name - 4capitalize Kelvin in definition
change British spellingchange British spellingchange foetus to fetus
change tesla to Teslachange tesla to Teslachange tesla to Tesla
change becquerel to Becquerelchange becquerel to Becquerelchange becquerel to Becquerel
change characterised to characterizedchange characterised to characterizedchange characterised to characterized
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change occuring to occurringchange occuring to occurringchange occuring to occurring
change stoping to stoppingchange stoping to stoppingchange stoping to stopping
change erthrocytes to erythrocyteschange erthrocytes to erythrocyteschange erthrocytes to erythrocytes
Consistency with other test codes related to urinary castsLBTESTAll lab test codes related to urinary casts are prefixed with CS with the exception of fine granular casts which has a test code of FGRANCS. For consistency reasons, please change this test code to CSFGRAN
HYPO is not specific enough.Change HYPO to HYPOCROMCDISC rules for representing HYPO are to use HPO. Please therefore consider change the new code to HPOCHROM instead of HYPOCROM
Consistency with literatureLACTICAC to LAFor Lactate Dehydrogenase we use LDH (the common abbreviation) as the test code. Can we consider changing LACTICAC to LA to keep a consistent approach?
For the urine Protein 24 hour test, we are running into the issue where the units of measure are not going through our conversion table because the urine Protein 24 Hr units (ie. mg/day) are different than the random urine Protein units (ie. mg/dL). The 24 Hour attribute can be captured in an additional field within the LB domain but this is not pulled into our conversion table. Can you please add Protein 24 Hr with the test code PROT24H.Add the lab test name Protein 24 Hr with the test code PROT24HFor the urine Protein 24 hour test, we are running into the issue where the units of measure are not going through our conversion table because the urine Protein 24 Hr units (ie. mg/day) are different than the random urine Protein units (ie. mg/dL). The 24 Hour attribute can be captured in an additional field within the LB domain but this is not pulled into our conversion table. Can you please add Protein 24 Hr with the test code PROT24H.
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The codelist is not estensible and we believe that there exists no equivalent CDISC term for the action taken of delaying a dose. We do not think delaying a dose is equivalent to interrupting the dose. We think interrupting the dose means to temporarily stop the dose, while delaying the dose means to alter the dosing schedule.Add DOSE DELAYED as a term to --ACN codelistSee justification for request
There is an error in the CDISC Synonym of C70526Error in CDISC SynonymThe CDISC Synonym for C70526 (GBq/ug) says "Gigabecquerel per microgram; MBq/ug, Megabecquerel per microgram". This is wrong. It should be "...; MBq/ng, Megabecquerel per nanogram"
There is an error in the CDISC Synonym of C70527Error in CDISC Synonym of C70527The CDISC Synonym for C70527 (GBq/mg) says "Gigabecquerel per Milligram; MBq/mg, Megabecquerel per Milligram". This is wrong. It should be "...; MBq/ug, Megabecquerel per Microgram"
The corresponding lbtest, lbtestcd are not in the SDTM control terminologyD-dimer, one of the fibrin degradation products, consists of variously sized pieces of crosslinked fibrin. It is produced only after a clot has formed and is in the process of being broken down.The fragments of the disintegrating fibrin in the clot are called fibrin degradation products (FDP). One of the FDPs produced is D-dimer, which consists of variously sized pieces of crosslinked fibrin. D-dimer is normally undetectable in the blood and is produced only after a clot has formed and is in the process of being broken down. Measurement of D-dimer can tell your doctor that something has increased above normal the body's clotting mechanisms.
The corresponding lbtest, lbtestcd are not in the SDTM control terminologyD-dimer, one of the fibrin degradation products, consists of variously sized pieces of crosslinked fibrin. It is produced only after a clot has formed and is in the process of being broken down.The fragments of the disintegrating fibrin in the clot are called fibrin degradation products (FDP). One of the FDPs produced is D-dimer, which consists of variously sized pieces of crosslinked fibrin. D-dimer is normally undetectable in the blood and is produced only after a clot has formed and is in the process of being broken down. Measurement of D-dimer can tell your doctor that something has increased above normal the body's clotting mechanisms.
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Common terminologyfor the all terms in the unit code list add synonym with mcg for uNumbers that I found 48152, 67306, 67327, 67394, 67396, 67397, 70523, 70526, 70530, 70581, 71205, 71210, 71211. I may have missed a few so please search the file to ensure we have all terms
Knee to Heel Length is used quite often for the infant studiesKnee to Heel Length is used quite often for the infant studiesKnee to Heel Length is used quite often for the infant studies
Partial pressure of carbon dioxidePartial pressure of carbon dioxidePartial pressure of carbon dioxide
Oxygen, partial pressureOxygen, partial pressureOxygen, partial pressure
Issues to map existing company country list against SDTM COUNTRY codelist. SDTM-COUNTRY codelist does not contain all ISO3166-1 alpha-3 country codes. However it is defined as not being extensibleSDTM-COUNTRY codelist does not contain all ISO3166-1 alpha-3 country codes.As far as I understand the current published CDISC COUNTRY codelist uses (such as HL7) the ISO3166-1 alpha-3 country codelist. Additionally it is defined to be not extensible. However the published CDISC COUNTRY codelist does (for whatever reason) not contain all elements of the ISO3166-1 alpha-3. E.g. the following elements of ISO3166-1 alpha-3 are missing: IMN = Isle of Man; BML = Saint Barthelemy; MAF = Saint Martin. And two elements do have a different three letter code: Jersey = JEY in ISO3166 and JRE in CDISC; Serbia = SRB in ISO3166 and SCG in CDISC. All in all ISO3166 has never been stable and will not be stable over time. So I think it does not make sense to define a "non extensible" codelist. Why not simply refer to the current version of ISO3166? They have a process in place how to accomodate the inevitable changes in the list of countries on earth.
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We capture LBTOXGR values of 0 to equate to Normal. We do not wish to set this value to missing because missing is used when the values or normal ranges are missing.We capture LBTOXGR values of 0 to equate to Normal. We do not wish to set this value to missing because missing is used when the values or normal ranges are missing.We capture LBTOXGR values of 0 to equate to Normal. We do not wish to set this value to missing because missing is used when the values or normal ranges are missing.
Only international unit terms are available in the CDISC UNIT terms list: Unit IU/L, Unit IU/mL, Unit IU/kg, Unit IU/mg, Unit IU/g. The symbol IU is reserved for WHO International biological reference preparations (http://www.who.int/biologicals/reference_preparations/en/). This applies only for the parameters as listed in the PDF document from WHO. In order to represent original and standard enzyme activities (because none of the common enzym reference preparation ist listed in this document) in a correct unit the addition of the following terms would be needed: Unit U/L, Unit U/mL, Unit U/kg, Unit U/mg, Unit U/g. In this context the definition of "IU" should be re-visited, since the example mentiones enzymes which seems misleading.U/L and other units needed beside IU/LOnly for the LB paramters where the WHO International Biological Reference Preparations existed as listed in the WHO document the "IU" can be used: http://www.who.int/bloodproducts/catalogue/bpromay06.pdf. In this list no common enzymes are listed e.g. ALP, ALT, AMYLASE, AST. Using for these paramters e.g. IU/L would not be corrected because there is no WHO reference preparation published. However, since catal (the SI unit) is not commonly used as standard representation it would be very good to be able to present enzym activities with a correct unit.
Standard measure of visceral obesity (size of one's belly).SAD - Sagittal Abdominal Diameter is a standard measure of visceral obesity (size of one's belly).SAD - Sagittal Abdominal Diameter is a standard measure of visceral obesity (size of one's belly).
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An example is an oncology trial where surgery is added on to a chemotherapy regimen for one Arm. In this case, surgery was the ADDON (ADDON = Y) and EXISTRT was the chemotherapy regimen.New TSPARMCD for EXISTRT (Existing Treatment)EXISTRT = Existing Treatment; An example is an oncology trial where surgery is added on to a chemotherapy regimen for one Arm. In this case, surgery was the ADDON (ADDON = Y) and EXISTRT was the chemotherapy regimen.
Existing Treatment (TSPARM) for EXISTRT (TSPARMCD). An example is an oncology trial where surgery is added on to a chemotherapy regimen for one Arm. In this case, surgery was the ADDON (ADDON = Y) and EXISTRT was the chemotherapy regimen. TSPARMCD EXISTRT was also requested on July 16, 2009.Existing Treatment (TSPARM) for EXISTRT (TSPARMCD)Existing Treatment (TSPARM) for EXISTRT (TSPARMCD). An example is an oncology trial where surgery is added on to a chemotherapy regimen for one Arm. In this case, surgery was the ADDON (ADDON = Y) and EXISTRT was the chemotherapy regimen. TSPARMCD EXISTRT was also requested on July 16, 2009.
New Term for both TSPARMCD (TRT) and TSPARM (Name of Treatment) requested. In the SDTMIG v3.1.2 implementation guide on page 282.New TSPARMCD = TRT for "Name of Treatment"New Term for both TSPARMCD (TRT) and TSPARM (Name of Treatment) requested. In the SDTMIG v3.1.2 implementation guide on page 282.
New Term for both TSPARMCD (TRT) and TSPARM (Name of Treatment) requested. In the SDTMIG v3.1.2 implementation guide on page 282.Add TSPARM (Name of Treatment)New Term for both TSPARMCD (TRT) and TSPARM (Name of Treatment) requested. In the SDTMIG v3.1.2 implementation guide on page 282.
New Term for both TSPARMCD (OBJ) and TSPARM (OBJECTIVE) requested to be added. Have situation of a protocol that only lists objectives and does not indicate whether they are Primary or Secondary so need a TSPARM/TSPARMCD to cover this.New Term TSPARMCD = OBJNew Term for both TSPARMCD (OBJ) and TSPARM (OBJECTIVE) requested to be added. Have situation of a protocol that only lists objectives and does not indicate whether they are Primary or Secondary so need a TSPARM/TSPARMCD to cover this.
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New Term for both TSPARMCD (OBJ) and TSPARM (OBJECTIVE) requested to be added. Have situation of a protocol that only lists objectives and does not indicate whether they are Primary or Secondary so need a TSPARM/TSPARMCD to cover this.New Term TSPARM = OBJECTIVENew Term for both TSPARMCD (OBJ) and TSPARM (OBJECTIVE) requested to be added. Have situation of a protocol that only lists objectives and does not indicate whether they are Primary or Secondary so need a TSPARM/TSPARMCD to cover this.
Grade 0 Adverse Event:No Adverse Event(Synonym). In addition to the five grades for describibg adverse events, this term also exists in NCI Common Terminology Criteria for Adverse Events v4.0.Please refer to the owl file at http://evs.nci.nih.gov/ftp1/CTCAE. New term definitions exist for grade terms which were provided by the EVS group at NCI, in CTCAE v4.0.New term request and request for change in definition. Comment Posted by submitter 2009-07-28 13:15 Change 'CTCAE' to 'CTCAE v4.0'The definition of the following terms in NCI Common Terminology Criteria for Adverse Events v4.0 are as follows: Codelist Code C66784 CTCAE Code E1005 CTCAE Definition An adverse event that is asymptomatic; or involves mild or minor symptoms; or is of marginal clinical relevance; or consists of clinical or diagnostic observations alone; or for which intervention is not indicated; or for which only non-prescription intervention is indicated. Codelist Code C66784 CTCAE Code E1006 CTCAE Definition An adverse event for which only minimal, local, or noninvasive intervention (e.g. packing, cautery) is indicated; or that limits instrumental activities of daily living (ADLs, e.g., shopping, laundry, transportation, or ability to conduct finances). Codelist Code C66784CTCAE Code E1007 CTCAE Definition An adverse event that is medically significant but not life-threatening; or for which inpatient care or prolongation of hospitalization are indicated; or that is an important me ical event that does not result in hospitalization, but may jeopardize the patient or may require intervention either to prevent hospitalization, to prevent the AE from becoming life-threatening or causing death; or that is disabling; or that results in persistent or significant disability, incapacity, or limitation of self care activities of daily living (ADLs, getting in and out of bed, dressing, eating, getting around inside, bathing, or using the toilet). Codelist Code C66784 CTCAE Code E1008 CTCAE Definition An adverse event that has life-threatening consequences; for which urgent intervention is indicated; that puts the patient is at risk of death at the time of the
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The current codelist description is "The name of a code list that contains terms that reference timepoints within and without a defined time period." I propose changing it to "The relative relationship of a timepoint to a reference timepoint." The current wording is somewhat awkward and confusing.Modify description of STENRF codelistThe current codelist description is "The name of a code list that contains terms that reference timepoints within and without a defined time period." I propose changing it to "The relative relationship of a timepoint to a reference timepoint."
Action taken with treatment can be for multiple treatments (sometimes there is more than one study drug). Then we would QNAM = AEACNR1-n where n is the number of study drugs, QLABEL is Reported Action Taken with <Drug>.MULTIPLE value proposed to deal iwth actions taken with multiple study drugsAction taken with treatment can be for multiple treatments (sometimes there is more than one study drug). Then we would QNAM = AEACNR1-n where n is the number of study drugs, QLABEL is Reported Action Taken with <Drug>.
For oncology trials, an action taken is often to decrease the infusion rate. This is not the same as reducing the dose, as often the total dose received will be the same, it is the administration interval that is lengthened by decreasing infusion rate.Additional action taken with study drug to reflect infusion rateFor oncology trials, an action taken is often to decrease the infusion rate. This is not the same as reducing the dose, as often the total dose received will be the same, it is the administration interval that is lengthened by decreasing infusion rate.
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In the codelist LBTESTCD (C65047) there are a number of codes for cell counts of all kinds of specific cell types (The NCI Preferred Term usually is "XXX Count"). The CDISC definition however uses three different wordings: 1) "A measurement of the XXX per unit of a biological specimen." (e.g. MONO) 2) "A measurement of the XXX in a biological specimen." (e.g. BLAST) 3) "A count of the XXX per unit of a biological specimen." (e.g. CD3). I would prefer to have consistently wording 1).Inconsistent CDISC definition for cell countsIn the codelist LBTESTCD (C65047) there are a number of codes for cell counts of all kinds of specific cell types (The NCI Preferred Term usually is "XXX Count"). The CDISC definition however uses three different wordings: 1) "A measurement of the XXX per unit of a biological specimen." (e.g. MONO) 2) "A measurement of the XXX in a biological specimen." (e.g. BLAST) 3) "A count of the XXX per unit of a biological specimen." (e.g. CD3). I would prefer to have consistently wording 1).
potentially missing codeNew Term needed for Total BilirubinIn the LBTESTCD codelist, there are codes for Bilirubin, Direct Bilirubin and Indirect Bilirubin. However I do not see a code for Total Bilirubin.
There are duplicates for Code, Codelist Code and Codelist name in EVALDuplicates for Code, Codelist Code and Codelist name in EVALThere are duplicates for Code, Codelist Code and Codelist name in EVAL. C42708 C78735 Evaluator CHILD CHILD A son or a daughter. C42708 C78735 Evaluator PARENT PARENT A mother or a father.
The terms Q.A.M. (every day before noon) and Q.P.M. (every day after noon) are missing from the FREQ codelist (C71113)Q.A.M. and Q.P.M. missing from FREQ codelistThe terms Q.A.M. (every day before noon) and Q.P.M. (every day after noon) are missing from the FREQ codelist (C71113)
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The reason why we want to add 'Stabilization' is to comply with regulatory requirements. An AE has to be followed until resolution or stabilization. With the current codelist we only know whether the AE is recovered or not recovered. Stabilization could apply to any diagnosis of chronic diseases of conditions (present before or starting during the course of the study) that are not curable/not expected to recover.The reason why we want to add 'Stabilization' is to comply with regulatory requirements. An AE has to be followed until resolution or stabilization.The reason why we want to add 'Stabilization' is to comply with regulatory requirements. An AE has to be followed until resolution or stabilization. With the current codelist we only know whether the AE is recovered or not recovered. Stabilization could apply to any diagnosis of chronic diseases of conditions (present before or starting during the course of the study) that are not curable/not expected to recover.
The definition for transverse liver fissure is in the liver fissure concept. Which concept does CDSIC want, so we can move the correct data into the correct concept?def in wrong placethe definition for transverse liver fissure is in the liver fissure concept. Which concept does CDSIC want, so we can move the correct data into the correct concept?
This concept is currently not captured in the Lab Terminology.Addition of term 'Cortisol, Free' to LBTESTListed are links to information regarding the test: Cortisol, Free; ARUP: http://www.aruplab.com/guides/ug/tests/0098391.jsp; Mayo: http://www.mayomedicallaboratories.com/test-catalog/Overview/91644; QUEST: http://www.questdiagnostics.com/hcp/testmenu/jsp/showTestMenu.jsp?fn=21469P.html&labCode=SJC;
Addition of Test code to go with the request to add the new term Cortisol, FreeAddition of 'CORTISLF' to LBTESTCDAddition of test code 'CORTISLF' to go with the request to add the new term 'Cortisol, Free'
Add a synonym for clarification of termAdd synonym to the LBTEST term 'Cortisol'Addition of the synonym 'Total Cortisol' to the existing LBTEST term 'Cortisol' for further clarification.
Add cm3 as a synonym of mL C28254Add cm3 as a synonym of mL C28254Add cm3 as a synonym of mL C28254
IIIWould you please add OTHER as an allowable value for the EGSTRESC variable within the ECG Result Codelist contained within the SDTM Terminology spreadsheet? By doing this, it will enable an easier record linking capability between the EG and SUPPQUAL datasets.Addition of OTHER as an allowable value for the EGSTRESC variableWould you please add OTHER as an allowable value for the EGSTRESC variable within the ECG Result Codelist contained within the SDTM Terminology spreadsheet? By doing this, it will enable an easier record linking capability between the EG and SUPPQUAL datasets.
Status
Open ### 25639 Merck
Open ### 25640 Merck
Open ### 25641 Merck
Open ### 25642 Merck
Open ### 25750
Open ### 25942 CDISC
Open ### 25943 Merck
Open ### 25948 Merck
Open ### 25950 Merck
Open ### 25952 Merck
Open ### 25953 Merck
Date of Submissio
nRequest
CodeSubmitter
NameSubmitter Affiliation
Submitter E-mail
Request Type
CDISC Codelist
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Omundsen, Erica
Not Provided
Not Provided
Create New Term
SDTM-LBTESTCD
Facile, Rhonda
Create New Term
SDTM-LOC
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Allen, Laura
Create New Term
SDTM-LBTEST
Open ### 25954 Merck
Open ### 25955 Merck
Open ### 25956 Merck
Open ### 25999 Merck
Open ### 26005 Merck
Open ### 26006 Merck
Open ### 26007 Merck
Open ### 26009 Merck
Open ### 26013 Merck
Allen, Laura
Create New Term
SDTM-LBTESTCD
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Open ### 26014 Merck
Open ### 26016 Merck
Open ### 26018 Merck
Open ### 26019 Merck
Open ### 26119 Merck
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
ONeill, Debra
Create New Term
SDTM-LBTEST
ONeill, Debra
Create New Term
SDTM-LBTESTCD
ONeill, Debra
Modify Existing Term
SDTM-LBTEST
Open ### 26291
Closed ### 26342
Open ### 26382 IPSEN None
Lenzen, Mary
Octagon Research Solutions
Modify Existing Term
SDTM-SKINCLAS
Wilden, Holger
BAYER VITAL GmbH, Leverkusen, Germany
Modify Existing Term
SDTM-ETHNIC
Campain-Teulon Elis
Create New Term
Open ### 26544 FibroGen
Open ### 26620 Merck
Open ### 26621 Merck
Open ### 26742
Closed ### 27067
Open ### 27068
Open ### 27070
Omundsen, Erica
Create New Term
SDTM-LBTESTCD
ONeill, Debra
Create New Term
SDTM-LBTEST
ONeill, Debra
Create New Term
SDTM-LBTESTCD
Not Provided
Not Provided
Not Provided
Create New Term
SDTM-LBTEST
Erin Muhlbradt
Lockheed Martin
[email protected] Existing Term
SDTM-MICROORG
Erin Muhlbradt
Lockheed Martin
[email protected] Existing Term
SDTM-MICROORG
Erin Muhlbradt
Lockheed Martin
[email protected] Existing Term
SDTM-MICROORG
Open ### 27125 J&J
Open ### 27186 Merck
Open ### 27188 Merck
Open ### 27189 Merck
Open ### 27190 Merck
Open ### 27221
Open ### 27229 Merck
Open ### 27230 Merck
Pemble, Nik
Modify Existing Term
SDTM-LBTESTCD
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Mary Lenzen
Octagon Research Solutions
[email protected] Existing Term
SDTM-TSPARMCD
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Open ### 27336 Merck
Open ### 27337 Merck
Open ### 28246
Open ### 28340
Open ### 28341
Open ### 28342
Open ### 28343
Open ### 28658
Chris Tolk
CDISC
Open ### 28691
Chris Tolk
CDISC
Open ### 28705 Merck
Open ### 28792
Allen, Laura
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Linda Pedersen
Astellas Pharma Global Development, Inc.
[email protected] Existing Term
SDTM-LBTEST
Tobias Hermes
PAREXEL International GmbH
[email protected] New Term
SDTM-LBTESTCD
Tobias Hermes
PAREXEL International GmbH
[email protected] New Term
SDTM-LBTESTCD
Tobias Hermes
PAREXEL International GmbH
[email protected] New Term
SDTM-LBTESTCD
Tobias Hermes
PAREXEL International GmbH
[email protected] New Term
SDTM-LBTESTCD
Modify Existing Term
SDTM-LBTESTCD
Modify Existing Term
SDTM-LBTEST
Dirk Van Krunckelsven
Modify Existing Term
SDTM-DOMAIN
Anna Pron-Zwick
Astra Zeneca anna.pro
Create New Term
SDTM-SPECTYPE
Open ### 28862 Quintiles
NoneOpen ### 28863 Amgen
Open ### 28927 Quintiles
Open ### 28937 Quintiles
Open ### 28983 GSK
OtherOpen ### 28984 GSK
OtherOpen ### 28985 GSK
Other NoneOpen ### 28986 GSK
Other NoneOpen ### 28987 GSK
OtherOpen ### 28988 GSK
OtherOpen ### 28989 GSK
OtherOpen ### 28990 GSK
OtherOpen ### 28991 GSK
Estrelita Janse van Rensburg
SDTM-LBTEST
Sophia Paterakis
Create New Term
SDTM-FREQ
Dianne Weatherall
Create New Term
SDTM-FRM
Dianne Weatherall
Create New Term
SDTM-ACN
Claire West
SDTM-LBTESTCD
Claire West
SDTM-LBTESTCD
Claire West
Claire West
Claire West
SDTM-LBTESTCD
Claire West
SDTM-LBTESTCD
Claire West
SDTM-LBTESTCD
Claire West
SDTM-LBTESTCD
Claire West
Modify Existing Term
SDTM-LBTESTCD
Open ### 28992 GSK
Open ### 29070
Open ### 29077
Open ### 29078
Open ### 29140
OtherOpen ### 29241
Other NoneOpen ### 29614 Almirall
NEWOpen ### 29697
Claire West
Modify Existing Term
SDTM-LBTESTCD
Nik Pemble
Johnson and Johson
Modify Existing Term
SDTM-LBTEST
Erin Muhlbradt
Lockheed Martin
Modify Existing Term
SDTM-PKUNIT
Erin Muhlbradt
Lockheed Martin
Modify Existing Term
SDTM-PKUNIT
Erin Muhlbradt
Lockheed Martin
SDTM-PKUNIT
Erin Muhlbradt
Lockheed Martin
Manuel Horas
Create New Codelist
Tore Haglund
AstraZeneca
Modify Existing Term
SDTM-SPECTYPE
Open ### 29698 None
Open ### 29708
GSKOpen ### 29709
GSKOpen ### 29710
GSKOpen ### 29711
GSKOpen ### 29712
GSKOpen ### 29713
GSKOpen ### 29726
GSKOpen ### 29727
GSKOpen ### 29728
GSKOpen ### 29729
GSKOpen ### 29730
GSKOpen ### 29731
GSK
Manuel Horas Laborator
ies ALmirall
SDTM-PKUNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Open ### 29732
GSKOpen ### 29733
GSKOpen ### 29734
GSKOpen ### 29735
GSK
Other
Open ### 29736
GSKOpen ### 29737
GSKOpen ### 29738
GSKOpen ### 29739
GSKOpen ### 29740
GSKOpen ### 29741
GSKOpen ### 29742
GSK
Other
Open ### 29743
Open ### 29805
CRO
Claire West
Modify Existing Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Modify Existing Term
SDTM-UNIT
Claire West
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Modify Existing Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
Create New Term
SDTM-UNIT
Claire West
SDTM-UNIT
Van Krunckelsven Dirk
Merck Serono S.A.
Modify Existing Term
SDTM-LBTESTCD
Hector Robertson
Create New Codelist
SDTM-LBTEST
Open ### 29816
Open ### 29817
J&JOpen ### 29895
Open ### 29898
Open ### 29899
Open ### 29900
Open ### 29904
Open ### 29912
Matthew Peck
Genzyme Corporation
Create New Term
SDTM-ACN
Nik Pemble
Modify Existing Term
SDTM-LBTEST
Audrey Walker Charles
River Laboratories
Modify Existing Term
SDTM-UNIT
Audrey Walker Charles
River Laboratories
Modify Existing Term
SDTM-UNIT
Audrey Walker Charles
River Laboratories
Modify Existing Term
SDTM-UNIT
Audrey Walker Charles
River Laboratories
Create New Term
SDTM-UNIT
Audrey Walker
Charles River Laboratories
Modify Existing Term
SDTM-UNIT
Monica Mattson
Celgene Corporation
Modify Existing Term
SDTM-NCOMPLT
Open ### 29960
Open ### 30005 Chris Tolk
CDISCOpen ### 30055
Open ### 30081
GSKOpen ### 30096
J&J
Other
Open ### 30098
LMCO
None
Open ### 30117 None
Open ### 30166 Chris Tolk
CDISC
Carol Vaughn
Sanofi-Aventis
Modify Existing Term
SDTM-SOC
Modify Existing Term
SDTM-TSPARM
Albert Chau
Antisoma Research Limited
Modify Existing Term
SDTM-LBTEST
claire west
Create New Term
SDTM-UNIT
Gail Stoner
SDTM-LBTESTCD
Erin Muhlbradt
Modify Existing Term
Monica Mattson
Celgene Corporation
Create New Term
Modify Existing Term
SDTM-VSTEST
Open ### 30217
LMCO
Other None
Open ### 30218
LMCO
Other None
Open ### 30274
Open ### 30302
Open ### 30303
Open ### 30358
Covance
Erin Muhlbradt
Erin Muhlbradt
Anna Pron-Zwick
AstraZeneca Pharmaceuticals
Create New Term
SDTM-LOC
campain-teulon
PHARMACEUTICAL COMPANY
Create New Term
SDTM-LOC
Randall Austin
GlaxoSmithKline
Modify Existing Term
SDTM-TSPARM
John Swithenbank
Create New Term
SDTM-FREQ
Open ### 30359
CovanceOpen ### 30360
CovanceOpen ### 30361
Covance
John Swithenbank
Create New Term
SDTM-LBTEST
John Swithenbank
Create New Term
SDTM-FREQ
John Swithenbank
Create New Term
SDTM-LBTEST
Anti-Single Stranded DNA
ASSDNA
Influenza A Virus PCR
INFAPCR
Bone Specific Alkaline Phosphatase
Anatomical Location/Blood Pressure/ ANKLE
Type I Myeloblasts
Add SDTM - LBTESTCD of BLSTMY1
Type II Myeloblasts
BLSTMY2
Type III Myeloblasts
New Term or Codelist/Existing Term or Code Number
BLSTMY3
Myeloid/Erythroid Ratio
MERATIO
Chlamydia Pneumoniae IgM Antibody
CPIGMAB
Legionella Pneumophila IgG Antibody
LPIGGAB
Legionella Pneumophila IgM Antibody
LPIGMAB
Legionella Pneumophila IgG and IgM Ab
LPIGGMAB
Antimyeloperoxidase Antibody
Acetylcholine
Addition of test code 'ANTIMPAB' to go with new term request 'Antimyeloperoxidase Antibody'
SKINCLAS (C76351)
ECG RESULT
C66790, there should only be one codelist name for this codelist
Bone Specific Alkaline Phosphatase
D-Dimer
DDIMER
Acetoacetate or Acetoacetic acid
Remove the word 'SPECIES' from all genus-level CDISC PTs
Change NCI C-code of CDISC PT GRAM-POSITIVE BACILLUS from C86423 to C62589
Remove Mycobacterium fortuitum subsp. fortuitum as a synonym of Mycobacterium fortuitum C86538
Hepatitis G RNA
HGVRNA
Influenza A Virus H1N1 PCR
INFAH1N1
Mycobacterium Tuberculosis QFT
MTUBEQFT
EPISQTCE and Squamous Transitional Epithelial Cells
2 terms for TSPARMCD/TSPARM that seem to be exactly the same - CURTRT (Current Treatment) and EXISTRT (Existing Treatment). Please delete CURTRT
CPIGAGAB
"FASTING BLOOD GLUCOSE (SST)"
"Bilirubin in Urine" and "Blood in Urine"
Nasopharyngeal
Chlamydia Pneumoniae IgA and IgG Ab
Vascular Epithelial Growth Factor please correct to the most common test name Vascular Endothelial Growth Factor
"Crystals: Amorphous phosphates", "Crystals: Amorphous urates" and "Crystals: Amorphous debris"
"Erythrocytes; Red Blood Cells in Urine" and "Leukocytes; White Blood Cells in Urine"
C74724, c74725, c74726, c74727 HAVPCR, HBVPCR, HCVPCR, HIVPCR - remove PCR, this is a method
C54431 add synonym of microalbumin to albumin
C49610 C66734 Domain Abbreviation SC Subject Characteristics The subject characteristics domain is for data not collected in other domains that is subject-related. Examples: subject initials, other race details, eye color, childbeari
Hepatits C virus antibodies
OCCASIONAL
TABLET, OVER ENCAPSULATED
IGG Immunoglobulin G
Add new term DOSE ADJUSTED or allow the codelist to be extensible
AMA Antimitochondrial Antibodies
BNPPRO ProB-type Natriuretic Peptide
CTOT Complement Total
CTXI Type I Collagen C-Telopeptides
HTPHAB Heterophile Antibodies
VCAM1 Vascular Cell Adhesion Molecule 1
PO2 Partial Pressure Oxygen
VITD Vitamin D
FDP Fibrin Degradation Products
C85663 L/kg/day
Remove C85713 mL/g/s from PKUNIT codelist
SC codelist (Subject Characteristics)Code C77666 = EMESIS should be VOMIT
LBTESTCD=PT LBTEST=Prothrombin Time. The team should reconsider the definition. Currently it indicates that it can be expressed in units of time or percentage activity. We can only have one unit type per test code.
C85659 Liter per Gram per Minute; remove synonym uL/ug/s
Modify explanation of NCIt PT column on SDTM/CDASH/ADaM spreadsheets in ReadMe tab
/h
Code: 1 ; Label: Proportion of 1
Code: CELLS/F; Label: Cells per field
Code: TITER/TITRE; Label: Titer/Titre
Code: %O; Label: Promille (per 1000 RBC)
Code: EIA; Label: Enzyme Immunoassay Value
Code: EU/dL; Label: Ehrlich units per decilitre
Code: um3; Label: Cubic micrometre
Code: fl; Label: Femtolitre
Code: %TL CK; Label: Percentage of total creatine kinase
Code: CELLS/HPF; Label: Cells per high power field
Is there a principle about coding non-unit words. These include the following: ACTUATION
I have 3 codes that make use of the term Femtomole...
g% - Grams percent; mg% - Miligrams percent
I have a code of CTC/7.5mL.
Not Sure
Code: mg/mg creat; Label: Milligrams per gram of Creatinine
Can you please review and comment on the following synonym suggestions:
Can you please confirm the use of k vs thousand.
We use GI/L (giga/Litre) and TI/L (Tera/Litre) a lot. Should these codes remain GI/L and TI/L or be expanded to Giga/L and Tera/L?
In the UNIT terminology for the unit ug/m3, the definition refers to synonyms. Can these please be added to the Synonym column? i.e. ng/L and pg/mL
Case is a constant question e.g. FEU (Fibrinogen equivalent units) I assume this should be uppercase based on CFU (Colony Forming Units)?
Can I use MESF as an industry abbreviation for molecules of equivalent soluble fluorochromes? e.g. MESF/cell (or CELL)?
I have a unit of Median Fluorescence. Should I use MFI or spell the unit in its entirety in lowercase?
Would circulating endothelial cells be expressed as CEC since this appears to be an industry std abbreviation
Actually a mixture between new term request and modify term request...
Treatment Adjusted
The lab test name associated with VEGF I think is not correct. It currently reads VASCULAR EPITHELIAL GROWTH FACTOR and I think it should read VASCULAR ENDOTHELIAL GROWTH FACTOR
C42576 C71620 Unit kg/m3
C64572 C71620 Unit g/m3
C67255 C77528 UNIT thous/uL
C67308 C77528 UNIT mill/uL million per microliter
C67327 C71620 Unit ug/m3
Current codelist value WITHDRAWAL BY SUBJECT. Suggest enhance to WITHDRAWAL OF INFORMED CONSENT BY SUBJECT to avoid possible confusion if subject withdraws , for example, from one phase of the study (treatment phase) but allows data collection for follow-
Change terms to sentence case
Platelet should be changed to Platelets
10^3/uL
EPISQCE
CDASH Terminology - C78424 codelist code
Change C20587 from Age Group to Age Span to match the text in C67152 and Age Span code list.
In SDTM-PKPARM: Request addition of AUC Infinity Obs Norm by Dose to allow for dose-normalization of AUC extrapolated to infinity.
C25298 C66741 Vital Signs Test Code SYSBP Systolic Blood Should read 'Systolic Blood Pressure'
Changes to ADaM Terminology spreadsheet
Changes to existing CDASH CT Spreadsheet format
Cardiovascular System; Endocrine System; Exocrine System; Immune System; Hematopoietic and Lymphatic System; Musculoskeletal System; Nervous System; Respiratory System; Integumentary System; Reproductive System
CEREBRAL CORTICAL; CEREBRAL SUBCORTICAL; BRAINSTEM
modify CDISC definition where TSPARM=Planned number of subjects and TSPARMCD=PLANSUB
QHS - Every Night; MANE - In the Morning; NOCTE - At night
21 days with 7 day break
LBTEST = Immunoglobulin D; LBTESTCD = IGD
Kappa Free Light Chain; Lambda Free Light Chain; Free Kappa/Free Lambda Ratio; M-Protein; Quantitative immunoglobulins and IgG, IgM, IgA, IgD
Detailed Description
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Change Type
This concept is not in the dictionary.; addition of new term; addition of new term
; Addition of new test code for Anti-Single Stranded DNA; Addition of new test code for Anti-Single Stranded DNA
This concept is not in the dictionary.; Addition of new term; Addition of new term.
This concept is not int he dictionary.; Addition of new test code for Influenza A Virus PCR; Addition of new test code for Influenza A Virus PCR.
I do not see a code and decode for Bone Specific Alkaline Phosphatase.; Bone Specific Alkaline Phosphatase; New code is needed for new term Bone Specific Alkaline Phosphatase
The code list is anatomical location. So the measurement would be blood pressure and the anatomical location would be ankle.; Add ANKLE as a location for taking blood pressure.; See summary.
The lab term 'Type I Myeloblasts' is not in the CDISC lab tests dictionary.; Add a new SDTM - LBTEST of Type I Myeloblasts; Add a new SDTM - LBTEST of Type I Myeloblasts
The SDTM - LBTESTCD of BLSTMY1 is not in the CDISC lab tests dictionary.; Add a SDTM - LBTESTCD of BLSTMY1 for the test 'Type I Myeloblasts'; Add a SDTM - LBTESTCD of BLSTMY1 for the test 'Type I Myeloblasts'
The lab term (LBTEST) of Type II Myeloblasts is not in the CDISC lab tests dictionary.; Add a new SDTM - LBTEST of Type II Myeloblasts; Add a new SDTM - LBTEST of Type II Myeloblasts
The LBTESTCD of BLSTMY2 is not in the CDISC lab tests dictionary.; Add a new SDTM - LBTESTCD of BLSTMY2 for Type II Myeloblasts; Add a new SDTM - LBTESTCD of BLSTMY2 for Type II Myeloblasts
Justification for Change Request: The lab term (LBTEST) of Type III Myeloblasts is not in the CDISC lab tests dictionary.; Add a new SDTM - LBTEST of Type III Myeloblasts; Add a new SDTM - LBTEST of Type III Myeloblasts
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The lab test code (LBTESTCD) of BLSTMY3 is not in the CDISC lab tests dictionary.; Add a new SDTM - LBTESTCD of BLSTMY3 for Type III Myeloblasts; Add a new SDTM - LBTESTCD of BLSTMY3 for Type III Myeloblasts
The lab term (LBTEST) of Myeloid/Erythroid Ratio is not in the CDISC lab test dictionary.; Add a new SDTM - LBTEST of Myeloid/Erythroid Ratio; Add a new SDTM - LBTEST of Myeloid/Erythroid Ratio
The lab test code (LBTESTCD) of MERATIO is not in the CDISC lab test dictionary.; Add a new SDTM - LBTESTCD of MERATIO for Myeloid/Erythroid Ratio; Add a new SDTM - LBTESTCD of MERATIO for Myeloid/Erythroid Ratio
The lab term (LBTEST) of Chlamydia Pneumoniae IgM Antibodyis not in teh CDISC dictionary.; Add a new SDTM-LBTEST of Chlamydia Pneumoniae IgM Antibody; Add a new SDTM-LBTEST of Chlamydia Pneumoniae IgM Antibody. Reference: http://www.aruplab.com/
The lab test code (LBTESTCD) of CPIGMAB is not int eh CDSIC dictionary.; Add a new SDTM-LBTESTCD of CPIGMAB for Chlamydia Pneumoniae IgM Antibody; Add a new SDTM-LBTESTCD of CPIGMAB for Chlamydia Pneumoniae IgM Antibody.
The lab term (LBTEST) of Legionella Pneumophila IgG Antibody is not in the CDISC dictionary.; Add a new SDTM-LBTEST of Legionella Pneumophila IgG Antibody; Add a new SDTM-LBTEST of Legionella Pneumophila IgG Antibody.
The lab test code (LBTESTCD) of LPIGGAB is not in the CDSIC dictionary.; Add a new SDTM - LBTESTCD of LPIGGAB for Legionella Pneumophila IgG Antibody; Add a new SDTM - LBTESTCD of LPIGGAB for Legionella Pneumophila IgG Antibody
The lab term (LBTEST) of Legionella Pneumophila IgM Antibody is not in the CDISC dictionary.; Add a new SDTM-LBTEST of Legionella Pneumophila IgM Antibody; Add a new SDTM-LBTEST of Legionella Pneumophila IgM Antibody. Reference: http://www.questdiagnostics.com/hcp/qtim/testMenuSearch.do
The lab test code (LBTESTCD) of LPIGMAB is not in the CDSIC dictionary.; Add a new SDTM - LBTESTCD of LPIGMAB for Legionella Pneumophila IgM Antibody; Add a new SDTM - LBTESTCD of LPIGMAB for Legionella Pneumophila IgM Antibody
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Justification for Change Request: The lab term (LBTEST) is not in the CDISC dictionary.; Add a new SDTM-LBTEST of Legionella Pneumophila IgG and IgM Ab; Add a new SDTM-LBTEST of Legionella Pneumophila IgG and IgM Ab. Reference: http://www.questdiagnostics.com/hcp/qtim/testMenuSearch.do
The lab test code of LPIGGMAB is not in the CDISC dictionary.; Add a new SDTM - LBTESTCD of LPIGGMAB for Legionella Pneumophila IgG and IgM Ab; Add a new SDTM - LBTESTCD of LPIGGMAB for Legionella Pneumophila IgG and IgM Ab
The lab term 'Antimyeloperoxidase Antibody' is not currently available in SDTM-LBTEST.; Addition of term 'Antimyeloperoxidase Antibody' to LBTEST; The term 'Antimyeloperoxidase Antibody' is not currently available in SDTM-LBTEST. "Antineutrophil cytoplasmic antibodies (ANCA) are autoantibodies directed against lysosomal enzymes of human neutrophils and monocytes. Myeloperoxidase (MPO) is the autoantigen most commonly responsible for ANCA reactivity that demonstrates the perinuclear pattern (P-ANCA)." Speciality Laboratories "Antineutrophil Cytoplasmic Autoantibodies" - see attached file. This test is available for testing from: ARUP Laboratories (http://www.aruplab.com/guides/ug/tests/2002068.jsp); Mayo Medical Laboratory (http://www.mayomedicallaboratories.com/test-catalog/Overview/80389); Quest Diagnostics (http://www.questdiagnostics.com/hcp/testmenu/jsp/showTestMenu.jsp?fn=70159X.html&labCode=SJC); Speciality Laboratories (http://www.specialtylabs.com/tests/details.asp?id=1866)
Addition of test code 'ANTIMPAB' to go with the request to add the new term 'Antimyeloperoxidase Antibody'; Addition of 'ANTIMPAB' to LBTESTCD; Addition of test code 'ANTIMPAB' to go with the request to add the new term 'Antimyeloperoxidase Antibody'
Addition of a synonym(s) for the term Acetylcholine for clarification; ;
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Below is a reference for the Fitzpatrick Classification SCale. Based on that, I expected the SKINCLAS (C76351) CDISC Submission Value to be I, II etc and not TYPE1, TYPE2 etc. http://dermatology.about.com/od/cosmeticprocedure/a/fitzpatrick.htm: Fitzpatrick Classification Scale: Skin Type Skin Color Characteristics: I White; very fair; red or blond hair; blue eyes; freckles Always burns, never tans; II White; fair; red or blond hair; blue, hazel, or green eyes Usually burns, tans with difficulty; III Cream white; fair with any eye or hair color; very common Sometimes mild burn, gradually tans; IV Brown; typical Mediterranean caucasian skin Rarely burns, tans with ease; V Dark Brown; mid-eastern skin types very rarely burns, tans very easily; VI Black Never burns, tans very easily; Fitzpatrick Classification Scale does not match with CDISC controlled terminology; Below is a reference for the Fitzpatrick Classification SCale. Based on that, I expected the SKINCLAS (C76351) CDISC Submission Value to be I, II etc and not TYPE1, TYPE2 etc. http://dermatology.about.com/od/cosmeticprocedure/a/fitzpatrick.htm: Fitzpatrick Classification Scale: Skin Type Skin Color Characteristics: I White; very fair; red or blond hair; blue eyes; freckles Always burns, never tans; II White; fair; red or blond hair; blue, hazel, or green eyes Usually burns, tans with difficulty; III Cream white; fair with any eye or hair color; very common Sometimes mild burn, gradually tans; IV Brown; typical Mediterranean caucasian skin Rarely burns, tans with ease; V Dark Brown; mid-eastern skin types very rarely burns, tans very easily
In the SDTM Terminology 2009-10-06 there are two codelist names for this codelist, "Ethnic Group" and "Patient Ethnic Group".; ;
New codes were requested by ECG vendor to code abnormalities; Request for new ECG results codes; EARLY R WAVE PROGRESSION; RSR’ OR QR PATTERN IN V1 SUGGESTS RIGHT VENTRICULAR DELAY; ELECTRONIC VENTRICULAR PACEMAKER; ELECTRONIC ATRIAL PACEMAKER; 2ND DEGREE A-V BLOCK (MOBITZ I); 2ND DEGREE A-V BLOCK (MOBITZ II); QTcB or QTcF Borderline Prolonged
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This is the correct mapping in our database. II
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We are unable to locate the corresponding term in either the SDTM-LBTESTCD or SDTM-LBTEST code lists for Bone Specific Alkaline Phosphatase.; new term needed in SDTM-LBTEST and SDTM-LBTESTCD CDISC Code Lists; This is a request to have a new term added to the SDTM-LBTEST and SDTM-LBTESTCD CDISC Code Lists for the lab test "Bone Specific Alkaline Phosphatase".
Concept of D-Dimer not currently available in CDISC; Addition of 'D-Dimer' to LBTEST; Please add the test 'D-Dimer' to the SDTM-LBTEST CDISC code list. This test is used to measure the cross-linked fibrin degradation product, D-dimer, in a biological specimen. References: ARUP: http://www.aruplab.com/guides/ug/tests/0030057.jsp; Quest: http://www.questdiagnostics.com/hcp/testmenu/jsp/showTestMenu.jsp?fn=32466P.html&labCode=SJC;
code addition (DDIMER) to go with request to add new term (D-Dimer); Addition of 'DDIMER' to LBTESTCD; Addition of the test code 'DDIMER' to go with the request to add the new term 'D-Dimer'.
Acetoacetate or Acetoacetic acid is not a part of LBTEST and LBTESTCD; Acetoacetate or Acetoacetic acid is not a part of LBTEST and LBTESTCD; Acetoacetate or Acetoacetic acid is not a part of LBTEST and LBTESTCD
Placing the word SPECIES in the CDISC PTs of these terms in the NCI Thesaurus directly contradicts the CDISC definition. This contradiction, besides being terminologically incorrect, causes problems when exporting our databases. We strongly recommend removing the word 'SPECIES' from the Genus level terms in the MICROORG codelist.
This is not really a synonym but more of a parent-child relationship
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EPISQTCE - This test code and related test name Squamous Transitional Epithelial Cells is an incorrect use of terminology; transitional epithelial cells are typically cells originating from the bladder whereas cells from the external urethra are typically coined squamous epithelial cells. These cells have different appearances based upon their origin. As an FYI Renal tubular cells originate in the kidney and is the third general group of epithelial cells found in urine
Add a new SDTM - LBTEST of Hepatitis G RNA. The lab term (LBTEST) Hepatitis G RNA is not in the CDISC dictionary. Add a new SDTM - LBTEST of Hepatitis G RNAReference: Specialty Laboratories
Add a new SDTM - LBTESTCD of HGVRNA for Hepatitis G RNA. The lab test code (LBTESTCD) of HGVRNAis not in the CDISC dictionary. Add a new SDTM - LBTESTCD of HGVRNA for Hepatitis G RNA.
Add a new SDTM - LBTEST of Influenza A Virus H1N1 PCR. The lab term (LBTEST) of Influenza A Virus H1N1 PCR is not in the CDISC dictionary. Add a new SDTM - LBTEST of Influenza A Virus H1N1 PCR. Reference: Quest Diagnostics
Add a new SDTM - LBTESTCD of INFAH1N1 for Influenza A Virus H1N1 PCR. The lab test code (LBTESTCD) of INFAH1N1 is not in the CDISC dictionary. Add a new SDTM - LBTESTCD of INFAH1N1 for Influenza A Virus H1N1 PCR.
I submitted the request to add EXISTRT (Existing Treatment) based on work done by the CDISC Trail Design Team. Do not why or who requested CURTRT but do not need both since they are redundant.
This term is not in the CDISC Dictionary. Definition: Identification of Mycobacterium tuberculosis in a biological specimen using the quantiFERON-TB Gold In Tube (QFT). QuantiFERON-TB Gold In Tube is a Cell Culture/Enzyme-Linked Immunosorbent assay specific for Mycobacterium tuberculosis, not nontuberculosis mycobacterium or the BCG vaccine.
This term is not in the CDISC Dictionary. Definition: Identification of Mycobacterium tuberculosis in a biological specimen using the quantiFERON-TB Gold In Tube (QFT). QuantiFERON-TB Gold In Tube is a Cell Culture/Enzyme-Linked Immunosorbent assay specific for Mycobacterium tuberculosis, not nontuberculosis mycobacterium or the BCG vaccine.
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Suggesting "FBG" III
Suggesting "CYAMPHOS", "CYAMURAT" and "CYAMDEBR" III
Suggesting "URBC" and "UWBC" III
Suggesting "UBILI" and "UBLOOD" III
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C54431 add synonym of microalbumin to albumin II
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The lab term (LBTEST) of Chlamydia Pneumoniae IgA and IgG Ab is not in the CDISC dictionary.
The lab code (LBTESTCD) of CPIGAGAB is not in the CDISC dictionary.
When doing some research to add this LBTEST to our own system we discovered that the most common name is Vascular Endothelial Growth Factor
C74724, c74725, c74726, c74727 HAVPCR, HBVPCR, HCVPCR, HIVPCR - remove PCR, this is a method
The description, example part seems to not accord with SDTM 3.1.2 where the race other is now captured on SUPPDM (personally I preffered SC for this as per SDTM IG 3.1.1, but it seems to have changed).
Please consider either adding Nasopharynx or Nasopharyngeal as a specimen type. Nasopharyngeal swabs are frequently used when testing for various viruses, e.g. Adenovirus, Rhinovirus, Influenza, etc.
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Is this the same as N-terminal pro-Brain Natriuretic Peptide? III
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Is this the same as Type I collagen X-linked C-telopeptide? III
Is this the same as Heterophile Antibody Mono screen? III
Is this the same as Soluble VCAM1? III
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The list that I saw contained the following name: Hepatitis C virus surface antibodies. The term "surface" should be removed since it is used with Hepatitis B virus.
This FREQ term is actually in the SDTM IG 3.1.2. We include this frequency in our CRFs (for SU cigarette smoking). Non of the existing terms for FREQ actually cover this.
We have a trial where tablets were over-encapsulated in order to blind the treatment taken. I could not match this to any existing terms, and would therefore like to request a new term for this.
I have a legacy study where the action taken = "Dose adjusted". This does not map to the SDTM terminology, and the codelist is not extensible.
Is this the same as Mitochondrial antibody? If so, can this be added as a synonym? Applies to LBTESTCD and LBTEST
Is this the same as Total Haemolytic Complement (CH50)?
We also have Partial Pressure of Arterial Oxygen - is this a new code or PO2 with 'Arterial' as location?
How do we differentiate from 1,25-Dihydroxy-Vitamin D? We have 2 Vitamin D tests: Calcidiol (inactive form) which is 25-Hydroxy-Vitamin D; Calcitriol (active form) which is1,25-Dihydroxy-Vitamin D
Can I question Gamma Globulin as a synonym: As per Wiki: The most significant gamma globulins are immunoglobulins ("Igs"), more commonly known as antibodies, although some Igs are not gamma globulins, and some gamma globulins are not Igs.
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Change c-code to C73755 II
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Can you please add Fibrinogen Degradation Products as a Synonym as I believe this is true based on research I've done. http://peir.path.uab.edu/coag/article_77.shtml
I suggest the team modifies the definition of PT to indicate that it is expressed in units of time and that they develop a new testcd, test name and definition (eg: PTACT or PTAT, Prothrombin Time Activity, and a suitable definition inidcating units expressed as a percentage of activity.
On term C85659 L/g/min, remove the synonym uL/ug/s from published CDISC terminology. Add uL/ug/min as a CDISC SY.
Term mL/g/s is a synonym of term C85664 L/kg/s in the PKUNIT codelist. Please keep L/kg/s as the CDISC PT. Synonyms are fine for C85664 and do not need to be altered.
This identifies the NCI preferred name for a term as identified in NCIt. **NOTE - This column designates the human readable, fully specified preferred term corresponding to the NCI c-code, and is especially helpful for searching NCIt to get the entire concept with links to all instances of the term.
In the last version of controlled terminology there is the codelist SCCD, but in my opinion we need also de codelist SC in order to have the meaning of the SCCD terms. i.e. in the CODE column this new codelist SC, have to have the same values than SCCD codelist terms. Example: in the codelist SCCD there is the value SALTYP (C74556) but there is no way to link with the appropriate value of this code. The solution I propose is the same you have already implemented in VSTEST and VSTESCD, LBTEST and LBTESTCD, EGTEST and EGTESTCD, DATEST and DATESTCD, TSPARM and TSPARMCD. If you decide implement this codelist in a future versionof controlled terminology, maybe you have to take into account that "SC" is included as a term for the codelist DOMAIN.
Emesis is "the act of vomiting", cannot be a specimen type. This should be VOMIT.
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Is this the same as ELISA unit? III
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Ia this valid or should it be converted to a litre equivalent? III
Used for mean corpuscle volume and mean platelet volume III
Fmol values used for MCV, MCH etc III
I think the use of this unit is very common for LAMZ PK parameter
Predominently used for WBC differentials, reticulocytes and Hematocrit. For WBC diffs, the data is converted to % by x100. For retics and hct, the SI is 1 (as per Quest central labs)
I have a couple of codes such as these where the vendor defines the percentage based on the reference test. I really need confirmation whether these are valid units, or whether the cod should just be % and leave the LBTESTCD/LBTEST to define the reference.
I have a number of units that begin with the words casts and cells e.g. CELLS/HPF and CASTS/UL. Can you tell me whether the word should be upper or lowercase and whether it should be singular or plural. i.e. cell/HPF, CELL/HPF, cells/HPF or CELLS/HPF or should the word be dropped entirely and just have a unit of /HPF or /LPF?
The unit for High Power Field is HPF. Would field be expressed as F or FIELD? F is the unit for Fahrenheit so I wasnt sure.
Will Titer be spelt TITER or TITRE? Is it an uppercase or lowercase code?
This has been used for a reticulocyte test where this was the original unit and was converted to '1' x 0.001
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g% - Is this a synonym for g/dL? mg% - is this a synonym for mg/dL?
If they are not synonyms can you please add them as new terms.
BILI, WBC, and other terms can exist for different types of samples: urin, haem, chem, etc. Would it make sense to create one item for each of these so that there is no confusion? I know that at the SDTM level there is a CATEGORY available, so that this can be split out, but upon constructing ADaMs in the BDS structure I run into issues here...
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If changed, please also update the definition III
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Some studies may not have all the details of how a dose was adjusted (up or down), just that it was adjusted. Also older studies that are completed but are being mapped to SDTM, will not have a one to one match if Dose Increased / Decreased was not collected, and Dose Adjusted was.
Please change the preferred term kg/m3 to g/L as this is the standard unit for Labs. Preferred term should be g/L.
Please change the CDISC preferred term of g/m3 to mg/L as this is standard throughout the industry. Change g/m3 to mg/L
Please change the CDISC preferred term thous/uL to 10^3/uL as this is standard throughout the industry. Change thous/uL to 10^3/uL.
Please consider changing the SEND CDISC preferred term for mill/uL to 10^6/uL as this is the industry standard. Add 10^6/uL to the SDTM UNIT codelist.
Please change the CDISC preferred unit ug/m3 to ng/L as this is the industry standard. We would also like this change for consistency with all the following preferred CDISC terms; There are currently:15 existing terms that end with '/L', including kg/L, ug/L, mol/L, mmol/L, nmol/L, pmol/L, and IU/L.22 terms that end with '/mL' rather than cm35 terms that end with '/uL' rather than mm3 (interestingly, 'uL' alone doesn't even seem to be in the list).3 terms that end in '/dL'
Current codelist value WITHDRAWAL BY SUBJECT. Suggest enhance to WITHDRAWAL OF INFORMED CONSENT BY SUBJECT to avoid possible confusion if subject withdraws , for example, from one phase of the study (treatment phase) but allows data collection for follow-up phase.
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"If the external reference for the controlled terminology is not in upper case then the data should conform to the case prescribed in the external reference (e.g., MedDRA and LOINC)." - MedDRA SOC terms are in sentence case.
This is one of numerous codes which are represented in this way using the '10 to the power of' format. Others include 10^2/uL, 10^3/mm3 up to 10^12/L. I'm looking for guidance on how to represent these data. Is 10^3/uL best expressed as Thou/uL, or k/uL or is 10^3/uL valid? This type of unit is typically used in relation to cells e.g. WBC differentials.
This is more of a question than a suggestion. The CDISC definition of most tests is "A measurement of ... in a biological specimen," but some tests a described in terms of a particular specimen such as "urine." We have a study where sputum cytology is being captured. An example of one of the tests is squamous epithelial cell count. The CDISC definition for EPISQCE indicates is "A measurement of the squamous epithelial cells present in a urine specimen." Do we need to request a new test code or is this test code appropriate for use in other biological specimens? Thanks.
Change C78424 to C78745 in column B to reflect correct codelist code subset.
This would also require the addition of a new code (eg, AUCIFOD) to the PKPARMCD codelist. This request was originated by a pharmacokineticist in my organization who saw that all other AUC parameters had values normalized to Dose except this one.
C25298 C66741 Vital Signs Test Code SYSBP Systolic Blood Should read 'Systolic Blood Pressure'
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needed to locate stroke III
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In order to further the requirements of the ODM/XML team for generating XML format of CT, it is necessary to ensure that all terminology spreadsheets look the same. Therefore, I propose to make the following changes to the ADaM CT spreadhsheet. 1) Remove column F - this is a hold over from previous iterations of the spreadsheet. 2) Change the title of column E from CDISC ADaM Submission Value to CDISC Submission Value - to be inline with SDTM spreadsheet.
In order to further the requirements of the ODM/XML team for getting CT into XML formation, it is necessary to ensure that all terminology spreadsheets look the same. Therefore, I propose to make the following changes to the CDASH spreadsheet. 1) Change the column title of column E from CDISC CDASH Preferred Term to CDISC Submission Value. 2) Change the column title of column F from CDISC CDASH Preferred Term to CDISC Synonym(s) - This is in keeping with the SDTM terminology spreadsheet format.
Please consider adding the above 10 terms to CDISC's SDTM Controlled Terminology Anatomical Locations Codelist in order to be consistent with NCI Terminology. As a precedent, the Anatomical Locations codelist already contains the following terms: Gastrointestinal System and Urinary System. Thank you. APZ/06-Dec-2010
The existing definition for both "Planned number of subjects" and "PLANSUB" is "The number of subjects entered in a clinical trial." This is not correct. The field for "Planned number"/PLANSUB is supposed to hold "The number of subjects planned to be enrolled in a clinical trial." This typically is based on Sample Size calculations. The actual number entered is a different concept.Change the CDISC definition for these 2 entries to "The number of subjects planned to be enrolled in a clinical trial."
To make the codelist more complete and negate the need for self addition of terms to the extensible list
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Please provide LBTEST and LBTESTCD values for the above parameters or update the associated information used in identifying the controlled terminology as either these are missing or are not easily identifiable
PLease provide a Frequency code for the above medication frequecny to be used for oral contraceptives or confirm in notes how this should be mapped
Status
Open ### 30408 LMCO
Open ### 30408 LMCO
Open ### 30409
Open ### 30409
Open ### 30447
Open ### 30447
Open ### 30482
Open ### 30482
Open ### 30483
Open ### 30483
Open ### 30484
Date of Submissio
nRequest
CodeSubmitter
NameSubmitter Affiliation
Submitter E-mail
Request Type
CDISC Codelist
Erin Muhlbradt
Modify Existing Term
SDTM-FREQ
Erin Muhlbradt
[email protected] Existing Term
SDTM-FREQ
john Swithenbank
Create New Term
SDTM-LBTEST
john Swithenbank
[email protected] New Term
SDTM-LBTEST
john Swithenbank
Modify Existing Term
SDTM-LBTEST
john Swithenbank
[email protected] Existing Term
SDTM-LBTEST
Audrey Walker
Charles River
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Laboratories
[email protected] New Term
SDTM-LBTEST
Audrey Walker
Charles River Laboratories
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Laboratories
[email protected] New Term
SDTM-LBTEST
Audrey Walker
Charles River Laboratories
Create New Term
SDTM-LBTEST
Open ### 30484
Open ### 30557 Parexel
Open ### 30557
Open ### 30558 LMCO
Open ### 30558 LMCO
Open ### 30559
Audrey Walker
Charles River Laboratories
[email protected] New Term
SDTM-LBTEST
Richard Shaw
Create New Term
SDTM-LBTEST
Richard Shaw
PAREXEL International
[email protected] New Term
SDTM-LBTEST
Erin Muhlbradt
Modify Existing Term
SDTM-LBTEST
Erin Muhlbradt
[email protected] Existing Term
SDTM-LBTEST
Brian V. Harrington
ERT (eResearch Technology)
Create New Term
SDTM-EGSTRESC
Open ### 30559
Open ### 30740
Open ### 30741 LMCO
Brian V. Harrington
ERT (eResearch Technology)
[email protected] New Term
SDTM-EGSTRESC
John Swithenbank
[email protected] Existing Term
SDTM-VSTESTCD
Erin Muhlbradt
[email protected] Existing Term
SDTM-LBTEST
Open ### 30742
Open ### 30743
Open ### 30744
Open ### 30745 GSK
OtherOpen ### 30746 GSK
Open ### 30747
Open ### 30759 LMCO Other Other
Anna Pron-Zwick
AstraZeneca Pharmaceuticals
[email protected] New Term
SDTM-LBTESTCD
John Swithenbank
[email protected] New Term
SDTM-LBTEST
Anna Pron-Zwick
AstraZeneca Pharmaceuticals
[email protected] Existing Term
SDTM-LBTESTCD
Claire West
Claire West
[email protected] New Term
SDTM-UNIT
Monica Mattson
Celgene Corporation
[email protected] New Term
SDTM-LOC
Erin Muhlbradt
Open ### 30860 J&J
Open ### 30861 Chris Tolk CDISC
Open ### 30862 LMCO
Open ### 30863 MPI
Open ### 30864
Open ### 30866
Open ### 30867
Open ### 30868
Open ### 30869 Chris Tolk CDISC
Nik Pemble
[email protected] Existing Term
SDTM-LBTEST
[email protected] Existing Term
SDTM-TSPARM
Erin Muhlbradt
[email protected] New Term
SDTM-EGEST
Dennis Noe
[email protected] New Terms & Modify Existing Terms
SDTM-PKPARM
Guy Genereux
Sunovion Pharmaceuticals Inc.
[email protected] Existing Term
SDTM-LBTEST
Guy Genereux
Sunovion Pharmaceuticals Inc.
[email protected] Existing Term
SDTM-TSPARMCD
Guy Genereux
Sunovion Pharmaceuticals Inc.
[email protected] Existing Term
SDTM-LBTEST
David Borbas
Jazz Pharmaceuticals
[email protected] New Term
SDTM-VSTEST
[email protected] Existing Term
SDTM-TSPARM
Open ### 30895
Open ### 30896 LMCO
Open ### 30897 LMCO
Open ### 30898 LMCO
Open ### 30899 LMCO
Open ### 30936 LMCO
Open ### 30937 LMCO
Open ### 30938 LMCO
Open ### 30939
Open ### 30940
Open ### 31000
Open ### 31001
David Borbas
Jazz Pharmaceuticals
[email protected] New Term
SDTM-EGMETHOD
Erin Muhlbradt
[email protected] Existing Term
SDTM-FREQ
Erin Muhlbradt
[email protected] Existing Term
SDTM-PKUNIT
Erin Muhlbradt
[email protected] Existing Term
SDTM-AGEU
Erin Muhlbradt
[email protected] Existing Term
SDTM-UNIT
Erin Muhlbradt
[email protected] Existing Term
CDASH-EXDOSFRQ
Erin Muhlbradt
[email protected] Existing Term
CDASH-EXDOSFRQ
Erin Muhlbradt
[email protected] Existing Term
CDASH-EXDOSFRQ
John Swithenbank
Create New Term
SDTM-LBTEST
John Swithenbank
Create New Term
SDTM-FREQ
Fugui Dong
Pharmanet
Create New Term
SDTM-LBTESTCD
Fugui Dong
Pharmanet
Create New Term
SDTM-LBTESTCD
Open ### 31002
Open ### 31003 LMCO Other
Open ### 31050
Open ### 31102 Merck
Open ### 31103 Merck
Open ### 31104 Merck
Open ### 31105 Merck
Open ### 31281 Covance None
Open ### 31282 Merck
Open ### 31283
Open ### 31284
Open ### 31285
Fugui Dong
Pharmanet
Create New Term
SDTM-LBTESTCD
Erin Muhlbradt
SDTM-LOC
Tore Haglund
AstraZeneca
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Allen Glover
Create New Term
Debbie O'Neill
Create New Term
SDTM-LOC
Nicholas Pemble
Johnson and Johnson
Create New Term
SDTM-SPECCOND
Richard Shaw
PAREXEL INTERNATIONAL
Create New Term
SDTM-UNIT
Richard Shaw
PAREXEL INTERNATIONAL
Create New Term
SDTM-VSTESTCD
Open ### 31286
Open ### 31287 CDISC
Open ### 31288 LMCO
Open ### 31289 CDISC
Open ### 31290 LMCO
Open ### 31291 CDISC Other
Open ### 31292
Open ### 31293 Merck
Open ### 31294 Merck
Richard Shaw
PAREXEL INTERNATIONAL
Create New Term
SDTM-LBTEST
Steve Kopko
Create New Term
SDTM-VSTESTCD
Erin Muhlbradt
Modify Existing Term
SDTM-LBTEST
Steve Kopko
Create New Term
SDTM-FREQ
Modify Existing Term
SDTM-TSPARM
Steve Kopko
SDTM-FREQ
Laura Allen
Merck & Co.
Create New Term
SDTM-LBTEST
Debbie O'Neill
Create New Term
SDTM-FRM
Debbie O'Neill
Create New Term
SDTM-UNIT
Open ### 31295
Open ### 31296
Open ### 31297
Open ### 31312
Open ### 31313
Open ### 31314 SDTM-NY
Open ### 31315
Open ### 31316
Open ### 31374
David Borbas
Jazz Pharmaceuticals
Modify Existing Term
SDTM-SOC
john Swithenbank
Create New Term
SDTM-VSRESU
john Swithenbank
Create New Term
SDTM-LBTEST
Michael Ward
Eli Lilly and Company
Modify Existing Term
SDTM-STENRF
Michael Ward
Eli Lilly and Company
Modify Existing Term
SDTM-SEX
Michael Ward
Eli Lilly and Company
Modify Existing Term
Bess LeRoy
Create New Term
SDTM-FREQ
Bess LeRoy
Create New Term
SDTM-UNIT
David Borbas
Jazz Pharmaceuticals
Create New Term
SDTM-TTYPE
Open ### 31375 Amgen
Open ### 31400
Open ### 31412 Other
Open ### 31413 Other
Open ### 31414 Other
Open ### 31415 Other
Open ### 31416
Open ### 31417
Open ### 31418
Open ### 31428
Dan O'Connell
Create New Term
SDTM-FREQ
Rhonda Facile
CDISC-NCI-EVS
Modify Existing Term
SDTM-DATEST
Guy Genereux
Sunovion Pharmaceuticals Inc.
SDTM-LOC
Guy Genereux
Sunovion Pharmaceuticals Inc.
SDTM-LOC
Guy Genereux
Sunovion Pharmaceuticals Inc.
SDTM-DOMAIN
Guy Genereux
Sunovion Pharmaceuticals Inc.
SDTM-UNIT
Laura Allen
Merck & Co.
Create New Term
SDTM-LBTEST
Modify Existing Term
SDTM-DOMAIN
Modify Existing Term
SDTM-UNIT
Guy Genereux
Sunovion Pharmaceuticals Inc.
Modify Existing Term
SDTM-VSTEST
Open ### 31429
Open ### 31430
Open ### 31431
Open ### 31432
Open ### 31433
Open ### 31434
Open ### 31435
Open ### 31436 LMCO None
Open ### 31437 LMCO None
Open ### 31438 LMCO None
Guy Genereux
Sunovion Pharmaceuticals Inc.
Sunovion Pharmaceuticals Inc.
Modify Existing Term
SDTM-VSTESTCD
Guy Genereux
Sunovion Pharmaceuticals Inc.
Modify Existing Term
SDTM-LBTEST
Guy Genereux
Sunovion Pharmaceuticals Inc.
Modify Existing Term
SDTM-LBTESTCD
Guy Genereux
Sunovion Pharmaceuticals Inc.
Modify Existing Term
SDTM-LBTEST
Guy Genereux
Sunovion Pharmaceuticals Inc.
Modify Existing Term
SDTM-LBTESTCD
Guy Genereux
Sunovion Pharmaceuticals Inc.
Modify Existing Term
SDTM-LBTEST
Guy Genereux
Sunovion Pharmaceuticals Inc.
Modify Existing Term
SDTM-LBTESTCD
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Open ### 31439 LMCO None
Open ### 31440 LMCO None
Open ### 31441 LMCO None
Open ### 31442 LMCO None
Open ### 31443 LMCo None
Open ### 31444 LMCO None
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Open ### 31445 LMCO None
Open ### 31446 LMCO None
Open ### 31447 LMCO
Open ### 31448 LMCO
Open ### 31449 LMCO
Open ### 31450 LMCO
Open ### 31451 LMCO
Open ### 31452 LMCO
Open ### 31453 LMCO
Open ### 31454 LMCO
Open ### 31455 LMCO
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
SDTM-LOC
Erin Muhlbradt
Modify Existing Term
SDTM-MICROORG
Erin Muhlbradt
Modify Existing Term
SDTM-DICTNAM
Erin Muhlbradt
Modify Existing Term
SDTM-TCNTRL
Erin Muhlbradt
Modify Existing Term
SDTM-UNIT
Erin Muhlbradt
Modify Existing Term
SDTM-COUNTRY
Erin Muhlbradt
Modify Existing Term
SDTM-COUNTRY
Erin Muhlbradt
Modify Existing Term
SDTM-COUNTRY
Erin Muhlbradt
Modify Existing Term
SDTM-UNIT
Open ### 31458 LMCO
Open ### 31459 LMCO
Open ### 31460 LMCO
Open ### 31461 LMCO
Open ### 31462 LMCO
Open ### 31463 LMCO None
Open ### 31464 LMCO
Open ### 31465 LMCO
Erin Muhlbradt
Modify Existing Term
SDTM-LOC
Erin Muhlbradt
Modify Existing Term
SDTM-COUNTRY
Erin Muhlbradt
Modify Existing Term
SDTM-ROUTE
Modify Existing Term
SDTM-UNIT
Erin Muhlbradt
Modify Existing Term
SDTM-UNIT
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
SDTM-ACN
Erin Muhlbradt
Modify Existing Term
SDTM-AGEU
Open ### 31466 LMCO
Open ### 31467 LMCO
Open ### 31468 LMCO
Open ### 31469 LMCO
Open ### 31470 LMCO
Erin Muhlbradt
Modify Existing Term
SDTM-LOC
Erin Muhlbradt
Modify Existing Term
SDTM-PKUNIT
Erin Muhlbradt
Modify Existing Term
SDTM-SPECTYPE
Erin Muhlbradt
Modify Existing Term
SDTM-TOXGR
Erin Muhlbradt
Modify Existing Term
SDTM-UNIT
Open ### 31471 LMCO
Open ### 31472 LMCO
Open ### 31473 LMCO
Open ### 31474 LMCO
Open ### 31475 LMCO
Open ### 31476 LMCO
Open ### 31477 LMCO
Open ### 31478
Open ### 31479
Open ### 31492 Parexel
Erin Muhlbradt
Modify Existing Term
SDTM-OUT
Erin Muhlbradt
Modify Existing Term
SDTM-COUNTRY
Erin Muhlbradt
Modify Existing Term
SDTM-FREQ
Erin Muhlbradt
Modify Existing Term
SDTM-FREQ
Erin Muhlbradt
Modify Existing Term
SDTM-FREQ
Erin Muhlbradt
Modify Existing Term
SDTM-AGEU
Erin Muhlbradt
Modify Existing Term
SEND-SPEC
Fugui Dong
Pharmanet
Create New Term
SDTM-LBTESTCD
Fugui Dong
Pharmanet
Create New Term
SDTM-LBTESTCD
Henry Farkas
Modify Existing Term
SDTM-COUNTRY
Open ### 31493 Roche
Open ### 31501 LMCO
Open ### 31502
Open ### 31503
Open ### 31504
Open ### 31505 Merck
Open ### 31506 Merck
Open ### 31507 Merck
Open ### 31508 Merck
Open ### 31509 Merck
Jonathan Chainey
Create New Term
SDTM-ROUTE
Erin Muhlbradt
Modify Existing Term
SDTM-LBTEST
Laura Allen
Merck & Co.
Create New Term
SDTM-LBTEST
Laura Allen
Merck & Co.
Create New Term
SDTM-LBTEST
Laura Allen
Merck & Co.
Create New Term
SDTM-LBTEST
Debbie O'Neill
Create New Term
SDTM-VSTEST
Debbie O'Neill
Create New Term
SDTM-VSTEST
Debbie O'Neill
Create New Term
SDTM-VSTEST
Debbie O'Neill
Create New Term
SDTM-VSTEST
Debbie O'Neill
Create New Term
SDTM-VSTEST
Open ### 31510 Merck
Open ### 31511 Merck
Open ### 31512 Merck
Open ### 31513 Merck
Open ### 31514
Open ### 31518 CDISC NEW
Open ### 31519 Merck NEW
Open ### 31520 Merck
Open ### 31521 Bayer Other
Debbie O'Neill
Create New Term
SDTM-VSTEST
Debbie O'Neill
Create New Term
SDTM-VSTEST
Debbie O'Neill
Create New Term
SDTM-VSTEST
Debbie O'Neill
Create New Term
SDTM-VSTEST
Randall Austin
GlaxoSmithKline
Create New Term
SDTM-LOC
Shannon Labout
Create New Codelist
Debbie O'Neill
Create New Codelist
Debbie O'Neill
Create New Term
SDTM-UNIT
Melanie Fuellbeck
SDTM-EGLEAD
Open ### 31538 Merck
Open ### 31539 Merck
Open ### 31540 Merck
Open ### 31541 Merck
Open ### 31542 Merck Other
Open ### 31543 Merck
Open ### 31544 Merck
Open ### 31545 Merck
Open ### 31546 Merck
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Erin Muhlbradt
Create New Term
SDTM-SPECTYPE
Open ### 31554 Other
Open ### 31555 LMCO
Open ### 31556 Merck
Open ### 31557 Merck
Open ### 31558 Merck Other NEW
Open ### 31559 Merck Other NEW
Open ### 31560 Merck Other NEW
Jegan Pillaiyar
TAKE Solutions
SDTM-DOMAIN
Erin Muhlbradt
Modify Existing Term
SEND-STSPRM
Debbie O'Neill
Create New Term
SDTM-LBTEST
Debbie O'Neill
Create New Term
SDTM-LBTESTCD
Debbie O'Neill
Debbie O'Neill
Debbie O'Neill
Open ### 31561 Merck Other NEW
Open ### 31562 Merck Other NEW
Open ### 31563 Merck Other NEW
Open ### 31564 Merck Other NEW
Open ### 31565 Merck Other NEW
Open ### 31566 Merck Other NEW
Open ### 31567 Merck Other NEW
Debbie O'Neill
Debbie O'Neill
Debbie O'Neill
Debbie O'Neill
Debbie O'Neill
Debbie O'Neill
Debbie O'Neill
Open ### 31568 Merck NEW
Open ### 31569 Merck NEW
Open ### 31570 Merck NEW
Open ### 31571 Merck
Open ### 31572 LMCO Other
Open ### 31573
Open ### 31574
Open ### 31575
Debbie O'Neill
Create New Codelist
Debbie O'Neill
Create New Term
Debbie O'Neill
Create New Term
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
SDTM-SPECTYPE
Randall Austin
GlaxoSmithKline
Create New Term
SDTM-VSTESTCD
Randall Austin
GlaxoSmithKline
Create New Term
SDTM-SCCD
Randall Austin
GlaxoSmithKline
Create New Term
SDTM-EGTESTCD
Open ### 31576
Open ### 31577
Open ### 31582 Celgene
Open ### 31583 None
Open ### 31584 Merck
Open ### 31588 Merck
Randall Austin
GlaxoSmithKline
Create New Term
SDTM-EGSTRESC
Brittain, Sarah
MDSL International
Create New Term
SDTM-VSTEST
Eileen Gardenhire
Create New Term
SDTM-UNIT
Ilona Panis
Biomedical Systems
Create New Codelist
Debbie O'Neill
Create New Term
SDTM-UNIT
Debbie O'Neill
Create New Term
SDTM-LOC
Open ### 31589 Merck
Open ### 31591 Merck
Open ### 31592 Merck
Open ### 31593 Merck
Open ### 31594 Merck
Open ### 31596 Chris Tolk CDISC
Open ### 31597 Merck
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-LOC
Create New Term
SDTM-LBTEST
Debbie O'Neill
Create New Term
SDTM-LOC
Open ### 31600 Merck
Open ### 31601 Merck
Open ### 31602 Merck
Open ### 31603
Open ### 31608
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Audrey Walker
Charles River Laboratories
Create New Term
SDTM-UNIT
Phil Pochon
Covance Labs
Create New Term
SDTM-LBTESTCD
Open ### 31609 Merck
Open ### 31615 None
Open ### 31630 Merck
Open ### 31631 Merck
Open ### 31633 Merck
Open ### 31634 Merck
Open ### 31635 Merck None
Open ### 31636 Merck
Open ### 31637 Merck
Open ### 31645 Quintiles NEW
Open ### 31646 Quintiles NEW
Open ### 31669
Debbie O'Neill
Create New Term
SDTM-LOC
Theresa Quinn
Modify Existing Term
Oneill, Debra
Create New Term
SDTM-UNIT
Oneill, Debra
Create New Term
SDTM-NCOMPLT
Oneill, Debra
Modify Existing Term
SDTM-NCOMPLT
Oneill, Debra
Create New Term
SDTM-LOC
Oneill, Debra
Create New Term
ALLEN, LAURA
Create New Term
SDTM-LBTEST
Allen, Laura
Create New Term
SDTM-LBTESTCD
Walker, Gary
Create New Term
Walker, Gary
Create New Term
McLaughlin, Sarah
Biogen Idec
Modify Existing Term
SDTM-COUNTRY
Open ### 31673 GSK None
Open ### 31674 Celgene
Open ### 31675 Celgene
Open ### 31676 Celgene
Open ### 31677 Celgene
Open ### 31678 Celgene
Open ### 31679 Celgene
Open ### 31680 Celgene
Open ### 31681 Celgene None
Open ### 31687 Merck None
Austin, Randall
Create New Term
Gardenhire, Eileen
Create New Term
SDTM-EGSTRESC
Gardenhire, Eileen
Create New Term
SDTM-EGTEST
Gardenhire, Eileen
Modify Existing Term
SDTM-LBTEST
Gardenhire, Eileen
Create New Term
SDTM-FREQ
Gardenhire, Eileed
Create New Term
SDTM-NRIND
Gardenhire, Eileen
Create New Term
SDTM-RACE
Gardenhire, Eileen
Create New Term
SDTM-ROUTE
Gardenhire, Eileen
Create New Term
Hernandez, Joyce
Create New Codelist
Open ### 31688 MERCK
Open ### 31689 Merck
Open ### 31690 Merck
Open ### 31702
Open ### 31703
Open ### 31704
Oneill, Debra
Create New Term
SDTM-SPECTYPE
Oneill, Debra
Create New Term
SDTM-LBTEST
Oneill, Debra
Create New Term
SDTM-LBTEST
Frederik Malfait
Hoffmann-La Roche
Modify Existing Term
SDTM-COUNTRY
Frederik Malfait
Hoffmann-La Roche
Create New Term
SDTM-COUNTRY
Anna Pron-Zwick
AstraZeneca
Modify Existing Term
SDTM-LBTEST
New Term or Codelist/Existing Term or Code Number
Add synonym to C25473 QD to be compliant with CDASH v1.1
Add synonym to C25473 QD to be compliant with CDASH v1.1
typographical error
typographical error
Amorphous phosphate
Amorphous phosphate
Amorphous Urate
Amorphous Urate
BLOOD (in Urine)
Please add a code for Tuberculosis. Suggested option LBTEST = Tuberculosis ; LBTESTCD = TB
Please add a code for Tuberculosis. Suggested option LBTEST = Tuberculosis ; LBTESTCD = TB
BLOOD (in Urine)
C74723 - Turbidity
C74723 - Turbidity
Codelist name = ECG Result; Additions to existing codelist
ADENOPL - Adeno Plasma qPCR; ADENOUR - Adeno Urine qPCR; BKVPL - BKV Plasam qPCR; BKVUR - BKV Urine qPCR; CMVPL - CMV Plasma qPCR; EBVPLÂ - EBC Plama qPCR
ADENOPL - Adeno Plasma qPCR; ADENOUR - Adeno Urine qPCR; BKVPL - BKV Plasam qPCR; BKVUR - BKV Urine qPCR; CMVPL - CMV Plasma qPCR; EBVPL - EBC Plama qPCR
Codelist name = ECG Result; Additions to existing codelist
Change the c-code of Glucose.C41376 will need to be re-coded.
Minor edit if possible to change the associated CDISC SYNONYM text to Systolic Blood Pressure to match the CDISC SYNONYM text for VSTEST and to also bring consistency with the presentation as per Diastolic BP
Tyrosine Crystals / CYTYRO / C74683 / Update to definition required
Use of words to express 10^2, 10^3, 10^5, 10^6 etc.
1) BONE MARROW; and (2) SOFT TISSUE
Please consider adding the following to the SDTM LBTEST and LBTESTCD Codelists: Iohexol Glomerular Filtration Rate; Cystatin C Glomerular Filtration Rate; 51Cr-EDTA Glomerular Filtration Rate
Please provide a LBTEST and LBTESTCD for Anti-Factor Xa activity as this parameter is missing from the pick list yet units for its reporting are present in the UNIT terminology. Please consider LBTEST =Anti-Factor Xa activity LBTESTCD = ANTIFXA
Inconsistency between PKUNIT and UNIT codelist in relation to submission values vs synonyms
CDASH terminology spreadsheet - SUNCF codelist code for C25471 and C25627. Copy-paste error. Change codelist code to C83004 in column B of spreadsheet.
Modify existing terms and add new terms to PKPARM/CD codelist.
Oxygen Saturation Percentage -- VSTESTCD O2SAT
AMYLASE - I am having an issue with Amylase. In my trial, we are collecting both pancreatic amylase and total amylase. Currently, Amylase in the terminology is representing pancreatic amylase (per defn). For consistency, the current code should be updated to AMYLASEP and then AMYLASE should be used to represent total amylase.
C49692 - Modify definition to The planned number of subjects entered in a clinical trial
Add term ECG Abnormality to the EGTEST/CD codelist. Suggest ECG Abnormality for EGTEST and EGABNORM for EGTESTCD.
Mycobacterium tuberculosis IFN Gamma Response; Soluble Vascular Cell Adhesion Molecule 1; These --TEST values are longer than 40 chars, which violates SDTM principles.
AGESPAN submission value (code=C20587) should be AGEGROUP to match related TSPARM value of "Age Group". CDISC Synonym should be "Age Group".
Vitamin B9 submission value (code=C74676) should have the words in the CDISC Synonym value reversed in order. Should read "Vitamin B9; Folic Acid" to be consistent with CDISC Synonym values for other vitamins.
C49697 - Change definition for LENGTH to Planned length of observation for a single subject.
Add HOLTER MONITOR to this codelist
C64496 BID
C71205 ug/day; C71211 ug/min; C67406 umol/day; C48152 ug
C25529 HOURS
C25529 HOURS
C25473 - Codelist Name
C78745 - Codelist Name SY
Please provide a frequency code for 5 times daily
TSAT
CHR
C64496; C64527; C64530; C64525; C64498; C64499; C17998 - Codelist Name
Please review and add where applicable codes for the following Lab parameters values where possible (suggestions made below): LBTEST=Herpes Simplex Virus 1 IgG LBTESTCD=HSV1IgG; LBTEST=Herpes Simplex Virus 1 IgM LBTESTCD=HSV1IgM; LBTEST=Herpes Simplex Vir
CA_PHOS
Change concept code C33737 (TARSUS BONE) to C12796
QN = Nightly (Occurring or done each night).
1XWK
5XWK
6XWK
7XWK
AMBIENT
Additional term for unit codelist: FRACTION; cm H20; mL/cm H20
SEND-SPEC - JOINT, STIFLE is a complex joint in the hind limbs of quadruped mammals such as the sheep, horse or dog. It is the equivalent joint to the human knee. It is often the largest synovial joint in the body.
Please add the following terms to the Anatomical Location codelist. Our preference is for addition as submission value terms but if not, can they be added as synonyms. The terms are: BOTH EYES; LEFT EYE; RIGHT EYE; LEFT ARM; RIGHT ARM; BUTTOCK; LEFT BUTTO
New terms for VSTESTCD VSTEST codelists: FIO2 - Fraction of Inspired Oxygen; PA02/FIO2 - Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen; SA02 - Arterial Oxygen Saturation; SPO2 - Peripheral Oxygen Saturation; SPO2/FIO2 - Peripheral Oxygen
C81982
C50400
Add term 'CAPLET' to FRM Codelist
Add unit 'L/h' to Unit codelist
Additional LBTESTCD LBTEST terms; HASA - Human Anti-Sheep Antibody Bridging (Total); HASAIGG - Human Anti-Sheep Antibody IgG; PROTC - Protein C; TNFA - Tumour Necrosis Factor alfa; TNFAFC - Tumour Necrosis Factor alfa (FC)
VSTESTCD VSTEST Definition - TRSKNF  Triceps skinfold thickness        NINDS Definition: Triceps skinfold thickness - centimeters; SSSKNF  Subscapular skinfold thickness NINDS Definition: Subscapular skinfold thickness - centimeters; HDCIRC  Head C
Additional Dose Frequency value = XX times per month; Defined as the "number of times per month" the medication was taken. The investigator enters the number on the CRF
Request the additional FREQUENCY values based on the NINDS definition = Average or typical frequency during the year of greatest use. List number of uses per day (_/d), week (_/w), month (_/m), or year (_/y), as applicable. XX times per day; XX times per
LBTEST:Â Interleukin 2 Receptor; LBTESTCD: INTLK2R
Please supply a new lab test for lab parameter Platelet Crit
Please change 'U' to 'UNKNOWN' (C17998).
Please change 'U' to 'UNKNOWN' (C17998) in SDTM-SEX
Please change 'U' to 'UNKNOWN' (C17998) in SDTM-NY
PER YEAR
PACK
Add the TTYPE values = FOOD EFFECT and TOLERABILITY
Change the SOC to MedDRA sentence case. Example - "CARDIAC DISORDERS" should be "Cardiac disorders"
Please add meter to the Vital signs controlled terminology as we are recieving some heights captured as meters
Every 6 Weeks, Immediately, 5 Times Per Week, and 6 Times Per Week
Duplicate Submission Values of "ST" in DOMAIN codelist
Duplicate Submission Values of "m3" in UNIT codelist
C78721/C78731 Current definition states "The quantity of a product that has been dispensed". DATEST is actually "The descriptive name of the measurement or finding, (e.g., dispensed, returned)".  The Submission Value should be simply be DISPENSED and RE
Duplicate Submission Values of "BASAL GANGLIA" in LOC codelist
Duplicate Submission Values of "MEDULLA OBLANGATA" in LOC codelist
LBTEST: Atherogenic Index; ALBTESTCD: ATHEROIN / LBTEST: Histoplasma Antibody; ALBTESTCD: HISTOAB / LBTEST: Rheumatoid Factor IgM Antibody; LBTESTCD: RFIGMAB / LBTEST: Tourniquet Test; LBTESTCD: TORNIQT / LBTEST: Ethanol Gelation; LBTESTCD: ETHANGEL / LBT
The domain with the two letter abbreviation ST is used twice. It is used for the Stress (Excercise) Test Data domain (C49614) and for the Subject Stages domain (C95099).
The submission value m3 is used for two different codes (C42570 and C68858).
Change the Synonym to "Knee to Heel Length" for VSTEST='Knee to Heel Length', or at least add "Knee to Heel Length" as the first synonym.
CDASH-CMDOSFRM; C78418
CDASH-CMDOSU; C78417
CDASH-CMDOSU; C48579
Change the Synonym to "Knee to Heel Length" for VSTESTCD='KNEEHEEL', or at least add "Knee to Heel Length" as the first synonym.
Change the order of Synonyms such that "Norepinephrine" is first for LBTEST='Norepinephrine'
Change the order of Synonyms such that "Norepinephrine" is first for LBTESTCD='NOREPIN'.
Change the Synonym to "Extractable Nuclear Antigen Antibody" for LBTEST='Extractable Nuclear Antigen Antibody', or at least add "Extractable Nuclear Antigen Antibody" as the first synonym.
Change the Synonym to "Extractable Nuclear Antigen Antibody" for LBTESTCD='ENAAB', or at least add "Extractable Nuclear Antigen Antibody" as the first synonym.
Change the order of Synonyms such that "Vitamin B9 " is first for LBTEST='Vitamin B9'.
Change the order of Synonyms such that "Vitamin B9" is first for LBTESTCD='VITB9'.
CDASH-CMDOSFRQ; C78419
CDASH-CMROUTE; C78420
CDASH-CMDOSU; C48155
CDASH-EGORRESU; C49673
SEND-SSTYP; Update NCI PTs on published spreadsheet
SEND-SPECIMEN; Add synonyms to following terms (C12499; C12510; C12777; C12809) to be in line with other CDISC standards and published spreadsheets.
SEND-SPECIMEN; SDTM-LOC; Update definition for C12381
SEND-SPECIMEN; Duplicate on codelist - C12429 - LIMB/EXTREMITIES
C12452; C12784
C86465
C66788
C66785
C70526
C64374
C64377
C16695
C29846; C49668
C12231
MULTIPLE codes in this codelist
Multiple codes within this codelist
C25529; C25613; C28251; C29844; C42554; C49670
C49673; C49674; C67069
Update NCI PT on spreadsheet to match what is in the NCIt database
C48660
SDTM-AGEU/SDTM-UNIT - C25529
Addition of synonyms due to use of terms in other codelists.
C12692; C13188; C13325; C77666
C41337; C48275
Addition of synonyms to PKUNIT codelist due to use of terms in other codelists.
Addition of synonyms in UNIT codelist due to use of terms in other codelists.
C48275
C49619
C64496
C67069
C71127
C66781
C33822
URR
KTV
I would like to suggest updating the country code for Serbia from SCG to SRB. (C64377)
INTRAVENOUS PUSH
Change C96615 to C60832
LBTEST: Conductivity; LBTESTCD: CONDUCT
LBTEST: Reticulocytes Corrected; LBTESTCD: RETICCOR
LBTEST: Reticulocytes Corrected/Erythrocytes; LBTESTCD: RECORRBC
Forced Expiratory Volume in 1 Second (test code: FEV1)
Predicted Forced Expiratory Volume 1 Sec (test code: FEV1PR)
Percent Predicted FEV1 (test code: FEV1PPR)
Peak Expiratory Flow (test code: PEF)
Predicted Peak Expiratory Flow (test code: PEFPR)
Percent Predicted Peak Expiratory Flow (PEFPPR)
Forced Vital Capacity (test code: FVC)
Forced Expiratory Flow 25-75% (test code: FEF25_75)
Intraocular Pressure (test code: IOP)
Creation of new Test Category codelist
L/sec
EGLEAD (CUI: C90013)
DIAPHRAGM, DUODENUM, GENITALIA, ILIAC CREST, OROPHARYNX, PELVIC REGION, PLEURA, RETROPERITONEUM, SCALP
Need a codelist to support the proposed new --RELSUB variable in SDTM
SYNOVIAL FLUID
PLEURAL FLUID
PROSTATIC FLUID
BIOPSY
TISSUE BIOPSY
TUMOR BIOPSY
BRAIN TUMOR BIOPSY
FINE-NEEDLE ASPIRATION BIOPSY
BUCCAL SWAB
C66734
C69208; C90462
HLA-B27 Antigen
HLAB27AG
Forced Expiratory Volume in 1 Second (test code: FEV1)
Predicted Forced Expiratory Volume 1 Sec (test code: FEV1PR)
Percent Predicted FEV1 (test code: FEV1PPR)
Peak Expiratory Flow (test code: PEF)
Predicted Peak Expiratory Flow (test code: PEFPR)
Forced Vital Capacity (test code: FVC)
Forced Vital Capacity (test code: FVC)
Percent Predicted Peak Expiratory Flow (PEFPPR)
Forced Expiratory Flow 25-75% (test code: FEF25_75)
Intraocular Pressure (test code: IOP)
FEV1/FVC (test code: FEV1FVC)
FEV1 Reversibility (test code: FEV1REVR)
FORMALIN-FIXED, PARAFFIN-EMBEDDED TISSUE
FFPE Tissue
New VSTEST terms
SDTM-Non Laboratory Test Name and SDTM-Non Laboratory Test Code
Add the following Subject Characteristic Code: CHDPOT (Child bearing potential)
Add the following EGTEST: QT Interval, Corrected and corresponding EGTESTCD: QTC
New terms for EGSTRESC
WAIST CIRCUMFERENCE, with WAISTCIR as VSTESTCD
Create New Term: mL/min/1.73m^2 or mL/min/square surface area
Create New Codelist: Peakflow Data Set
Create New Term: D (submission term) and Diopter (synonym)
Create New Term: COSTOCHONDRAL JOINT 1
Term Suggestion for CDISC Terminology: COSTOCHONDRAL JOINT 7
Term Suggestion for CDISC Terminology: ILIAC CREST
Term Suggestion for CDISC Terminology: SPINOUS PROCESS, L5
Term Suggestion for CDISC Terminology: ILIAC SPINE, POSTERIOR SUPERIOR
Term Suggestion for CDISC Terminology: ACHILLES TENDON, PROXIMAL INSERTION
Add Iohexol Clearance, Add DTPA Clearance, Add EDTA Clearance, Add GRF from Beta-trace Protein Adjusted for BSA, Add GRF from Beta-2 Microglobulin Adjusted for BSA
Term Suggestion for CDISC Terminology: ILIAC SPINE, ANTERIOR SUPERIOR
Term Suggestion for CDISC Terminology: SKIN PUNCH
Term Suggestion for CDISC Terminology: Skin Punch Biopsy
Term Suggestion for CDISC Terminology: HAIR FOLLICLE
Please add the following units to the Unit codelist: mU/L, mU/L
LBTESTCD LBTEST Synonym Notes
Term Suggestion for CDISC Terminology: CENTRAL NERVOUS SYSTEM
Enter Term or Codelist Request Information
Add terms to new Laterality codelist RIGHT SIDE LEFT SIDE
new term to new list - patientdeathreport
a new term to new list - patientdetermineautopsy
Change Serbia to SRB
CDISC Addition of 3 terms to codelist dB / SY: Decibel per month (submission term) Per Month (synonym) NIGHTS PER WEEK
CDISC Addition of 2 terms to codelist WITHDRAWAL BY PARENT/GUARDIAN SUBJECT REFUSED
CDISC Change existing Definition of codelist NCOMPLT Can the definition be updated to include tests as a completion marker in the study.
New Terms for existing lists EAR, RIGHT EAR, LEFT TEMPOROMANDIBULAR JOINT SY:TMJ METACARPOPHALANGEAL JOINT 1 (submission term) / MCP1 (synonym) METACARPOPHALANGEAL JOINT 2 (submission term) /MCP2 (synonynm) "METACARPOPHALANGEAL JOINT 3 (submission term) M
additional terms to exisiting codelist LBTEST: Clusterin LBTEST: Chlamydia Trachomatis IgA Antibody
additional terms to existing list-LBTESTCD: CLUSTERN LBTESTCD: CTIGAAB
OPEN TREATMENT; BLIND TREATMENT
Luekocyte Cell Clumps
Q12M; QAM; QHS;
OTHER;
Genetic Sample
ACUTE RIGHT VENTRICULAR MI; ACUTE SEPTAL MI; ADVANCED/ HIGH GRADE AV BLOCK; ATRIAL BIGEMINY; ATRIAL COUPLETS; ATRIAL TRIGEMINY; BORDERLINE LEFT ATRIAL ENLARGEMENT; DECREASE IN AXIS; DEXTROCARDIA; EARLY R WAVE TRANSITION; EARLY REPOLARIZATION; FUSION COMPL
Axis; Comparison to Baseline; Conduction; Electrocardiogram Test Results; Interpretation; Morphology; Myocardial Infarction; Pacemaker; Repolarization; Rhythm/Arrhythmia; ST Segment; T Wave; U Wave;
ABNORMAL ALERT for Abnormal Alert for Non/Quantitative Results;; ABNORMAL PANIC for Abnormal Panic for Non/Quantitative Results;; HIGH ALERT for High Alert for Quantitative Results;; HIGH PANIC for High Panic for Quantitative Results;; LOW ALERT; LOW PANI
IMPLANT; INJECTION; INTRAJEJUNAL; INTRANASAL; INTRAORAL; INTRATRACHEAL; OSTOMY; PALATAL; RADIATION;
10^12/L for Tera per Liter; 10^9/L for Giga per Liter; CIGARETTES for Cigarettes; CIGARS for Cigars; DRINKS for Drinks; PIPES for Pipes;
LESION
Motility (with the Test Code MOTILITY)
C74763 - CASTS; C74673 - CRYSTALS
Sperm Concentration (with the test code CONCSPM); Sperm Count (with test code COUNTSPM)
For the country Serbia, change the code SCG (transitional reserved) to SRB (current ISO code).
Add terms for BES (Bonaire, Sint Eustasius and Saba), for CUW (Curacao), for SSD(South Sudan), and for SXM (Sint Maarten (Dutch)).
Detailed Description
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Option missing from codelist III
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There does not seem to be a CDISC measurement for Blood (in the urine). III
Change Type
Add synonym of 'Once Daily' to concept QD in SDTM-FREQ codelist. QD/Quaque Die literally means Once a day or Once daily. This change will then ensure that terminology is aligned with CDASH 1.1.
Add synonym of 'Once Daily' to concept QD in SDTM-FREQ codelist. QD/Quaque Die literally means Once a day or Once daily. This change will then ensure that terminology is aligned with CDASH 1.1.
There seems to be a typographical error in the codelist for the following Laboratory test and associated synonym and NCI term. Should Luekocyte Cell Clumps not be Leukocyte Cell Clumps for this test and the associated information in LBTEST and LBTESTCD.
There seems to be a typographical error in the codelist for the following Laboratory test and associated synonym and NCI term. Should Luekocyte Cell Clumps not be Leukocyte Cell Clumps for this test and the associated information in LBTEST and LBTESTCD.
in the Lab Package 6 Amorphous Cyrstal contains both phospate and urate we measure them both separately, therefore they both need terms
in the Lab Package 6 Amorphous Cyrstal contains both phospate and urate we measure them both separately, therefore they both need terms
in the Lab Package 6 Amorphous Cyrstal contains both phospate and urate we measure them both separately, therefore they both need terms
in the Lab Package 6 Amorphous Cyrstal contains both phospate and urate we measure them both separately, therefore they both need terms
There does not seem to be a CDISC measurement for Blood (in the urine). III
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Virology assays encountered in clinical study data mapped to SDTM LB domain
Virology assays encountered in clinical study data mapped to SDTM LB domain
Remove the synonym 'Clarity' from the concept 'Turbidity'. Clarity has been determined to be non-synonymous and will be put in as a separate term with P6 terminology.
Remove the synonym 'Clarity' from the concept 'Turbidity'. Clarity has been determined to be non-synonymous and will be put in as a separate term with P6 terminology.
Thank you for the opportunity to review the controlled terminology Package 6. We reviewed the terminology and noticed there are some potential ECG finding that are missing in the ECG Result SDTM Terminology. I listed all of these potential findings below. We would like to see if it is possible to include these findings within the SDTM to ensure our customers remain CDISC compliant. We welcome any questions you may have on the list of potential findings below: Normal Sinus Rhythm; Other Rhythm; Unable to Assess; Atrial Bigeminy; Frequent Atrial Premature Complexes (>2); Frequent Atrial Premature Complexes (>3); Frequent Ventricular Premature Complexes (>2); Other Conduction; Prolonged QTc; Other ST Segment; Digitalis Effect; Other T Waves; Abnormal U Waves; Absent [U Wave]; Other U Waves; Indeterminate; Other Axis; Antero Lateral MI V3-V6; Antero Septal MI V1-V4; Extensive Anterior MI 1, L, V1-V6; High Lateral MI 1, AVL; Myocardial Ischemia; New Anterior MI V3, V4; New Antero Lateral MI V3-V6; New Antero Septal MI V1-V4; New Extensive Anterior MI 1, L, V1-V6; New High Lateral MI 1, AVL; New Inferior MI (2), 3, F; New Lateral MI 1, L, V5, V6; New Septal MI V1, V2, (V3); New or Acute MI; Old Anterior MI V3, V4; Old Antero Lateral MI V3-V6; Old Antero Septal MI V1-V4; Old Extensive Anterior MI 1, L, V1-V6; Old High Lateral MI 1, AVL; Old Inferior MI (2), 3, F; Old Lateral MI 1, L, V5, V6; Old MI; Old Septal MI V1, V2, (V3); Other Myocardial Infarction; Left Atrial Abnormality; Left Ventricular Hypertrophy Cornell; Left Ventricular Hypertrophy Inferred by LBBB; Left Ventricular Hypertrophy Sokolow-Lyon; Left Ventricular Hypertrophy with Strain; Other Morphology; Abnormal; Unable to Evaluate; Normal; Improved; Deteriorated; Comparison Not Required; Comparison Not Available; Other Finding
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Thank you for the opportunity to review the controlled terminology Package 6. We reviewed the terminology and noticed there are some potential ECG finding that are missing in the ECG Result SDTM Terminology. I listed all of these potential findings below. We would like to see if it is possible to include these findings within the SDTM to ensure our customers remain CDISC compliant. We welcome any questions you may have on the list of potential findings below: Normal Sinus Rhythm; Other Rhythm; Unable to Assess; Atrial Bigeminy; Frequent Atrial Premature Complexes (>2); Frequent Atrial Premature Complexes (>3); Frequent Ventricular Premature Complexes (>2); Other Conduction; Prolonged QTc; Other ST Segment; Digitalis Effect; Other T Waves; Abnormal U Waves; Absent [U Wave]; Other U Waves; Indeterminate; Other Axis; Antero Lateral MI V3-V6; Antero Septal MI V1-V4; Extensive Anterior MI 1, L, V1-V6; High Lateral MI 1, AVL; Myocardial Ischemia; New Anterior MI V3, V4; New Antero Lateral MI V3-V6; New Antero Septal MI V1-V4; New Extensive Anterior MI 1, L, V1-V6; New High Lateral MI 1, AVL; New Inferior MI (2), 3, F; New Lateral MI 1, L, V5, V6; New Septal MI V1, V2, (V3); New or Acute MI; Old Anterior MI V3, V4; Old Antero Lateral MI V3-V6; Old Antero Septal MI V1-V4; Old Extensive Anterior MI 1, L, V1-V6; Old High Lateral MI 1, AVL; Old Inferior MI (2), 3, F; Old Lateral MI 1, L, V5, V6; Old MI; Old Septal MI V1, V2, (V3); Other Myocardial Infarction; Left Atrial Abnormality; Left Ventricular Hypertrophy Cornell; Left Ventricular Hypertrophy Inferred by LBBB; Left Ventricular Hypertrophy Sokolow-Lyon; Left Ventricular Hypertrophy with Strain; Other Morphology; Abnormal; Unable to Evaluate; Normal; Improved; Deteriorated; Comparison Not Required; Comparison Not Available; Other Finding
Minor edit if possible to change the associated CDISC SYNONYM text to Systolic Blood Pressure to match the CDISC SYNONYM text for VSTEST and to also bring consistency with the presentation as per Diastolic BP
Glucose was one of the first labtests that was added to CDISC CT. At that time, it was coded to the concept C41376 Plasma Glucose Measurement in NCIT. I am not convinced that the specimen in which it is being measured should be included within the concept itself and this tends to go against the CDISC data model. I suggest to assign the concept Glucose Measurement to a new c-code as we wouldn't want someone using C41376 if they are measuring glucose in another specimen such as urine, whole blood, etc.
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The three above requests can be measured in both Plasma and Serum. Usual unit of measurement reported for all three types of GFR measurements is mL/min/1.73 m2. These are more specific as to the substance being cleared when measuring GFR. Included are some links for additional information: http://www.diazyme.com/products/reagents/DZ133C-3.php; http://jasn.asnjournals.org/content/7/1/118.abstract; http://ndt.oxfordjournals.org/content/13/5/1176.abstract. Thank you for your consideration.
Please provide a LBTEST and LBTESTCD for Anti-Factor Xa activity as this parameter is missing from the pick list yet units for its reporting are present in the UNIT terminology. Please consider LBTEST =Anti-Factor Xa activity LBTESTCD = ANTIFXA
Please consider amending definition from "A measurement of the triple phosphate crystals present in a biological specimen." to "A measurement of tyrosine crystals present in a biological specimen." Thank you. 09-Feb-2011/APZ
In UNIT, mg/mL and g/L are synonyms of kg/m3 (C71620). In PKUNIT, mg/mL is a valid submission value and kg/m3 is a synonym of it. LAB data fits better within the PKUNIT codelist in relation to the level of unit. For example, you would always express Hemoglobin concentration in g/L, never in kg/m3. Has any consideration been given to creating a LBUNIT codelist for laboratory data in order to make the submission value more in keeping with the data itself?
I know I've asked a similar question back in Nov 2010 but wanted to add to it. Existing unit terms seem to make use of 'thousand', billion' or'million' rather than using a '10 to the power of'(10^) convention which is used extensively in laboratory data. This makes for very long unit codes, especially; 10^4 = ten thousand; 10^5 = hundred thousand; 10^9 = thousand million = US Billion; 10^12 = million million = UK Billion; As you can see, Billion is not the same in UK and US terminology. This makes using the word very risky in relation to lab data as both 10^9 and 10^12 are used routinely. Therefore I would like to request use of 10^ or 10* terminology be added to the terminology list.
Request addition of these two new terms that are not currently available in the Anatomical Location codelist.
CDASH terminology spreadsheet - SUNCF codelist code for C25471 and C25627. Copy-paste error. Change codelist code to C83004 in column B of spreadsheet.
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All modifications and additions are in file from Dennis Noe. II/III
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Consistency of related terms will enable better edit checking for CT items. II
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I am not sure whether the published terminology can be changed, but if it can, then this is definately a candidate for change.Right now, to make the difference in my company dictionary, I am going to have to create AMYLASET to represent total amylase and differential it from the CDISC AMYLASE (pancreatic amylase).....and this is really going against the CDISC terminology principles.
This discussion came from a SHARE meeting at FDA. All of the existing ECG tests on the EGTEST codelist have numeric result values. However, there are no EGTEST that have results that can be reported as character values and/or that correspond to the published EGSTRESC codelist. Suggest to add a test' ECG Abnormality' to the EGTEST codelist which can be used as the test value for all of the corresponding EGSTRESC codelist values. See page 128 of the SDTM IG for further clarification of the issue.
These --TEST values are longer than 40 chars, which violates SDTM principles. Should be shortened to <= 40 chars.
Related to this request: the CDISC Synonym values for LBTESTCDs = VITB9 (C74676), VITB1 (C74896), VITB2 (C74898), VITB3 (C74899) should also have their word order reversed. The Vitamim should be mentioned first, then a semicolon, then to chemical name. This would make these values consistent with the CDISC Synonym values in the corresponding LBTEST rows.
We are using this as part of our Vital Signs Panel for some studies. This is also called SaO2 or Pulse Oxygen Saturation. I checked the 2011 Terminology list and did not find this. Sorry if this is a duplicate request
C49697 - Change definition for LENGTH to Planned length of observation for a single subject.
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Add BD as a synonym to BID to be compliant with CDASH II
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Incorrect Codelist Name for concept C25473 I
Lowercase the word 'per' in the codelist name synonym. I
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No current frequency available in the controlled terminology III
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We are currently using Holter Monitor data is some Phase 1 studies. We would like to identify / differentiate the sources of data where we use standard 12 Lead ECGs along with Holter monitors for the same subjects in the dataset
C71205-add mcg/day as a synonym; C71211-add mcg/min as a synonym; C67406-add mcmol/day as a synonym; C48152-addition of mcg to SY list. - For compliance with CDASH and SDTM-UNIT codelist
Add SYs of Hour; hr - For compliance with CDASH and SDTM-UNIT codelist
SY of hr needs to be added - For compliance with CDASH and SDTM-AGEU codelist
Lowercase the word 'per' in the codelist name column for concepts on rows 72-78.
Transferrin saturation: Transferrin saturation, abbreviated as TSAT and measured as a percentage, is a medical laboratory value. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100.
Reticulocyte hemoglobin content: A Test for Diagnosing Iron Deficiency. Reticulocyte hemoglobin content (CHr) measures the amount of hemoglobin in reticulocytes.
Serum calcium and phosphorus product
IIIIncorrect Mapping
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Requesting addition of 1XWK to capture the concept of once per week. Using this to capture the number of times a subject exercises in a week.
Requesting addition of 5XWK to capture the concept of 5 times per week. Using this to capture the number of times a subject exercises in a week.
Requesting addition of 6XWK to capture the concept of 6 times per week. Using this to capture the number of times a subject exercises in a week.
Requesting addition of 7XWK to capture the concept of 7 times per week. Using this to capture the number of times a subject exercises in a week.
Should be added to the CDISC - SEND only Control Terminology list. Domains that could utilize the term. are OM, MA, and MI. It is a joint that was collected in one of our company's study and wil be submitted to the FDA.
The specificity of location is needed for ophthalmic medication administration and vaccination studies.
Can we please either have ambient added as a synonym of Room Temperature or retire the concept of Room Temperature and just have Ambient or have Ambient as an additional term to Room Temperature....Ambient meaning the specimen is that the temperature of it's surroundings.
New terms required to map units encountered on a clinical study to SDTM units controlled terminology.
Additional terms required to map vital signs encountered on a clinical study to apppropriate SDTM terminology controlled terms.
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Caplet is a dosage form used in our drug studies. III
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Additional terms required to map lab test data collected during a clinical study to apppropriate SDTM terminology controlled terms.
This request is for the addition of VS TESTCD & VSTEST as part of the CDISC/NINDS Parkinson's Disease standards. The NINDS Working Group created these new VS tests as part of their Common Data Elements for Parkinson's Disease. The NINDS CDE's form the basis for the CDISC data standards on this Disease Area project. These 3 fields are additonal body measuements on the Risk Factor Questionnaire on Height & Weight. This was a questionnaire developed by an epidemiology working group sponsored by the Collaborative Centers for Parkinson-s Disease Epidemiology Research. It has been validated and is now available in eleven languages.
Typo in Definition. Change definition to: A measurement of the cancer antigen 19-9 in a biological specimen.
This request is for the addition of a new Dose Frequency value as part of the CDISC/NINDS Parkinson's Disease standards. The NINDS Working Group created this value as part of their Common Data Elements for Parkinson's Disease to capture Non-PD Medications . The NINDS CDE's form the basis for the CDISC data standards on this Disease Area project.
Change existing Def to make it useable across SDTM and SEND. Existing: Those units of time that are routinely used to express the age of a person. (NCI) CHANGE TO: Those units of time that are routinely used to express the age of a subject.
This request is for the addition of a new Dose Frequency value as part of the CDISC/NINDS Parkinson's Disease standards. The NINDS Working Group created this value as part of their Common Data Elements for Parkinson's Disease to capture Substance Usage from their Non-Prescribed Drug History CRF . The NINDS CDE's form the basis for the CDISC data standards on this Disease Area project.
Add a new SDTM LBTEST term of Interleukin 2 Receptor. Add a new SDTM LBTESTCD of INTLK2R.
Please add the unit L/h to the Unit codelist. Currently available in the PK Unit codelist but also need this term in the Unit codelist.
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There is no frequency that would indicate per year. III
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This request matches the recently posted CDER document "CDER Common Data Standards Issues Document" UCM254113. Here the advice for MedDRA Terminology is "When using MedDRA for adverse events and medical history terms, sponsors should exactly follow the spelling and case of the MedDRA terms." see page 5. Currently the terms are published in complete upper case and this conflicts with this advice and communication we have received from a reviewing division at FDA.
Please change 'U' to 'UNKNOWN' (C17998) so that it is consistent with corresponding values in 'Action Taken with Study Treatment' 'Outcome of Event', 'Ethnic Group', 'Route of Administration', 'Frequency', and 'Microbiology Susceptibility Testing Result Category.
Please change 'U' to 'UNKNOWN' (C17998) so that it is consistent with corresponding values in 'Action Taken with Study Treatment' 'Outcome of Event', 'Ethnic Group', 'Route of Administration', 'Frequency', and 'Microbiology Susceptibility Testing Result Category.
Please change 'U' to 'UNKNOWN' (C17998) so that it is consistent with corresponding values in 'Action Taken with Study Treatment' 'Outcome of Event', 'Ethnic Group', 'Route of Administration', 'Frequency', and 'Microbiology Susceptibility Testing Result Category.
For packs of cigarettes smoked. The term "PACK" is used in the SU example on page 93 of the SDTM implementation guide (version 3.1.2) but does not appear in the UNIT code list.
We are using these values in a current study and are getting validation errors. This codelist is currently extensible and so we suggest that these values be added.
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Add a new SDTM LBTEST and LBTESTCD term III
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I would like to request that the following terms are added to the Frequency domain. I am unsure as to what the abbreviations should be, but I would like to suggest the codes of: Every 6 Weeks, Immediately, 5 Times Per Week, and 6 Times Per Week. Thanks.
Incorrect definition for DATEST. The quantity of the product dispensed and returned is covered in (C78721/78732 DATESTCD) the DISPAMT and RETAMT.
if the two rows are different and necessary, change Submission Value on one
if the two rows are different and necessary, change Submission Value on one
if the two rows are different and necessary, change Submission Value on one
if the two rows are different and necessary, change Submission Value on one
For consistency with all other "TEST" terminologies where the Submission Value is at least the first Synonym value. (see related request for change to synonym for VSTESTCD='KNEEHEEL'
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Synonym Change from Dose Form to Concomitant Medication Dose Form II
Synonym Change from Dose Units to Concomitant Medication Dose Units II
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For consistency with all other "TESTCD" terminologies where the (first) Synonym is the same as the Submission Value for the related "TEST" term. (see related request for change to synonym for VSTEST='Knee to Heel Length'
For consistency with all other "TEST" terminologies where the Submission Value is at least the first Synonym value. (see related request for change to synonym for LBTESTCD='NOREPI'
For consistency with all other "TESTCD" terminologies where the (first) Synonym is the same as the Submission Value for the related "TEST" term. (see related request for change to synonym for LBTEST='Norepinephrine'
For consistency with all other "TEST" terminologies where the Submission Value is at least the first Synonym value. (see related request for change to synonym for LBTESTCD='ENAAB'
For consistency with all other "TESTCD" terminologies where the (first) Synonym is the same as the Submission Value for the related "TEST" term. (see related request for change to synonym for LBTEST='Extractable Nuclear Antigen Antibody'
For consistency with all other "TEST" terminologies where the Submission Value is at least the first Synonym value. (see related request for change to synonym for LBTESTCD='VITB9'
For consistency with all other "TESTCD" terminologies where the (first) Synonym is the same as the Submission Value for the related "TEST" term. (see related request for change to synonym for LBTEST='Vitamin B9'
NCI PT Change from International Unit of Biological Activity to International Unit
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Synonym Change from Dosing Frequency per Interval to Concomitant Medication Dosing Frequency per Interval
Synonym Change from Route of Administration to Concomitant Medication Route of Administration
Definition Change from A metric unit of mass equal to one one thousandth of a kilogram.(NCI) to A metric unit of mass equal to one one thousandth of a kilogram. (NCI)
Definition Change from The number of heartbeats measured per minute time.(NCI) to The number of heartbeats measured per minute time. (NCI)
C79364 Change From FDA RPS Pharmacology: Primary Pharmacodynamics to Pharmacology: Primary Pharmacodynamics; C79365 Change From FDA RPS Pharmacology: Secondary Pharmacodynamics to Pharmacology: Secondary Pharmacodynamics; C79367 Change From FDA RPS Pharmacology: Pharmacodynamic Drug Interactions to Pharmacology: Pharmacodynamic Drug Interactions; C79368 Change From FDA RPS Analytical Methods And Validation Reports to Analytical Methods and Validation Reports; C79369 Change From FDA RPS Pharmacokinetics: Absorption to Pharmacokinetics: Absorption; C79370 Change From FDA RPS Pharmacokinetics: Distribution to Pharmacokinetics: Distribution; C79371 Change From FDA RPS Pharmacokinetics: Metabolism to Pharmacokinetics: Metabolism; C79372 Change From FDA RPS Pharmacokinetics: Excretion to Pharmacokinetics: Excretion; C79373 Change From FDA RPS Pharmacokinetics: Drug Interactions to Pharmacokinetics: Drug Interactions; C79375 Change From FDA RPS Toxicology: Single Dose Toxicity [Species And Route] to Toxicology: Single Dose Toxicity [Species and Route]; C79376 Change From FDA RPS Toxicology: Repeat Dose Toxicity [Species, Route, Duration] to Toxicology: Repeat Dose Toxicity [Species, Route, Duration]; C79378 Change From FDA RPS Genotoxicity: In Vitro to Genotoxicity: in vitro; C79379 Change From FDA RPS Genotoxicity: In Vivo to Genotoxicity: in vivo; C79380 Change From FDA RPS Toxicology: Carcinogenicity to Toxicology: Carcinogenicity; C79385 Change From FDA RPS Reproductive And Developmental Toxicity: Fertility And Early Embryonic Development to Reproductive and Developmental Toxicity: Fertility and Early Embryonic Development; C79386 Change From FDA RPS Reproductive And Developmental Toxicity: Embryofetal Development to Reproductive and Developmental Toxicity: Embryofetal Development; C79387 Change From FDA RPS Reproductive And Developmental Toxicity: Prenatal And Postnatal Development Including Maternal Function to Reproductive and Developmental Toxicity: Prenatal and Postnatal Development Including Maternal Function; C79388 Change From FDA RPS Studies In Which The Offspring (Juvenile Animals) Are Dosed And/Or Further Evaluated to Studies in which the Offspring (Juvenile Animals) are Dosed and/or Further Evaluated; C79389 Change From FDA RPS Toxicology: Local Tolerance to Toxicology: Local Tolerance; C79391 Change From FDA RPS Other Toxicity Studies: Antigenicity to C12499 Add Internal Ear; C12510 Add Mesencephalon; C12777 Add Radius Bone; C12809 Add Ulna Bone
Remove ' from end of word 'Sternum' within the published definition. I
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Remove (NCI) from end of published definition. I
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Remove 'Name of Dictionary' from synonym of codelist concept. II
Remove 'Type of Control' from synonym of codelist concept. II
Comma in SY list; change to semi-colon I
Change CDISC submission value from JRE to JEY. ISO update. III
Change CDISC submission value from SCG to SRB. ISO update. III
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Duplicate codes within one codelist. One contains LIMB as a submission value and one contains EXTREMITIES as a submission value. SEND must determine which submission value it would like to have. The other row will be removed and that submission value will be listed as a synonym.
Duplicate in SY column; Remove ENTEROBACTER INTERMEDIUM as an SY on the published spreadsheet.
Remove HKG as a synonym. HKG is the submission value and we don't put the three letter ISO codes in as synonyms.
Definition changes: C29846 - Add space between period and (NCI); C49668 - Add period at end of sentence.
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Add (NCI) to end of definition I
Add space between period and (FDA) at end of definition. I
Add space between period and (NCI) at end of definition. I
Add (NCI) to end of definition I
Update NCI PT on spreadsheet to match what is in the NCIt database I
Add 'Not Applicable' as a SY II
IIAdd 'hr' as a SY in SDTM-AGEU codelist. Add Hour and hr as SYs in the SDTM-UNIT codelist. This will bring in-line SDTM and CDASH.
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C12290 - Add Bone, Mandibular, Inferior Maxillary Bone, Jaw; C12292 - Add Auricle; C12311 - Add Uterine Cervix; C12347 - Add Eye Socket, Ocular Orbit, Orbital Cavity; C12381 - Add Cecal, Cecum; C12399 - Add Hypophysis Cerebri, Hypophysis; C12401 - Add Eyeball; C12405 - Add Womb; C12408 - Add External Genitalia; C12412 - Add Testicle; C12428 - Add Windpipe; C12439 - Add Nervous System, Brain; C12470 - Add Integument; C12499 - Add Cochlea, Labyrinth; C12510 - Add Midbrain; C12664 - Add Abdomen; C12683 - Add Bronchi; C12713 - Add Palpebra; C12717 - Add Bone, Femoral; C12719 - Add Ganglia, Neural Ganglion; C12727 - Add Cardiac; C12731 - Add Bone, Humeral; C12743 - Add Crystalline Lens, Lens Of Eye, Ocular Lens; C12763 - Add Accessory Sinuses, Nasal Cavity, Nasal Sinuses; C12767 - Add Pelvic Cavity; C12777 - Add Radius; C12783 - Add Shoulder Blade; C12787 - Add Seminal Sacs; C12789 - Add Bone, Cranial, Cranium; C12793 - Add Sterna; C12796 - Add Bone, Tarsal, Tarsus; C13044 - Add Articulation; C13071 - Add Facial; C32286 - Add Vena Cephalica; C32622 - Add Feet; C32677 - Add Gum; C32742 - Add Coxofemoral Joint; C32898 - Add Tibiofemoral Joint; C33287 - Add Pelvis; C33343 - Add Hepatic Portal Vein; C33718 - Add Synovia; C12441 - Add Brain Stem; C12444 - Add Hippocampus; C12453 - Add Substantia Nigra; C12458 - Add Hypothalamus; C12694 - Add Choroid Plexus; C12905 - Add Thoracic Cavity; C28401 - Add Olfactory Bulb
C64566 - Add g/mL|gram/mL|kg/L|mg/uL; C71205 - Add mcg/day; C67394 - Add mcg/h; C67396 - Add mcg/kg|ng/g; C71211 - Add mcg/min; C67406 - Add mcmol/day; C64387 - Add mcmol/mL|nmol/uL|umol/mL; C42576 - Add mg/mL; C48153 - Add Microliter|mm3; C73755 - Add Milliliter per Gram per Day; C69073 - Add mL/sec; C85723 - Add mmol/s; C67306 - Add ng/mL|mcg/L; C64572 - Add mcg/mL|mg/L|ng/uL|ug/mL; C67405 - Add Micro-International Unit per milliliter; C73760 - Add Milliliter per Kilogram per Minute
Addition of synonyms due to use of terms in other codelists. C12692 - Add CSF; C13188 - Add Aqua Amnii; C13325 - Add Sera; C77666 - Add Emesis
Addition of synonyms due to use of terms in other codelists. C41337 - Add LIFE THREATENING; C48275 - Add FATAL
Addition of synonyms due to use of terms in other codelists. C42554 - Add ohm; C42576 - Add kg/m3 and mg/mL; C48520 - Add Pack Dosing Unit; C64387 - Add mcmol/mL, mmol/L, nmol/uL; C64566 - Add gram/mL, kg/L, mg/uL; C64572 - Add mcg/mL and ng/uL; C64783 - Add g%; C67015 - Add mg%; C67069 - Add Every week; C67306 - Add ng/mL and ug/L; C67396 - Add ng/g and ug/kg; C67405 - Add mIU/L and mcIU/mL
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Remove TE as a synonym. TE is the Submission value. II
Add BD as a synonym. This is in keeping with CDASH spreadsheet. II
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Remove period from end of SY I
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Remove SY of Vena Cephalica. Incorrectly added to term. I
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Addition of synonyms due to use of terms in other codelists. Add FATAL as a synonym.
Add Per Week and Every week as synonyms. This concept is in multiple codelists and every codelist will have the same synonyms.
Change definition of Codelist Term to: Those units of time that are routinely used to express the age of a subject.
Urea Reduction Ratio, a dimensionless number used to quantify dialysis treatment adequacy.
Kt/V, a number used to quantify hemodialysis and peritoneal dialysis treatment adequacy.
The country code for Serbia as specified in the current version of the controlled terminology (SCG) does not correspond with the code specified in ISO 3166-1 alpha 3 (SRB).
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Change NCI c-code of C96615. Term has been merged into C60832. I
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Need for terminology in clinical trials III
Need for terminology in clinical trials III
Need for terminology in clinical trials III
Need for terminology in clinical trials III
Need for terminology in clinical trials III
A study team at Roche asked my team (Roche Data Standards Office) to add the term 'INTRAVENOUS PUSH' as a sponsor-defined extension of the ROUTE codelist. Upon some research the current NCI definitions of the terms INTRAVENOUS PUSH and INTRAVENOUS BOLUS appear to contradict the FDA definition provided in the latest CDISC CT:NCI Thesaurus: IV Bolus: A volume of drug intended to be administered into a vein in 30 minutes or less. IV Push: A method of drug delivery in which a drug is administered quickly into a vein. IV Bolus: Administration within or into a vein or veins all at once.(FDA) Assuming the terms are distinct, please can or someone on the CDISC CT team clarify the correct definition of each term? In particular which way round the terms should be used, or in other words which once describes the quickest administration of a drug intravenously?
Add a new SDTM LBTEST term of Conductivity; Add a new SDTM LBTESTCD of CONDUCT
Add a new SDTM LBTEST term of Reticulocytes Corrected; Add a new SDTM LBTESTCD of RETICCOR
Add a new SDTM LBTEST term of Reticulocytes Corrected/Erythrocytes; Add a new SDTM LBTESTCD of RECORRBC
Need for terminology in clinical trials III
Need for terminology in clinical trials III
Need for terminology in clinical trials III
Need for terminology in clinical trials III
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The existing list contains "male genitalia" and "female genitalia". A more general "genitalia" would be a helpful addition. Pleura: The existing list contains "pleural cavity" but we don't have a term for the actual membrane. Pleura: the serous membrane investing the lungs (visceral p.) and lining the walls of the thoracic cavity (parietal p.); the two layers enclose a potential space, the pleural cavity. Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved. So Pleura refers to the membrane itself.
The RELSUB variable describes the relationship (biological or other) of a person is not a study subject to another person who is a study subject.
For analysis of clinical trials we are requesting the creation of a Test Category codelist containing the following terms: CHEMISTRY, COAGULATION, CYTOGENETICS, ENDOCRINOLOGY, HEMATOLOGY, HISTOLOGY, IMMUNOHEMATOLOGY, IMMUNOLOGY, MICROBIOLOGY, PATHOLOGY, SEROLOGY, TOXICOLOGY, URINALYSIS
Please add the term L/sec with the synonym Liter per Second to the Unit codelist.
Within the ECG domain the EGLOC variable should be used in order to store the information about the lead location used for measurement. As example the following leads are listed: V1, V6, aVR, I, II, III. As controlled terminology codelist, the LOC codelist is assigned to EGLOC, but this "Anatomical location" codelist, does not contain the above mentioned exampled for the lead location. However, the EGLEAD codelist has all these entries and to my understanding, this codelist needs to be assigned to the EGLOC variable. At the moment, the EGLEAD codelist is not mentioned in the SDTM IG and also not referenced in your dropdown list above. Could you please clarify how the lead assignment within ECG should be handled? Best Regards, Melanie
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Please add the term 'SYNOVIAL FLUID' to the Specimen Type codelist. The definition is: The slippery fluid that lubricates joints and provides nutrients to the cartilage. Also known as the synovia. (Source: http://www.medterms.com/script/main/art.asp?articlekey=5686)
Please add the term 'PLEURAL FLUID' to the Specimen Type codelist. The definition is: The thin film of serous fluid between the visceral and parietal pleurae. (Source: http://medical-dictionary.thefreedictionary.com/pleural+fluid)
Please add the term 'PROSTATIC FLUID' to the Specimen Type codelist. The definition is: the secretion of the prostate gland, which contributes to formation of the semen. (Source: http://medical-dictionary.thefreedictionary.com/prostatic+fluid)
Please add the term 'BIOPSY' to the Specimen Type codelist. The definition of biopsy specimen is: Tissue removed from the body and examined under a microscope to determine whether disease is present. (Source: http://www.cancer.gov/dictionary?CdrID=45619)
Please add the term 'TISSUE BIOPSY' as a synonym to the newly requested term 'BIOPSY'.
Please add the term 'TUMOR BIOPSY' to the Specimen type codelist. This is to distinguish between a biopsy specimen that is tissue or when it is the tumor. "In a biopsy, the doctor removes a sample of tissue from the abnormal area or may remove the whole tumor." (Source: http://www.medterms.com/script/main/art.asp?articlekey=2466)
Please add the term 'BRAIN TUMOR BIOPSY' to the Specimen Type codelist. The term Brain is needed to clarify the location of the tumor biopsy. This is in alignment with other Specimen Type terms (i.e. Lung Surfactant) that include the location of the specimen type in the term.
Please add the term 'FINE-NEEDLE ASPIRATION BIOPSY' to the Specimen Type codelist. Reference: http://www.ncbi.nlm.nih.gov/pubmed/16269293
Please add the term 'BUCCAL SWAB' to the Specimen Type codelist. Buccal swab is used to collect cheek cells from the inside of the mouth for DNA testing. Source: http://www.lssu.edu/campuslife/documents/buccal_swab_qa_032306.pdf
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Is there any standards to have dataset label? If so, from where we have to get the label. Since we are confused after referring to some of the pages(No. 13, 17, 18, 19, 274 and the TITLE above the metadata of individual domain,the text right next to [domain].xpt at the beginning of each domain table in the IG. E.g., dm.xpt, Demographics, cm.xpt, Concomitant Medications, eg.xpt, ECG) of SDTM IG 3.1.2 and too referring CDISC Controlled Terminology(codelist name-"Domain Abbreviation") where we found some minor differences with the above referred pages to have domain's label. So it will be consistent to use the CDISC Synonym(s) of the codelist name-"Domain Abbreviation" for datasets label, if CT makes it mandatory or can have a new Term for dataset label.
Change c-codes for Study Start Date and Study End Date. Need to create Nonclinical specific concepts for SEND as these had been incorrectly coded to Clinical-specific concepts.
Please add the Lab test HLA-B27 to the Laboratory Test Name codelist. References: Quest Diagnostics http://www.questdiagnostics.com/hcp/testmenu/jsp/showTestMenu.jsp?fn=48215P.html&labCode=SJC. ARUP Laboratories: http://www.aruplab.com/guides/ug/tests/0095840.jsp
Please add the term HLAB27 to the Laboratory Test Code codelist and associate it with the newly requested term 'HLA-B27 Antigen' in the Laboratory Test Name codelist.
Please move the previously requested term 'Forced Expiratory Volume in 1 Second (test code: FEV1)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please move the previously requested term 'Predicted Forced Expiratory Volume 1 Sec (test code: FEV1PR)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please move the previously requested term 'Percent Predicted FEV1 (test code: FEV1PPR)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
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Please move the previously requested term 'Peak Expiratory Flow (test code: PEF)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please move the previously requested term 'Percent Predicted FEV1 (test code: FEV1PPR)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please move the previously requested term 'Predicted Peak Expiratory Flow (test code: PEFPR)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please move the previously requested term 'Forced Vital Capacity (test code: FVC)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please move the previously requested term 'Percent Predicted Peak Expiratory Flow (PEFPPR)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please move the previously requested term 'Forced Expiratory Flow 25-75% (test code: FEF25_75)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please move the previously requested term 'Intraocular Pressure (test code: IOP)' from the Vital Signs codelist to the newly requested 'Non Laboratory Test Name' and 'Non Laboratory Test Code' codelists. This type of data (Ophthalmology) would be mapped to the OP domain with the variables OPORRES, OPSTRESC and OPSTRSSN.
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The Non Laboratory Test Name codelist would be used to capture diagnostic tests and procedures that do not use a laboratory specimen (ie. Audiometric tests, Spirometry Tests, Ophthalmology tests, etc.). These types of tests don't fit in the Laboratory Test Name or Vital Signs codelist. Proposed definition: A test or procedure not using a laboratory specimen that is performed to diagnose disease, disordered function, or disability.
Please add the term 'FEV1/FVC' to the newly requested codelist 'Non Laboratory Test Name' and the term 'FEV1FVC' to the newly requested codelist 'Non Laboratory Test Code'. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please add the term 'FEV1 Reversibility' to the newly requested codelist 'Non Laboratory Test Name' and the term 'FEV1REVR' to the newly requested codelist 'Non Laboratory Test Code'. This type of data (Spirometry) would be mapped to the VS domain with the variables VSORRES, VSSTRESC and VSSTRSSN.
Please add the term 'FORMALIN-FIXED, PARAFFIN-EMBEDDED TISSUE' to the Specimen Types codelist. References: http://www.asuragen.com/Services/services/sample_prep/FFPE.aspx -AND- http://www.bioserve.com/human-biorepository/sample-types.cfm -AND- http://www.abstracts2view.com/sabcs07/viewp.php?nu=p1112
Please add the term 'FFPE Tissue' as a synonym to the newly requested term 'FORMALIN-FIXED, PARAFFIN-EMBEDDED TISSUE'
Aortic Pulse Wave Velocity(APWV); Augmentation Pressure(AUGPLHT); Central Aug Pressure at HR75(AUGPR); Central Aug/Pulse Height(AUGPR75); Central Diastolic Blood Pressure(CAPHHR75); Central Systolic Blood Pressure(CDIABP); Forearm Circumference(CSYSBP); Heart Rate Adjusted AIx(FARMCIR); Hip Circumference(HIPCIR); Lean Body Mass(LBM); Pulse Pressure(PULP); Waist Circumference(WSTCIR)
Add the following Subject Characteristic Code: CHDPOT (Child bearing potential)
Add the following EGTEST: QT Interval, Corrected and corresponding EGTESTCD: QTC
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WAIST CIRCUMFERENCE, with WAISTCIR as VSTESTCD III
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ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RATE > 100 BPM); ATRIAL PREMATURE DEPOLARIZATION; DYNAMIC HORIZONTAL/DOWN-SLOPING; DYNAMIC HORIZONTAL/DOWN-SLOPING DEPRESSION; FREQUENT VENTRICULAR PREMATURE DEPOLARIZATION (VPD) >= 3; IDIOVENTRICULAR RHYTHM - HEART RATE < 100 BEATS/MIN; JUNCTIONAL ESCAPE COMPLEXES; JUVENILE TWAVE PATTERN, EARLY REPOLARIZATION; LATE R WAVE TRANSITION; LEFT ATRIAL ABNORMALITY; LEFT AXIS DEVIATION (QRS AXIS MORE NEGATIVE THAN -30 DEGREES); MULTIFOCAL ATRIAL TACHYCARDIA (WANDERING ATRIAL PACEMAKER W/RATE >100 BEATS/MIN); NON-SPECIFIC INTRAVENTRICULAR CONDUCTION DELAY (QRS >= 120 MSEC); OCCASIONAL VENTRICULAR PREMATURE DEPOLARIZATION (VPD) <3; PATHOLOGICAL Q WAVES; PERSISTENT ST ELEVATION; PROLONGED QTC INTERVAL 450-500 MSEC; QTCF >= 450 MSEC; RIGHT AXIS DEVIATION (QRS AXIS MORE POSITIVE THAN +110 DEGREES); SINUS BRADYCARDIA (HEART RATE <30 BEATS/MIN); SINUS BRADYCARDIA (HEART RATE 30-39 BEATS/MIN); SINUS BRADYCARDIA (HEART RATE 40-50 BEATS/MIN); ST-T WAVE ABNORMALITIES WITH THE EXCEPTION OF NON-SPECIFIC CHANGES; SUPRAVENTRICULAR TACHYCARDIA (>100/MIN); T WAVE ALTERNANS; TRANSIENT ST ELEVATION; TRIFASCICULAR BLOCK; UNUSUAL P AXIS
This is needed as unit for creatinine clearance and GFR (glomerular filtration rate).
We would like to implement Peak Flow Data into a CDISC compliant format. I already discussed this with Chris Tolk and shall sent him our output fields we currently use.
Please add the the term 'D' to the Unit codelist with the synonym Diopter. Diopter is a unit of measurement of the refractive power of lenses equal to the reciprocal of the focal length measured in meters. Source: http://medical-dictionary.thefreedictionary.com/diopter
Please add the term COSTOCHONDRAL JOINT 1 to the Anatomical Location codelist. Definition: the cartilaginous joints between the sternal end of ribs and the lateral ends of costal cartilages.Reference:http://www.medilexicon.com/medicaldictionary.php
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Please add the term COSTOCHONDRAL JOINT 7 to the Anatomical Location codelist.Definition: the cartilaginous joints between the sternal end of ribs and the lateral ends of costal cartilages. Definition Reference: http://www.medilexicon.com/medicaldictionary.php Term Reference: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1754445/pdf/v062p00127.pdf
Please add the term ILIAC CREST to the Anatomical Location codelist.Definition: the long, curved upper border of the wing of the ilium. (http://www.medilexicon.com/medicaldictionary.php?t=21242)Reference: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1754445/pdf/v062p00127.pdf
Definition: the posterior extremity of the iliac crest, the uppermost point of attachment of the sacrotuberous and posterior sacroiliac ligaments; a readily apparent dimple occurs in the skin overlying the posterior superior iliac spine that is clinically useful as an indication of the level of the S2 vertebra, the level of the inferior limit of the subarachnoid space. (http://www.medilexicon.com/medicaldictionary.php)Reference: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1754445/pdf/v062p00127.pdf
Please add the term ACHILLES TENDON, PROXIMAL INSERTION to the Anatomical Location codelist. Reference: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1754445/pdf/v062p00127.pdf
Please add the term SPINOUS PROCESS, L5 to the Anatomical Location dictionary. References: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1754445/pdf/v062p00127.pdf -and- http://www.medilexicon.com/medicaldictionary.php?t=72343
Note this is entered for Ron Perrone: Add Iohexol Clearance, Add DTPA Clearance, Add EDTA Clearance, Add GRF from Beta-trace Protein Adjusted for BSA, Add GRF from Beta-2 Microglobulin Adjusted for BSA
Please add the term ILIAC SPINE, ANTERIOR SUPERIOR to the Anatomical Location codelist.Definition: the anterior extremity of the iliac crest, which provides attachment for the inguinal ligament and the sartorius muscle. http://www.medilexicon.com/medicaldictionary.php). Reference: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1754445/pdf/v062p00127.pdf
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Please add the term 'SKIN PUNCH' to the Specimen Type codelist. Reference: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2153859/pdf/canfamphys00231-0125.pdf
Please add the term 'Skin Punch Biopsy' as a synonym for the recently requested term 'SKIN PUNCH' to the Specimen Type codelist.
Please add the term 'HAIR FOLLICLE' to the Specimen Type codelist. Definition: a tubelike invagination of the epidermis from which the hair shaft develops and into which the sebaceous glands open; the follicle is lined by a cellular inner and outer root sheath of epidermal origin and is invested with a fibrous sheath derived from the dermis. http://www.medilexicon.com/medicaldictionary.php?t=34408 Reference: For Drug Testing http://www.craigmedical.com/Hair_Drug_Test.htm
Follicle Stimulating Hormone is measured using the unit mU/mL; Thyroid Stimulating Hormone is measured using the unit mU/L
APOC2 Apolipoprotein C2 Apolipoprotein CII;APOJ Apolipoprotein J Clusterin Overexpressed in Cancer and Alzheimer's Biomarker;HOMA-IR Homostat Model Assess. of Insulin Rest. homeostatic model assessment of insulin resistance;A1AGLP Alpha-1-Acid Glycoprotein;A1MGLB Alpha-1-Microglobulin Protein HC;A1MCREAT Alpha1-Microglobulin Creatinine Ratio;AAP Alanine Aminopeptidase;APCREST Activated Protein C Resistance Factor V Leiden Screen ;ANTDNASB AntiDnase B Screening Test for Streptococcus Group A (Throat Infection);ANTHROM3 Antithrombin III AT3 ;ANTM3ACT Antithrombin III Activity;APPTLAS Lupus Anticoagulant Sensitive APTT APPT-LA;BETACRTN Beta Carotene b-Carotene, Beta Carotin;APOC2 Apolipoprotein C2 Apolipoprotein CII;APOJ Apolipoprotein J Clusterin Overexpressed in Cancer and Alzheimer's Biomarker;HOMA-IR Homostat Model Assess. of Insulin Rest. homeostatic model assessment of insulin resistance;A1AGLP Alpha-1-Acid Glycoprotein;A1MGLB Alpha-1-Microglobulin Protein HC;A1MCREAT Alpha1-Microglobulin Creatinine Ratio;AAP Alanine Aminopeptidase;APCREST Activated Protein C Resistance Factor V Leiden Screen ;ANTDNASB AntiDnase B Screening Test for Streptococcus Group A (Throat Infection);ANTHROM3 Antithrombin III AT3 ;ANTM3ACT Antithrombin III Activity;APPTLAS Lupus Anticoagulant Sensitive APTT APPT-LA;BETACRTN Beta Carotene b-Carotene, Beta Carotin;
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Add terms to new Laterality codelist RIGHT SIDE LEFT SIDE III
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additional terms to existing list-LBTESTCD: CLUSTERN LBTESTCD: CTIGAAB III
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Change term to be consistent with ISO-3166
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Please add the term 'CENTRAL NERVOUS SYSTEM' to the Anatomical Location codelist.Definition: the brain and the spinal cord. (http://www.medilexicon.com/medicaldictionary.php?t=89268)
The definitions require modification so that the (FDA) attribution is removed at the end.
CDISC Addition of 3 terms to codelist dB / SY: Decibel per month (submission term) Per Month (synonym) NIGHTS PER WEEK
CDISC Addition of 2 terms to codelist WITHDRAWAL BY PARENT/GUARDIAN SUBJECT REFUSED
Can the definition be updated to include tests as a completion marker in the study. The current definition 'The status of the subject's completion of the study or a segment of the study, or the reason the subject discontinued the study or segment of the study.' includes segment of the study which would pertain to a phase rather than an individual aspect (ie. test) in the study.
New Terms for existing lists EAR, RIGHT EAR, LEFT TEMPOROMANDIBULAR JOINT SY:TMJ METACARPOPHALANGEAL JOINT 1 (submission term) / MCP1 (synonym) METACARPOPHALANGEAL JOINT 2 (submission term) /MCP2 (synonynm) "METACARPOPHALANGEAL JOINT 3 (submission term) M
additional terms to exisiting codelist LBTEST: Clusterin LBTEST: Chlamydia Trachomatis IgA Antibody
patientdeathreport Reason for suggestion plus any other additional information: Need a test code for reported reason of death. This should be aligned to the e2b reporting element B.1.9.2.b "In case of death: Reported cause(s) of death"
patientdetermineautopsy Reason for suggestion plus any other additional information: Need a test code for reported reason of death from an autopsy. This should be aligned to the e2b reporting element B.1.9.4b "In case of death: Autopsy-determined cause(s) of death"
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Every year; In the morning; Before bedtime; III
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Units needed for Hematology results; units for substance use (SU)
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OPEN TREATMENT A period in a clinical study during which subjects receive open label therapeutic treatment. {needed for study design where open label treatment needs to distinguished from blinded treatment}; BLIND TREATMENT A period in a clinical study during which subjects receive blinded therapeutic treatment. {needed for study design where open label treatment needs to distinguished from blinded treatment}
ACUTE RIGHT VENTRICULAR MI; ACUTE SEPTAL MI; ADVANCED/ HIGH GRADE AV BLOCK; ATRIAL BIGEMINY; ATRIAL COUPLETS; ATRIAL TRIGEMINY; BORDERLINE LEFT ATRIAL ENLARGEMENT; DECREASE IN AXIS; DEXTROCARDIA; EARLY R WAVE TRANSITION; EARLY REPOLARIZATION; FUSION COMPL
Axis; Comparison to Baseline; Conduction; Electrocardiogram Test Results; Interpretation; Morphology; Myocardial Infarction; Pacemaker; Repolarization; Rhythm/Arrhythmia; ST Segment; T Wave; U Wave;
this test is misspelled in CDISC controlled terminology as 'Luekocyte Cell Clumps', correct spelling to "Leukocyte Cell Clumps
ABNORMAL ALERT for Abnormal Alert for Non/Quantitative Results;; ABNORMAL PANIC for Abnormal Panic for Non/Quantitative Results;; HIGH ALERT for High Alert for Quantitative Results;; HIGH PANIC for High Panic for Quantitative Results;; LOW ALERT; LOW PANIC
Reason for suggestion plus any other additional information: per SDTM IG one is allowed to store OTHER as RACE in DM and further specify race in SUPPDB
Other routes that medications can be received. No current term covers these.
List of material extracted from biological specimens such as Deoxyribonucleic acid or Ribonucleic acid which are made up of long nucelotides to be used for molecular analysis.
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Reason for suggestion plus any other additional information: Please add the term "LESION" to the Specimen Type codelist. Lesion is being used in our clinical trials. The definitions for this term are: A pathologic change in the tissues; OR One of the individual points or patches of a multifocal disease. (http://www.medilexicon.com/medicaldictionary.php?t=48927)
Please add the term Motility to the Laboratory Test Name codelist and the term MOTILITY to the Laboratory Test Code codelist. This test is used in Semen Analysis and is used to measure the sperm capable of forward, progressive movement in a biological specimen.
Please add the term Sperm Concentration to the Laboratory Test Name codelist and the term CONCSPM to the Laboratory Test Code codelist. This test is used in Semen Analysis and is used to measure the amount of sperm in a specified volume of a semen sample. This is different than the existing term Spermatozoa which would be used in the count of sperm in a urine sample, which would have a numeric result of sperm per field while Sperm Concentration has the unit of million per milliliter. Please add the term Sperm Count to the Laboratory Test Name codelist and the term COUNTSPM to the Laboratory Test Code codelist. This test is used in Semen Analysis and is a calculation of the sperm concentration multiplied by the semen sample size. This is different than the existing term Spermatozoa which would be used in the count of sperm in a urine sample, which would have a numeric result of sperm per field while Sperm Count has the unit of million per ejaculate or million per specimen.
Please review definitions for Casts and Crystals and consider modifying to e.g. "A statement that indicates casts were looked for in a biological specimen." and "A statement that indicates crystals were looked for in a biological specimen."
Status
Open ### 31765 NEW
Open ### 31766 NEW
Open ### 31767 NEW
Open ### 31768 NEW
Open ### 31771 Merck
Open ### 31772 Merck
Open ### 31773 Merck
Open ### 31774 Merck
Open ### 31775 Merck
Date of Submissio
nRequest
CodeSubmitter
NameSubmitter Affiliation
Submitter E-mail
Request Type
CDISC Codelist
Troy Smyrnios
MPI Research
Create New Term
Troy Smyrnios
MPI Research
Modify Existing Term
Troy Smyrnios
MPI Research
Modify Existing Term
Troy Smyrnios
MPI Research
Modify Existing Term
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-FREQ
Open ### 31776 Merck
Open ### 31777 Merck
Open ### 31778 Merck
Open ### 31779 Merck
Open ### 31780 Merck
Open ### 31781 Merck
Open ### 31782 Merck
Open ### 31783 Merck
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Open ### 31784 Merck
Open ### 31785 Merck
Open ### 31786 Sanofi
Open ### 31787 Sanofi
Open ### 31788 Sanofi
Open ### 31789
Open ### 31790
Open ### 31791
Open ### 31792 Merck
Open ### 31793 Merck
Debbie O'Neill
Create New Term
SDTM-FREQ
Debbie O'Neill
Create New Term
SDTM-FREQ
Carol Vaughn
Modify Existing Term
SDTM-LBTEST
Carol Vaughn
Modify Existing Term
SDTM-LBTEST
Carol Vaughn
Modify Existing Term
SDTM-COUNTRY
frank senk
astrazeneca
Create New Term
SDTM-VSTESTCD
Sandra Abensohn
Create New Term
SDTM-LBTEST
frank senk
astrazeneca
Create New Term
SDTM-UNIT
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-LOC
Open ### 31794
Open ### 31795 Shire
Open ### 31796 Shire Other
Open ### 31797 Shire
Open ### 31798 Shire
Open ### 31799 Shire
Open ### 31800 Shire
Open ### 31803 Shire
Open ### 31804 Shire
Monica Mattson
Celgene Corporation
Create New Term
SDTM-LBTESTCD
Janet Siani
Modify Existing Term
SDTM-LBTESTCD
Janet Siani
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-VSTESTCD
Janet Siani
Create New Term
SDTM-VSTESTCD
Janet Siani
Create New Term
SDTM-EGTESTCD
Janet Siani
Create New Term
SDTM-EGTESTCD
Janet Siani
Create New Term
SDTM-EGTESTCD
Janet Siani
Create New Term
SDTM-EGTESTCD
Open ### 31805 Shire
Open ### 31806 Shire
Open ### 31807 Shire
Open ### 31808 Shire NEW
Open ### 31809 Shire
Open ### 31810 Shire
Open ### 31811 Shire
Open ### 31812 Shire
Open ### 31813 Shire
Open ### 31814 Shire
Janet Siani
Create New Term
SDTM-EGTESTCD
Janet Siani
Create New Term
SDTM-EGTESTCD
Janet Siani
Create New Term
SDTM-EGTESTCD
Janet Siani
Create New Codelist
Janet Siani
Create New Term
SDTM-LOC
Janet Siani
Create New Term
SDTM-FREQ
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTEST
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Open ### 31815 Shire
Open ### 31816 Shire
Open ### 31817 Shire
Open ### 31818 Instem
Open ### 31819 Shire
Open ### 31820 Shire
Open ### 31821 Shire
Open ### 31822 Shire
Open ### 31823 Shire
Open ### 31824 Shire
Open ### 31825 Shire
Open ### 31826 Shire
Open ### 31827 Shire
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Jennifer Feldmann
Create New Codelist
SDTM-RELTYPE
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-FRM
Open ### 31828 Shire NEW
Open ### 31829 Shire NEW
Open ### 31830 Shire NEW
Open ### 31831 Shire NEW
Open ### 31832 Shire NEW
Open ### 31833 Shire
Open ### 31834 Shire
Open ### 31835 Shire
Open ### 31836 Shire
Open ### 31837 Shire
Open ### 31838 Shire
Open ### 31839 Shire
Janet Siani
Create New Codelist
Janet Siani
Create New Term
Janet Siani
Create New Term
Janet Siani
Create New Term
Janet Siani
Create New Term
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-NCOMPLT
Janet Siani
Create New Term
SDTM-NCOMPLT
Open ### 31840 Shire
Open ### 31841 Shire NEW
Open ### 31842 Shire NEW
Open ### 31843 Shire NEW
Open ### 31844 Shire
Open ### 31845 Shire
Open ### 31846
Open ### 31847
Open ### 31848
Open ### 31849 Merck
Open ### 31850 Merck
Janet Siani
Create New Term
SDTM-NCOMPLT
Janet Siani
Create New Codelist
Janet Siani
Create New Codelist
Janet Siani
Create New Codelist
Janet Siani
Create New Term
SDTM-LBTESTCD
Janet Siani
Create New Term
SDTM-LBTESTCD
john.swithenbank
Create New Term
SDTM-LBTESTCD
john.swithenbank
Create New Term
SDTM-LBTESTCD
Barrie Nelson
CDISC SDS Oncology Team
Create New Term
SDTM-RSSTRESC
Debbie O'Neill
Create New Term
SDTM-LBTESTCD
Debbie O'Neill
Modify Existing Term
SDTM-LBTEST
Open ### 31851 C-PATH
Open ### 31852 C-PATH
Open ### 31853 C-PATH
Open ### 31854 C-PATH
Open ### 31855 Chris Tolk CDISC
Open ### 31856 NCI-EVS
Open ### 31857 NCI-EVS
Bess LeRoy
Create New Term
SDTM-FREQ
Bess LeRoy
Create New Term
SDTM-FREQ
Bess LeRoy
Create New Term
SDTM-FREQ
Bess LeRoy
Create New Term
SDTM-FREQ
Create New Term
SDTM-UNIT
Erin Muhlbradt
Modify Existing Term
SDTM-TTYPE
Erin Muhlbradt
Modify Existing Term
SEND-DESIGN
New Term or Codelist/Existing Term or Code Number
SEND-NEOPLASM - C3146 (Keratoacanthoma)
SEND-NEOPLASM - C3764 (Adenomatous Polyp)
SEND-NEOPLASM - C6803 (Benign Ovarian Sex Cord-Stromal Tumor)
PARA-AORTIC LYMPH NODE
PERIHILAR LYMPH NODE
PERIPANCREATIC LYMPH NODE
LIVER BIOPSY
Days one, three, five, seven every cycle
SEND-Neoplasm - Undifferentiated (Embryonal) Sarcoma; Benign Cardiac Schwannoma
CYCLE4X; Synonym: Four times a cycle
Q8S; Synonym: once every eight weeks
Q6S; Synonym: once every six weeks
Q5S; Synonym: once every five weeks
WK1 ON WK1 OFF; Synonym: One week on One week off
WK1 ON WK2 OFF; Synonym: One week on Two weeks off
WK1 ON WK3 OFF; Synonym: One week on Three weeks off
WK2 ON WK1 OFF; Synonym: Two weeks on One week off
WK2 ON WK2 OFF; Synonym: Two weeks on Two weeks off
WK3 ON WK1 OFF; Synonym: Three weeks on One week off
HIPCIRC Hip Circumference; WSTCIRC Waist Circumference
New Additions to LAB terminology
cm/s
CNS - Submission Value; Central Nervous System - Synonym
OTHER
Please shorten the value of "Mycobacterium tuberculosis IFN Gamma Response" to 40 characters or less.
Please shorten the value of "Soluble Vascular Cell Adhesion Molecule 1" to 40 characters or less.
The country code for "Serbia" should be "SRB" not "SCG".
TRGTCE: add synonyms 1) Codocytes and 2) Mexican hat cells
VSTESTCD: WAISTCIR / VSTEST Waist Circumference
VSTESTCD: TBW / VSTEST: Total Body Water
EGTESTCD: QTCFMEDN / EGTEST: Summary (Median) QTcF
EGTESTCD: EGINTPR / EGTEST: Detailed overread Interpretation
EGTESTCD: HRMEDN / EGTEST: Summary (Median) Heart Rate
EGTESTCD: PRMEDN / EGTEST: Summary (Median) PR Duration
Request new term EBVVLD, corresponding to new suggested LBTEST "Epstein-Barr Virus Viral Load".
LBTESTCD = TRAP: Please change the value to TRTAP. We will request a new term added with TRAP as the suggested code. (Synthetic peptides corresponding to the N-terminal tethered ligand sequence, commonly known as thrombin receptor-activating peptide (TR
EGTESTCD: QRSMEDN / EGTEST: Summary (Median) QRS Duration
EGTESTCD: QTMEDN / EGTEST: Summary (Median) QT Duration
EGTESTCD: RRMEDN / EGTEST: Summary (Median) RR Duration
DACAT / Values: RESCUE MEDICATION / STUDY MEDICATION
Loc: SUBLINGUAL
Freq: HS / Synonyms: At betime., QHS
LBTESTCD: H2 / LBTEST: Hydrogen
p50 / LBTEST: p50
CD34POS / LBTEST: CD34
Add Synonym for newly requested LBTESTCD p50: Oxygen Dissociation
LEUKALP / LBTEST: Leukocytes Alkaline Phosphatase
LBTESTCD: DRGABUSE / LBTEST: Drugs of Abuse
LBTESTCD: ADP / LBTEST: Adenosine diphosphate
LBTESTCD: ADPAUC / LBTEST: Adenosine diphosphate AUC
LBTESTCD: ADPMA / LBTEST: Adenosine diphosphate Max Agg
LBTESTCD: ADPV / LBTEST: Adenosine diphosphate Velocity
LBTESTCD: COLLAGEN / LBTEST: Collagen
CAPSULE, OPEN
FACTXIV / LBTEST: Factor XIV / Synonyms: Autoprothrombin IIA, Blood Coagulation, Prot C
LBTESTCD: DAMPHET / LBTEST: d-amphetamine / Synonym: Dextroamphetamine
We'd like this RELTYPE codelist to be available for the SEND RELREC variable RELTYPE, instead of the RELTYPE variable having two possible entries listed in the SENDIG domain table.
LBTESTCD: TRAPMA / LBTEST: Thrombin receptor-activated peptide MA
LBRESTCD: TRAPV / LBTEST: Thrombin receptor-activated peptide Vel
LBCAT
For Codelist LBCAT, ALCOHOL SCREEN
For new codelist LBCAT, CHEMISTRY
Codelist AEREL; Values NOT RELATED, RELATED
LBTESTCD: FVL / LBTEST: Factor V Leiden
LBTESTCD: PG20210A / LBTEST: Prothrombin G20210A
LBTESTCD: CLUECE / LBTEST: Clue Cells
RANDOMIZED
DRUG INTERRUPTION
For new codelist, LBCAT 6 new terms: COAGULATION, DRUGS OF ABUSE SCREEN, HEMATOLOGY, PLATELET AGGREGATION, PREGNANCY, URINALYSIS
LBTESTCD: APLAB / LBTEST: Anti-phospholipid antibodiesÂ
LBTESTCD: METHAMPHÂ / LBTEST: Methampetamine
DRUG RESUMPTION
LBTESTCD: ARA / LBTEST: Arachidonic Acid
New Codelist PCSPCCND. / Associated values: CLOTTED; HEMOLYZED; INSUFFICIENT VOLUME; LIPEMIC
New Codelist SUCAT; Associated values: ALCOHOL; CAFFEINE; TOBACCO
New Codelists SCTEST / SCTESTCD / Associated values: SCTESTCD: EYECOLOR / SCTEST: Eye Color / SCTESTCD: INITIALS / SCTEST: Initials / SCTESTCD: CBPOT / SCTEST: Subject is of Childbearing Potential
SCTESTCD: PREGSTAT / SCTEST: Pregnancy Status - associated with newly requested codelist SCTESTCD / SCTEST
Please create a new LBTEST and LBTESTCD for the parameeters listed below: PTT-LA (Partial Thromboplastin Time - Lupus Anticoagulant) Lupus Anicoagulant; Immature Reticulocyte Fraction IRF; Generic Drug Screen
Please provide a new LBTEST and LBTESTCD for the parameter listed below: Von Willebrand factor Antigen
Multiple updaes requested based on feedback recieved during the public review of the onclogy domain package
Please add the synonym of 'Urine Density' to the Submission Term 'Specific Gravity'
Please add the synonym of 'Ammonium Urate Crystals' to the Submission Term 'Ammonium Biurate Crystals'.
less than once/yr
1-5 times/yr
daily/constant
None
Add term UNITS. This is the unit of measure for whole blood.
C49667; No spaces in between some words in definition.
C82637; C82638; C82639
Detailed Description
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Change Type
Please add the following terms to the NEOPLASM list: Undifferentiated (Embryonal) Sarcoma (C27096); Benign Cardiac Schwannoma (C5358)In addition, please add respective synonyms of: SARCOMA, UNDIFFERENTIATED, MALIGNANT, SCHWANNOMA, ENDOCARDIAL, BENIGN
Please add a synonym for C3416 of "KERATOACANTHOMA, BENIGN".
Please add a synonym for C3764 of POLYP, GLANDULAR, BENIGN.
Please add a synonym for C6803 of SEX-CORD/STROMAL TUMOR, BENIGN.
Please add the term PARA-AORTIC LYMPH NODE to the Anatomical Location codelist. Para-aortic lymph node are Lymph nodes located next to the major blood vessel that carries oxygenated blood throughout the body.
Please add the term PERIHILAR LYMPH NODE to the Anatomical Location codelist. Perihilar lymph nodes are lymph nodes that are in the vicinity of an organ where nerves and vessels enter and leave.
Please add the term PERIPANCREATIC LYMPH NODE to the Anatomical Location codelist. Reference: http://www.ncbi.nlm.nih.gov/pubmed/6362986
Please add the term LIVER BIOPSY to the Specimen Type codelist. This is a term used in our clinical trials to designate the type of specimen being tested.
Please add the term DAYS 1, 3, 5, 7/CYCLE with the synonym Days one, three, five, seven every cycle to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment within one cycle of a treatment period.
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Please add the term CYCLE4X with the synonym Four times a cycle to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment within one cycle of a treatment period.
Please add the term Q8S with the synonym once every eight weeks to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment.
Please add the term Q6S with the synonym once every six weeks to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment.
Please add the term Q5S with the synonym once every five weeks to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment.
Please add the term WK1 ON WK1 OFF with the synonym One week on One week off to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment with the treatment cycle lasting one week and then a week off before starting treatment again.
Please add the term WK1 ON WK2 OFF with the synonym One week on Two weeks off to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment with the treatment cycle lasting one week and then two weeks off before starting treatment again.
Please add the term WK1 ON WK3 OFF with the synonym One week on Three weeks off to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment with the treatment cycle lasting one week and then three weeks off before starting treatment again.
Please add the term WK2 ON WK1 OFF with the synonym Two weeks on One week off to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment with the treatment cycle lasting two weeks and then one week off before starting treatment again.
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LBTEST values may not exceed 40 characters II
LBTEST values may not exceed 40 characters II
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These values collected in AstraZeneca study. III
See Attached spreadsheet III
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Please add the term WK2 ON WK2 OFF with the synonym Two weeks on Two weeks off to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment with the treatment cycle lasting two weeks and then two weeks off before starting treatment again.
Please add the term WK3 ON WK1 OFF with the synonym Three weeks on One week off to the Frequency codelist. This term is used in our clinical trials to capture the frequency of treatment with the treatment cycle lasting three weeks and then one week off before starting treatment again.
Due to recent ISO changes. Please see the following link: http://www.iso.org/iso/pressrelease.htm?refid=Ref1031
The unit codelist has m/sec. Perhaps you could add cm/sec?
Please add the term CNS to the Anatomical Location codelist with the synonym Central Nervous System. This term is used in our oncology trials.CNS encompasses the brain and the spinal cord. (Reference: http://www.medilexicon.com/medicaldictionary.php?t=89268)
Please add the term OTHER to the Anatomical Location codelist. This term is used to capture the location that is different from the others previously specified in the codelist.
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Measurement of Total Body Water III
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ECG interpretation provided by Overreader. III
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Request new term EBVVLD, corresponding to new suggested LBTEST "Epstein-Barr Virus Viral Load".
From Wikipedia: Codocytes, also known as target cells or Mexican hat cells are red blood cells that have the appearance of a shooting target with a bullseye. The cells have a dark center (a central, hemoglobinized area) surrounded by a white ring (an area of relative palor), followed by dark outer (peripheral) second ring containing a band of hemoglobin.
Synthetic peptides corresponding to the N-terminal tethered ligand sequence, commonly known as thrombin receptor-activating peptide (TRAP) mimics almost all the activities of the thrombin. See http://www.kerafast.com/p-193-trap-thrombin-receptor-activating-peptide.aspx
Measurement of the abdomen between the rib cage and the hips commonly used to assess abdominal obesity
The median duration (time) of the correct QTC interval, obtained from a set of measurements of the QT interval and corrected using the Fridiricia's correction Formula.
The median number of cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate.
The medianduration (time) of the PR interval, obtained from a set of measurements of the PR interval. The PR interval is defined as the time from the beginning of the P wave (representing the onset of atrial depolarization) to the beginning of the R wave (representing the onset of ventricular depolarization). In some cases, a Q wave will precede the R wave, in which case the PR interval is measured from the beginning of the P wave to the beginning of the Q wave.
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Under the Tongue III
Every night III
Measurement of Hydrogen in a biological specimen. III
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III
The median duration (time) of the QRS interval, obtained from a set of measurements of the QRS interval. The QRS interval is defined as the time from the beginning of the QRS complex to the end of the QRS complex, representing the time it takes for the ventricles to depolarize.
The median duration (time) of the QT interval, obtained from a set of measurements of the QT interval. The QT interval is defined as the time from the beginning of the QRS complex to the end of the T wave, representing the time it takes for the ventricles to depolarize and subsequently repolarize. In some cases, the Q wave will be absent, in which case the QT interval is measured from the beginning of the R wave to the end of the T wave.
The median duration (time) of the RR interval, obtained from a set of measurements of the RR interval. The RR interval is defined as the time between successive peaks of the R wave and can be used to measure the ventricular rate.
Category for Drug Accountability / Rescue Medication: Non-surgical medical treatment in life-threatening situations // Study Medication: An active drug that is being studied in a clinical trial.
This test calculates the partial pressure of oxygen when haemoglobin is half saturated (SO2=50%) in a blood sample. The result is corrected to standard conditions of pH=7.400, CO} = 40 mmHg, and a temperature of 37.
This is the number of cells in a blood sample which contain the CD34 protein
This test calculates the partial pressure of oxygen when haemoglobin is half saturated (SO2=50%) in a blood sample. The result is corrected to standard conditions of pH=7.400, CO} = 40 mmHg, and a temperature of 37.
III
III
III
III
III
III
Area under the curve for Adenosine diphosphate III
Maximum aggregation for Adenosine diphosphate III
Velocity for Adenosine diphosphate III
III
III
III
Open capsule III
Measures amount of Alkaline Phosphataste found within white blood cells
Also known as autoprothrombin IIA and blood coagulation factor XIV, is a protein, the activated form of which plays an important role in regulating blood clotting, inflammation, cell death and maintaining the permeability of blood vessel walls in humans and other animals.
Measurement of d-amphetamine in a biological sample.
To collect routine drug screens where specific drug results are not listed
A coenzyme composed of adenosine and two molecules of phosphoric acid that is important in intermediate cellular metabolism.
A group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of mammals. It is the main component of connective tissue
Note: Request assumes that the LBTESTCD value, TRAP, will be assigned to Thrombin receptor-activated peptide. Currently, this is assigned to another term. Maximum aggregation for Thrombin receptor-activated peptide.
Note: Request assumes that the LBTESTCD, TRAP, is assigned to Thrombin receptor-activated peptide. Currently, this is assigned to another term. Velocity for Thrombin receptor-activated peptide.
Category for Laboratory Tests III
Screen for presence of alcohol in a biological sample. III
III
III
III
III
III
III
LBTESTCD: CLUECE / LBTEST: Clue Cells III
III
III
III
Set of laboratory tests that measure chemicals in the blood
COAGULATION: Set of laboratory tests used to assess the function of the coagulation system; DRUGS OF ABUSE SCREEN: Set of laboratory tests used to measure the amount of illicit drugs in a biological sample; HEMATOLOGY: Set of laboratory tests used to measure the components of the blood; PLATELET AGGREGATION: Set of laboratory tests used to assess the functon of platelets.; PREGNANCY: Laboratory tests used to measure the presence of pregnancy hormones.; URINALYSIS: Set of laboratory tests used to measure the components in a urine sample
AEREL (Relationship to Adverse Event); NOT RELATED: Investigator indicates the Adverse Event was not related to the drug under study.; RELATED: Investigator indicates the Adverse Event was related to the drug under study.
Detect several specific phospholipid-binding proteins that the body produces against itself in an autoimmune response to phospholipids.
This test is used to diagnose suspected factor V Leiden disorder (an inherited blood-clotting condition.
Gene Mutation. A common genetic risk factor for thrombosis (clots) including deep venous thrombosis (DVT).
A measurement of any methamphetamine drug present in a biological specimen
Subject is randomized.
Interruption of study medication dosing not related to an Adverse Event.
III
III
III
III
III
III
III
III
III
II
II
Resumption of study drug medication dosing following an interruption that was not related to an Adverse Event.
New codelist: PCSPCCND: Condition of the Pharmacology Specimen.; CLOTTED: A specimen that has become coagulated.; HEMOLYZED: A specimen that has undergone the destruction of red blood cells followed by the release of the hemoglobin.; INSUFFICIENT VOLUME: Inadequate volume of specimen in order to conduct the test.; LIPEMIC: A specimen that consists of or contains excessive amounts of fat and fatty substances.
CODELIST SUCAT: Category for Substance Use. ALCOHOL: Alcohol Use; CAFFEINE: Caffeine Use; TOBACCO: Tobacco Use
SCTESTCD / SCTEST: Set of subject characteristics // SCTESTCD EYECOLOR: Color of a subject's eyes / SCTESTCD INITIALS: Subject's Initials / SCTESTCD CBPOT: Subject is of Childbearing Potential
polyunsaturated omega-6 fatty acid that is present in the phospholipids
Subject's Pregnancy Status - associated with newly requested codelists for SCTESTCD/SCTEST
I have sent a list of terms in spreadsheet format to Chris Tolk via email
The test Specific Gravity is also known as a urine density test. Please add 'urine density' as a synonym to the test Specific Gravity.
The test Ammonium Biurate Crystals is also known as Ammonium Urate Crystals. Please add 'Ammonium Urate Crystals' as a synonym to the test Ammonium Biurate Crystals.
Add as part of PKD development III
Add as part of PKD development III
Add as part of PKD development III
Add as part of PKD development III
II
I
II
Add term UNITS. This is the unit of measure for whole blood.
Existing: A studythat assessesthemedical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, includingadverse events, vital signs, physical exam, laboratory tests. Change: A study that assesses the medical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, including adverse events, vital signs, physical exam, laboratory tests.
SDTM and SEND have slightly different definitions for these three terms and currently we have two different CDISC definitions in the database. I can't make separate concepts however because the definitions are too similar in meaning for us to logically split them up. CDISC must make a decision on which definition stays and which needs to be deleted.
Status
Open ### 32479 Janssen
Open ### 32480 Janssen
Open ### 32487 MULTIPLE
Open ### 32488
Open ### 32491 Covance
Open ### 32492 Covance
Open ### 32493 Covance
Date of Submissio
nRequest
CodeSubmitter
NameSubmitter Affiliation
Submitter E-mail
Request Type
CDISC Codelist
Nicholas Pemble
Modify Existing Term
SDTM-LBTEST
Nicholas Pemble
Create New Term
SDTM-LBTEST
David Turner
Shire Pharmaceuticals
Create New Term
Anna Pron-Zwick
AstraZeneca Pharmaceuticals
Create New Term
SDTM-LBTEST
Carrie Neeley
Modify Existing Term
SEND-STRAIN
Carrie Neeley
Create New Term
SDTM-LBTEST
Phil Pochon
Create New Term
SDTM-MICROORG
Open ### 32494 Covance
Open ### 32495 MULTIPLE
Open ### 32496 BMS
Open ### 32499 Covance
Open ### 32500 Merck
Open ### 32501 Merck
Open ### 32502 Janet Shire
Open ### 32503 Janet Shire
Open ### 32504 Celgene
Open ### 32505 MSC Inc.
Carrie Neeley
Modify Existing Term
SDTM-LBTEST/CD
Annette E Inker
Quality Data Services, Inc.
Modify Existing Term
Cheryl Sloan
Create New Term
SDTM-LBTEST
John Swithenbank
Modify Existing Term
SDTM-TPHASE
Debbie O'Neill
Create New Term
SDTM-UNIT
Debbie O'Neill
Modify Existing Term
SDTM-LOC
Modify Existing Term
QS-C-SSRS Baseline TESTCD
Modify Existing Term
QS-CSSRS Since Last Visit
Aimee Basile
Create New Term
SDTM-LBTEST
Erin Muhlbradt
Create New Term
SDTM-ROUTE
Open ### 32506 MSC Inc.
Open ### 32508 MSC Inc.
Open ### 32509 MSC Inc.
Open ### 32520 CDISC
Open ### 32521 Merck
Open ### 32522 Merck Other
Open ### 32523 CDISC None Other
Open ### 32524 CDISC
Erin Muhlbradt
Create New Term
SDTM-UNIT
Erin Muhlbradt
Modify Existing Term
QS-QSCAT
Erin Muhlbradt
Modify Existing Term
SDTM-CCINVCTYP
Bernice Yost
Modify Existing Term
SDTM-PKPARM/CD
Joyce Hernandez
Create New Term
SDTM-DOMAIN
Joyce Hernandez
SDTM-DOMAIN
Steve Kopko
Bernice Yost
Create New Term
SDTM-UNIT
Open ### 32525 Spencer
Open ### 32526 CDISC
Open ### 32527 CDISC None
Open ### 32528 CDISC
Open ### 32529 CDISC
Open ### 32536 Merck
Open ### 32537
Takeda Pharmaceuticals
Modify Existing Term
SDTM-METHOD
Bernice Yost
Create New Term
SDTM-ROUTE
Bernice Yost
SDTM-METHOD
Bernice Yost
Create New Term
SDTM-LOC
Bernice Yost
Modify Existing Term
SDTM-DOMAIN
Debbie O'Neill
Create New Term
SDTM-METHOD
frank senk
astrazeneca
Modify Existing Term
SDTM-GRSTNLOC
Open ### 32538
Open ### 32539
Open ### 32540
Open ### 32541
Open ### 32542
Open ### 32543
Open ### 32544
Audrey Walker
Charles River Labs
Modify Existing Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Scott Bahlavooni
Roche/Genentech
Create New Term
SDTM-PKPARMCD
Open ### 32545
Open ### 32546
Open ### 32547
Open ### 32548 Lilly
Open ### 32549
Open ### 32550
Open ### 32551
Open ### 32552
Open ### 32553
Open ### 32554
Open ### 32555
Open ### 32556
Open ### 32557
Open ### 32558
Scott Bahlavooni
Roche/Genentech
Create New Term
SDTM-PKPARM
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Tom Morrow
Create New Term
SDTM-METHOD
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Open ### 32559
Open ### 32561
Open ### 32562
Open ### 32563
Open ### 32564
Open ### 32565
Open ### 32566
Open ### 32567
Open ### 32568
Open ### 32569
Open ### 32570
Open ### 32571
Open ### 32572
Open ### 32573
Open ### 32574
Open ### 32575
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Open ### 32576
Open ### 32577
Open ### 32578
Open ### 32579
Open ### 32580
Open ### 32581
Open ### 32582
Open ### 32583 Merck
Open ### 32584
Open ### 32585 Merck
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Debbie O'Neill
Modify Existing Term
SDTM-POSITION
Scott Bahlavooni
Roche/Genentech
Create New Term
SDTM-UNIT
Debbie O'Neill
Create New Term
SDTM-POSITION
Open ### 32586 Merck
Open ### 32600 CDISC
Open ### 32601 CDISC
Open ### 32602 CDISC
Open ### 32603
Open ### 32604
Open ### 32605
Open ### 32606
Open ### 32607
Open ### 32608
Open ### 32609
Open ### 32610
Debbie O'Neill
Create New Term
SDTM-NCOMPLT
Bernice Yost
Modify Existing Term
SDTM-PKUNIT
Bernice Yost
Modify Existing Term
SDTM-PKUNIT
Bernice Yost
Modify Existing Term
SDTM-PKUNIT
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Open ### 32611
Open ### 32612
Open ### 32613
Open ### 32614
Open ### 32615
Open ### 32616
Open ### 32617
Open ### 32618
Open ### 32619
Open ### 32620
Open ### 32621
Open ### 32622
Open ### 32623
Open ### 32624
Open ### 32625
Open ### 32626
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-SPECIES
Audrey Walker
Charles River Labs
Create New Term
SEND-SPECIES
Audrey Walker
Charles River Labs
Create New Term
SEND-SPECIES
Audrey Walker
Charles River Labs
Create New Term
SEND-SPECIES
Audrey Walker
Charles River Labs
Create New Term
SEND-SPECIES
Audrey Walker
Charles River Labs
Create New Term
SEND-SPECIES
Open ### 32627
Open ### 32628
Open ### 32629
Open ### 32630
Open ### 32631
Open ### 32632
Open ### 32633
Open ### 32634 GSK Other
Open ### 32635
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Scott Bahlavooni
Roche/Genentech
Create New Term
SDTM-LOC
Scott Bahlavooni
Roche/Genentech
Create New Term
SDTM-LOC
Scott Bahlavooni
Roche/Genentech
Create New Term
SDTM-LOC
Rajinder Randhawa
GlaxoSmithKline
Modify Existing Term
SDTM-LBTESTCD
Randall Austin
SDTM-UNIT
Audrey Walker
Charles River Labs
Modify Existing Term
SDTM-LBTEST
Open ### 32636 Other
Open ### 32637
Open ### 32638
Open ### 32639
Open ### 32640
Open ### 32641
Open ### 32642
Open ### 32643
Audrey Walker
Charles River Labs
SEND-NEOPLASM
Audrey Walker
Charles River Labs
Create New Term
SEND-SPECIES
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-SPECIES
Audrey Walker
Charles River Labs
Create New Term
SEND-SPECIES
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Scott Bahlavooni
Roche/Genentech
Create New Term
SDTM-UNIT
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Open ### 32644
Open ### 32658 CDISC
Open ### 32660 Merck
Open ### 32661 Merck
Open ### 32662 CDISC
Open ### 32663
Open ### 32664 UCB, Inc.
Audrey Walker
Charles River Labs
Create New Term
SEND-STRAIN
Bernice Yost
Modify Existing Term
SDTM-NCOMPLT
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Debbie O'Neill
Create New Term
SDTM-LBTEST
Bernice Yost
Create New Term
SDTM-UNIT
Randall Austin
GlaxoSmithKline
Modify Existing Term
SDTM-LBTESTCD
Cliff Reinhardt
Modify Existing Term
QS-QSCAT
Open ### 32665 UCB, Inc.
Open ### 32666 Merck
Open ### 32674
Open ### 32675 BMS
Open ### 32676 CDISC
Open ### 32677
Open ### 32688 Merck
Open ### 32689 Merck
Cliff Reinhardt
Create New Term
QS-HAMA TESTCD
Debbie O'Neill
Create New Term
SDTM-LBTEST
Janice Hess
Modify Existing Term
SDTM-LOC
Cheryl Sloan
Create New Term
SDTM-LBTEST
Bernice Yost
Modify Existing Term
SDTM-UNIT
Audrey Walker
Charles River Labs
Create New Term
SEND-SPEC
Joyce hernandez
Create New Term
SDTM-DOMAIN
Colleen Bonjo
Create New Term
SDTM-LOC
Open ### 32690 Merck
Open ### 32691 Merck
Open ### 32692 Merck
Open ### 32693 Janssen
Open ### 32704 CDISC
Open ### 32705 QDS, Inc.
Open ### 32706 Takeda
Open ### 32707
Debbie O'Neill
Modify Existing Term
SDTM-RSSTRESC
Debbie O'Neill
Create New Term
SDTM-RSSTRESC
Colleen Bonjo
Create New Term
SDTM-PROCEDURE
Nik Pemble
Create New Term
SDTM-LBTEST
Bernice Yost
Modify Existing Term
SDTM-PKUNIT
Annette Inker
Modify Existing Term
SDTM-COUNTRY
Lorraine P. Spencer
Create New Term
SDTM-LBTEST
Monica Mattson
Celgene Corporation
Create New Term
SDTM-NCOMPLT
Open ### 32709 Merck
Open ### 32716
Open ### 32717
Open ### 32718
Open ### 32719
Open ### 32720
Open ### 32726 Amgen
Debbie O'Neill
Create New Term
SDTM-METHOD
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SEND-SPEC
Dan O'Connell
Modify Existing Term
SDTM-LOC
Open ### 32727 Amgen
Open ### 32728 Amgen
Open ### 32729
Open ### 32732
Open ### 32733 MSC Inc.
Open ### 32734 MSC Inc.
Open ### 32740 CDISC NEW
Dan O'Connell
Modify Existing Term
SDTM-POSITION
Dan O'Connell
Create New Term
SDTM-LBTES
Troy Smyrnios
Create New Term
SDTM-UNIT
Scott Bahlavooni
Roche/Genentech
Create New Term
SDTM-PKPARM
Erin Muhlbradt
Modify Existing Term
SDTM-VSTEST
Erin Muhlbradt
Modify Existing Term
SEND-OMTEST
Bron Kisler
Create New Codelist
Open ### 32741 Pfizer, Inc QS-OABQ
Open ### 32742 Covance
Open ### 32743 Merck
Open ### 32744 Lou Florio
Open ### 32745 Lou Florio
Roberta Rosenberg
Modify Existing Term
Phil Pochon
Create New Term
SDTM-METHOD
Debbie O'Neill
Create New Term
SDTM-TRTEST
Modify Existing Term
QS-COMM TEST
Modify Existing Term
QS-COMM TESTCD
Open ### 32749 gsk
Open ### 32750 gsk
Open ### 32761
Open ### 32762
Open ### 32763 Merck
Open ### 32764 Merck
claire west
Modify Existing Term
SDTM-LBTESTCD
claire west
Create New Term
SDTM-LBTESTCD
Audrey Walker
Charles River Labs
Modify Existing Term
SEND-NEOPLASM
Audrey Walker
Charles River Labs
Modify Existing Term
SEND-NEOPLASM
Debbie O'Neill
Create New Term
SDTM-LBTEST
Debbie O'Neill
Create New Term
SDTM-LOC
Open ### 32765 MSC Inc
Open ### 32766 MSC Inc
Open ### 32767
Open ### 32773
Erin Muhlbradt
Modify Existing Term
SDTM-FRM
Erin Muhlbradt
Modify Existing Term
SDTM-FRM
Audrey Walker
Charles River Labs
Create New Term
SEND-SPEC
Anna Pron-Zwick
AstraZeneca
Create New Term
SDTM-UNIT
Open ### 32774
Open ### 32775
Open ### 32776
Open ### 32777 Merck
Open ### 32778
Open ### 32784 Quintiles
Anna Pron-Zwick
AstraZeneca
Create New Term
SDTM-SPECTYPE
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc
Create New Term
SDTM-LBTESTCD
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc
Create New Term
SDTM-EGTESTCD
Debbie O'Neill
Create New Term
SDTM-RSSTRESC
Nate Freimark
Theorem Clinical Research
Create New Term
SDTM-DOMAIN
Gary Walker
Create New Term
SDTM-RACE
Open ### 32785 MSC Inc
Open ### 32786 CDISC NEW
Open ### 32787
Open ### 32796 Merck
Open ### 32797 CDISC Other New
Open ### 32798 Merck New
Open ### 32799 Merck New
Open ### 32800 CDISC QS-DAD
Erin Muhlbradt
Modify Existing Term
SDTM-LOC
Bernice Yost
Create New Term
Anna Pron-Zwick
AstraZeneca Pharmaceuticals
Create New Term
SDTM-MICROORG
Colleen Bonjo
Create New Term
SDTM-LOC
Rhonda Facile
Colleen Bonjo
Create New Codelist
Colleen Bonjo
Create New Codelist
Steve Kopko
Create New Term
Open ### 32801 Merck
Open ### 32802 Shire
Open ### 32803 Shire
Open ### 32804 Merck
Open ### 32805 MSC Inc.
Open ### 32808 Other
Open ### 32809
Open ### 32818
Colleen Bonjo
Create New Term
QS-QSCAT
Janet Siani
Create New Term
QS-QSCAT
Janet Siani
Create New Term
QS-QSCAT
Debbie O'Neill
Create New Term
SDTM-EGSTRESC
Erin Muhlbradt
Modify Existing Term
SDTM-LOC
Veronique Bourcier
Bayer Vital
SDTM-AGESPAN
Anna Pron-Zwick
AstraZeneca Pharmaceuticals
Create New Term
SDTM-PKPARM
Lorraine Spencer
Takeda Pharmaceuticals
Create New Term
SDTM-SPECTYPE
Open ### 32819
Open ### 32820
Open ### 32821 Chris Tolk CDISC
Open ### 32822
Open ### 32823 Covance
Open ### 32826 Shire
Open ### 32827 MSC
Kimberley Heron
Novartis Pharma AG
Modify Existing Term
SDTM-EGTEST
Diane Wold
GSK (but acting for the CDISC SDTM team)
Create New Term
SDTM-DOMAIN
Modify Existing Term
SDTM-DOMAIN
Audrey Walker
Charles River Labs
Create New Term
SEND-SSTYP
Phil Pochon
Create New Term
SDTM-MICROORG
Janet Siani
Create New Term
QS-QSCAT
Erin Muhlbradt
Modify Existing Term
SDTM-TSPARM
Open ### 32828 MSC
Open ### 32829 MSC
Open ### 32830 MSC
Open ### 32831 MSC
Open ### 32832
Open ### 32835
Open ### 32838 astellas
Open ### 32842 Merck
Erin Muhlbradt
Modify Existing Term
SDTM-LBTEST
Erin Muhlbradt
Modify Existing Term
SDTM-VSTEST
Erin Muhlbradt
Modify Existing Term
SDTM-PKPARM
Erin Muhlbradt
Modify Existing Term
SDTM-MICROORG
Veronique Bourcier
Bayer Vital
Create New Term
SDTM-TSPARMCD
Jenny Griffiths
Roche Products Ltd
Create New Term
SDTM-LOC
Cathy Bezek
Modify Existing Term
SDTM-LBTESTCD
Colleen Bonjo
Create New Codelist
SDTM-LOC
Open ### 32843 Merck
Open ### 32844 MSC
Open ### 32845
Open ### 32846
Open ### 32847
Open ### 32848
Colleen Bonjo
Create New Term
SDTM-LOC
Erin Muhlbradt
Modify Existing Term
SDTM-EGSTRESC
Jozef Aerts
Modify Existing Term
SDTM-UNIT
Jozef Aerts
Modify Existing Term
SDTM-UNIT
Jozef Aerts
Modify Existing Term
SDTM-UNIT
Monika Paliwal
www.bioclinica.com
Create New Term
SDTM-VSTESTCD
Open ### 32849 CDISC
Open ### 32851 MSC
Open ### 32852 MSC
Open ### 32853 MSC
Steve Kopko
Create New Term
QS-UPDRS TEST
Erin Muhlbradt
Modify Existing Term
SDTM-EGSTRESC
Erin Muhlbradt
Modify Existing Term
SDTM-EGSTRESC
Erin Muhlbradt
Modify Existing Term
SDTM-EGSTRESC
Open ### 32854
Open ### 32855 CDISC New
Open ### 32856 Merck
Open ### 32857
Open ### 32858 Merck
Open ### 32859 Merck
Open ### 32860
Randall Austin
GlaxoSmithKline
Create New Term
SDTM-EGSTRESC
Steve Kopko
Create New Codelist
Colleen Bonjo
Create New Term
SDTM-LOC
Harsh Marwaha
Ekagra Software
Create New Term
SDTM-TSPARMCD
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Create New Term
SEND-NEOPLASM
Open ### 32861 Merck
Open ### 32862 Merck
Open ### 32863 Merck
Open ### 32864 Merck
Open ### 32865 Merck
Open ### 32866 Merck
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Open ### 32867 Merck
Open ### 32868 Merck
Open ### 32874 Jordan Li NCI EVS
Open ### 32875 Jordan Li NCI EVS MULTIPLE
Open ### 32876
Open ### 32877
Open ### 32878
Open ### 32879
Open ### 32880
Open ### 32885
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Benjamin Sefing
Create New Term
SEND-NEOPLASM
Modify Existing Term
QS-CSSRS Baseline TEST/CD
Modify Existing Term
Audrey Walker
Charles River Labs
Create New Term
SEND-SPEC
Audrey Walker
Charles River Labs
Create New Term
SEND-NEOPLASM
Audrey Walker
Charles River Labs
Create New Term
SEND-SPEC
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River Labs
Create New Term
SDTM-LBTEST
Amy Klopman
Roche/Genentech
Create New Term
SDTM-LOC
Open ### 32886
Open ### 32887
Open ### 32888
Open ### 32894
Open ### 32895 Luc Dekie
Open ### 32896
Amy Klopman
Roche/Genentech
Create New Term
SDTM-METHOD
Elizabeth Langevin
The Takeda Oncology Company
Modify Existing Term
SDTM-NYHAC
Audrey Walker
Charles River Laboratories
Modify Existing Term
SEND-DESIGN
Lorraine Spencer
Takeda Pharmaceuticals
Create New Term
SDTM-LOC
Biomedical Systems
Create New Term
SDTM-EGSTRESC
Audrey Walker
Charles River Labs
Create New Term
SEND-SSTYP
Open ### 32897 Merck
Open ### 32908 Merck
Open ### 32909 Merck
Open ### 32910 Merck
Open ### 32911 MSC
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-LOC
Debbie O'Neill
Create New Term
SDTM-SPECTYPE
Erin Muhlbradt
Create New Term
SDTM-SPECTYPE
Open ### 32912 Instem
Open ### 32913 Instem
Open ### 32914 C-Path
Open ### 32926
Open ### 32927
Open ### 32928
Open ### 32929
Open ### 32930 Other None
Jennifer Feldmann
Create New Term
SEND-SPEC
Jennifer Feldmann
Create New Term
SEND-SPEC
Bess LeRoy
Create New Term
SDTM-LOC
Amy Klopman
Genentech/Roche
Create New Term
SDTM-TRTESTCD
Carrie Neeley
Covance Laboratories
Create New Term
SDTM-ROUTE
Carrie Neeley
Covance Laboratories
Modify Existing Term
SDTM-ROUTE
Carrie Neeley
Covance Laboratories
Modify Existing Term
SDTM-FREQ
Anna Pron-Zwick
AstraZeneca Pharmaceuticals
Open ### 32931 MSC
Open ### 32945 Shire
Open ### 32946
Open ### 32947
Open ### 32948
Open ### 32949
Open ### 32950
Open ### 32951
Open ### 32952 C-Path
Erin Muhlbradt
Modify Existing Term
SDTM-SIZE
Janet Siani
Modify Existing Term
SDTM-SPECCOND
Amy Klopman
Genentech/Roche
Create New Term
SDTM-METHOD
Kapila Patel
Novartis Pharma
Create New Term
Kapila Patel
Novartis Pharma
Create New Term
SDTM-EGMETHOD
Kapila Patel
Novartis Pharma
Create New Term
SDTM-UNIT
Kapila Patel
Novartis Pharma
Create New Term
SDTM-LOC
Kapila Patel
Novartis Pharma
Create New Term
SDTM-UNIT
Bob Stafford
Create New Term
QS-NPI TEST
Open ### 32953
Open ### 32956 Other
Open ### 32957 MSC
Open ### 32958
Joyce Hernandez
Create New Term
SDTM-RSSTRESC
Abhishek Dabral
Forest Labs
SDTM-NCOMPLT
Erin Muhlbradt
Modify Existing Term
SDTM-TSPARM
Kapila Patel
Novartis Pharma
Create New Term
SDTM-EGTEST
Open ### 32972
Open ### 32973
Open ### 32974
Open ### 32983 CDISC Multiple
Open ### 32984 CDISC Multiple
Open ### 32985 CDISC
Open ### 32986 Other
Open ### 32987
Open ### 32988 MSC
Sabina Hussain
Charles River Laboratories
Create New Term
SEND-MTHTRM
Gary Cunningham
Teva Pharmaceuticals
Create New Term
SDTM-QS COWS TESTCD
Gary Cunningham
Teva Pharmaceuticals
Create New Term
SDTM-QS COWS TESTCD
Bernice Yost
Create New Term
Bernice Yost
Create New Term
Amy Palmer
Create New Term
SDTM-EGTEST
Rostgaard Stender
H. Lundbeck. A/S
SDTM-EGSTRESC
Audrey Walker
Charles River
Create New Term
SEND-SPEC
Erin Muhlbradt
Modify Existing Term
SEND-SPEC
Open ### 32989 MSC
Open ### 32992 Pfizer
Open ### 32993 CDISC Multiple
Open ### 32994
Open ### 32995 Merck NEW
Open ### 32996 MSC Multiple
Open ### 32997 CDISC
Open ### 32998 CDISC
Open ### 32999 MSC
Open ### 33000
Open ### 33005 CDISC Multiple
Erin Muhlbradt
Modify Existing Term
SEND-MTHTRM
Roberta Rosenberg
Modify Existing Term
QS-NPI TEST
Bernice Yost
Modify Existing Term
Audrey Walker
Charles River
Create New Term
SDTM-LBTESTCD
Colleen Bonjo
Create New Codelist
Erin Muhlbradt
Modify Existing Term
Bernice Yost
Create New Term
SDTM-UNIT
Bernice Yost
Create New Term
SDTM-SPECCOND
Erin Muhlbradt
Modify Existing Term
SEND-NEOPLASM
Randall Austin
GlaxoSmithKline
Modify Existing Term
SDTM-LOC
Bernice Yost
Modify Existing Term
Open ### 33006
Open ### 33007
Open ### 33008 CDISC
Open ### 33009 Multiple
Open ### 33010 UCB, Inc.
Open ### 33011
Open ### 33012
Open ### 33013 CDISC Multiple
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
SDTM-LBTESTCD
Kapila Patel
Novartis Pharma
Create New Term
SDTM-LOC
Bernice Yost
Create New Term
SDTM-LBTEST
Lakshmi Mallela
Johnson and Johnson
Modify Existing Term
Cliff Reinhardt
Create New Term
QS-MDS-UPDRS TESTCD
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
SDTM-UNIT
Bess LeRoy
Create New Term
SDTM-SCTEST
Steve Kopko
Create New Term
Open ### 33014 Merck Merck
Open ### 33015 Merck
Open ### 33016 Merck
Open ### 33017 CDISC New
Joyce Hernandez
Modify Existing Term
SDTM-DOMAIN
Joyce Hernandez
Modify Existing Term
SDTM-DOMAIN
Debra O'Neill
Create New Term
SDTM-UNIT
Bernice Yost
Create New Codelist
Open ### 33018 None
Open ### 33019
Lacey Wallace
Eli Lilly and Company
SDTM-EGSTRESC
Lacey Wallace
Eli Lilly and Company
Modify Existing Term
SDTM-EGMETHOD
Open ### 33020
Open ### 33021
Open ### 33022
Open ### 33023 CDISC
Open ### 33024 CDISC SDTM-NY
Audrey Walker
Charles River
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River
Create New Term
SEND-NEOPLASM
Carrie Neeley
Covance Labs
Create New Term
SDTM-LBTEST
Bernice Yost
Modify Existing Term
SDTM-STENRF
Bernice Yost
Modify Existing Term
Open ### 33025 CDISC
Open ### 33026 CDISC
Open ### 33027 CDISC
Open ### 33028 CDISC
Open ### 33030 Instem
Open ### 33031 CDISC Multiple
Open ### 33032 CDISC Multiple
Open ### 33033 MSC
Open ### 33034 CDISC
Open ### 33035 CDISC Multiple
Open ### 33036 CDISC
Open ### 33044 CDISC Multiple
Bernice Yost
Modify Existing Term
SDTM-SEX
Bernice Yost
Modify Existing Term
SDTM-CVPRCIND
Bernice Yost
Create New Term
SDTM-UNIT
Bernice Yost
Create New Term
SDTM-UNIT
Jennifer Feldmann
Modify Existing Term
SEND-NEOPLASM
Bernice Yost
Modify Existing Term
Bernice Yost
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
SEND-SSTYP
Bernice Yost
Modify Existing Term
Bernice Yost
Modify Existing Term
Bernice Yost
Modify Existing Term
SDTM-LBTEST
Bernice Yost
Modify Existing Term
Open ### 33045 Other
Open ### 33046 Multiple
Open ### 33047
Open ### 33048
Open ### 33049 Merck
Open ### 33052 Merck
Lacey Wallace
SDTM-PROCEDUR
Carol Detrisac
Charles Liver
Modify Existing Term
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
SDTM-LBTESTCD
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
SDTM-LBTEST
Debbie O'Neill
Create New Term
SDTM-MICROORG
Colleen Bonjo
Create New Term
SDTM-UNIT
Open ### 33053 Celgene
Open ### 33054
Open ### 33055 CDISC
Open ### 33056 CDISC
Eileen Gardenhire
Create New Term
SDTM-SPECTYPE
Jane Diefenbach
PharmaStat LLC
Create New Term
SDTM-SPECTYPE
Steve Kopko
Create New Term
QS-CDR TEST
Robert Dempsey
Create New Term
SDTM-EGMETHOD
Open ### 33057 Sunovion
Open ### 33058 Merck
Open ### 33059 Merck
Open ### 33060 Merck
Open ### 33061 Merck
Open ### 33062 Multiple
Open ### 33066 Merck
Guy Genereux
Modify Existing Term
SDTM-EGTEST
Debbie O'Neill
Create New Term
SDTM-LBTEST
Debbie O'Neill
Create New Term
SDTM-UNIT
Debbie O'Neill
Create New Term
SDTM-METHOD
Debbie O'Neill
Create New Term
SDTM-CVEXAM
Emily Hartley
Critical Path Institute
Create New Term
Colleen Bonjo
Create New Term
SDTM-CVEXAM
Open ### 33072
Open ### 33073 New
Open ### 33074
Open ### 33075
Open ### 33076
Open ### 33077
Open ### 33080
Open ### 33081 Multiple
Open ### 33082 New
Mary Jo Brucker
Merck & Co.
Create New Term
SEND-SPEC
Mary Jo Brucker
Merck & Co.
Create New Codelist
Saloni Shah
Chiltern Intl.
Modify Existing Term
SDTM-NCOMPLT
Carrie Neeley
Covance Labs
Create New Term
SDTM-LBTEST
Audrey Walker
Charles River
Modify Existing Term
SDTM-LBTEST
Audrey Walker
Charles River
Create New Term
SDTM-LBTEST
Bess LeRoy
Modify Existing Term
SDTM-LOC
Peggy Zorn
Modify Existing Term
Peggy Zorn
Create New Codelist
Open ### 33083 Other
Open ### 33084 Other
Open ### 33085
Open ### 33086
Gitte Frausing
SDTM-LBTEST
Erin Muhlbradt
SDTM-DOMAIN
Audrey Walker
Charles River
Create New Term
SDTM-LBTEST
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals Inc
Create New Term
SDTM-UNIT
Open ### 33092
Open ### 33093 Merck
Open ### 33094 Shire New
Open ### 33099 Merck
Open ### 33100
Open ### 33101
Open ### 33102 MSC Inc
Carrie Neeley
Covance Labs
Create New Term
SDTM-LBTEST
Debra O'Neill
Create New Term
SDTM-LOC
Janet Siani
Create New Codelist
Debra O'Neill
Create New Term
SDTM-LOC
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
SDTM-UNIT
Jane Diefenbach
NIAID/DAIDS and PharmaStat LLC
Create New Term
SDTM-SPECTYPE
Erin Muhlbradt
Modify Existing Term
SDTM-MICROORG
New Term or Codelist/Existing Term or Code Number
See Attached File
Immunoblastic Lymphocytes/Lymphocytes
New MICROORG terms
Please add synonym for C96603 EBNAB; Synonym proposed is Epstein-Barr Nuclear Antigen Antibody
EBNA1IGG - Epstein-Barr Nuclear Antigen 1 IgG Ab OR EBN1IGAB - Epstein-Barr Nuclear Antigen 1 IgG Ab
Change submission value "CB6F1-TgN (RasH2)" to "CByB6F1-Tg(HRAS)2Jic" for Code C98711.
Add "Hemoglobin Distribution Width" to SEND LBTEST. Corresponding LBTESTCD would be needed.
STEPS; BLOCKS
PELVIC BONE
Total Immunoglobulins
Definition correction for C74683 CYTYRO Tyrosine Crystals
Is it possible, now that there are more synonyms for each LBTESTCD, to make the first synonym for any LBTESTCD correlate to the controlled term in LBTEST?
Please see the attached list of terms for addition to the LB domains.
Please add the option Phase 1b Trial to the list as we have had a number of trials denoted as 1b recently
Please modify the definitions associated with the following TESTCD - and associated TEST values:
Definitions do not match the questionnaire exactly. Review requested by the QS Terminology team.
Intra corpus cavernosum; Intracervical; Intrahepatic; Subdermal; Transmammary
DF (Dosage Form Unit of Measure)
C66957
The codelist name is too long, Should be 8 characters.
Addition of Domain codes
ERMAX and ERLST: please add the following to the existing definitions at the end of the definition. "...determined for the specimen type specified in PPSPEC"
Reserve a New Domain Code for Pharmacogenomics (PGx) caled PT
Parkinson;s Disease v1.0 Standards controlled terminology updates based on CDISC SRC approval of provisional PD User Guide on 20-Dec-12. I have sent and reviewed the CT spreadsheet with Bernice Yost that covers the either new terms updates
kHz: A unit of measure denoting the frequency equal to 1000 cycles per second meaning e.g. that the cylical waveform changes from one state to the other (from one polarity to the other) 1000 times per second.
Catheter - Route
Catheter- Method
Fascia (Fascia of the foot)
ASPIRATION
There are two method that reference x-rays - C38101 (XRAY) and C85830 (X-RAY FLUORESCENCE SPECTROMETRY)
Update definition for RS: The RS domain represents the response evaluation determined from the data in the TR domain or data from other sources (i.e. other SDTM domains) for example, lab test results (LB) or symptoms.
ADLB has been assigned many different SAS labels at our company. I suggest concatenating the C667234 CDISC synonym values LB (Laboratory Data) and AD (Analysis Dataset) to create ADLB (Laboratory Data Analysis Dataset). This could work for all combination
"Macrophages" absolute and percentage
"Amplitude"
PPTESTCD: AUCPBEO
Please consider changing the LBTEST for SDTM and SEND for "Erythrocytes Distribution Width" to "Red cell distribution width" please see justification from our Scientists below...
Please consider adding LBTEST, LBTESTCD "Monocytes/Macrocytes" absolute and percent tests please.
Please consider adding LBTEST, LBTESTCD "Agglutination"
Alpha Hydroxybutyrate Dehydrogenase/&#945;-HBDH
PPTEST: AUC %Back Extrapolation Obs
"Volume Wash"
"Bb Fragment of Factor B"
"Butyl Cholinesterase"
"C-Reactive Protein High Sensitivity"
"Corpuscular Hemoglobin Content Gated"
"Meningeal Cell"
"Meningeal Cell" for absolute and percent
"Monocytoid Cell" for absolute and percent
Please consider adding a new LBTEST and LBTESTCD for the following term:"Mast Cell" absolute and percentage
Here is a list of 21 - Lilly Methods codes that we would like to be included into CDISC terms.
Please consider adding a new LBTEST and LBTESTCD for the following term: "Surfactant D"
Please consider adding a new LBTEST and LBTESTCD for the following term: Chymotrypsin
"Corpuscular Hemoglobin Concentration Mean Gated"
"Degenerated Cells"
&quot;Curve Type&quot;
&quot;Mean Amplitude&quot;
&quot;Mean Curve Type&quot;
&quot;Heinz Bodies&quot; percent
&quot;Immature Cells&quot; percent
&quot;Platelet Aggregation&quot; Percent
&quot;Platelet Activating Factor&quot;
&quot;Thrombocyte Count&quot;
&quot;Vacuolated Lymphocytes&quot;
&quot;Troponin&quot;
&quot;Pi Glutathione-S-Transferase&quot; - GSTPI
&quot;Content of Hemoglobin-Bound Oxygen&quot;
&quot;Cytoplasmic Basophilia Neutrophil&quot;
&quot;Glycosylated Hemoglobin&quot; percent
&quot;Platelet Component Distribution Width&quot;
&quot;Total Ketone Bodies&quot;
&quot;Packed Cell Volume&quot; - PCV
&quot;Nuclear Swelling
&quot;Mean Platelet Dry Mass&quot;
&quot;MCV Reticulocytes&quot;
&quot;Iron Saturation&quot; Percent
Semi-Recumbent
DECUBITUS
&quot;Thyroid Stimulating Hormone&quot; - TSH
Please add mmol/mol to the SDTM-UNIT code list. This is the new SI Unit for HBA1c
Please consider adding the following STRAIN: HOUND
Please consider adding the following STRAIN: domestic
CYNOMOLGUS INDONESIA
CYNOMOLGUS MAURITIUS
CYNOMOLGUS PHILLIPINES
SUBJECT DISCONTINUED DUE TO CAREGIVER WITHDRAWAL
C85628 h*ng/mL/mg/kg please add parenthesis h*ng/mL/(mg/kg)
C85629 h*ng/mL/mg/m2 please add parenthesis h*ng/mL/(mg/m2)
C85748 ng/mL*kg please remove this unit code, this request is from the PK terminology team.
Please consider adding the following STRAIN: CYNOMOLGUS CAMBODIAN
Please consider adding the following STRAIN: CYNOMOLGUS CHINA
Please consider adding the following STRAIN: CYNOMOLGUS INDIA
CYNOMOLGUS PORT DOWN UK
CYNOMOLGUS
RHESUS CHINA
RHESUS INDIA
RHESUS INDONESIA
RHESUS PHILIPPPINES
RHESUS PORT DOWN UK
RHESUS VIETNAM
NEW ZEALAND WHITE
UK
Dog Juvenile
Hamster Juvenile
Monkey Juvenile
Mouse Juvenile
Rabbit Juvenile
Rat Juvenile
NEW ZEALAND BLACK
NEW ZEALAND RED
NEW ZEALAND HYBRID
Please add OPTIC DISC to the LOC code list.
Please add ANTERIOR VITREOUS to the LOC code list.
Please add EYE, ANTERIOR CHAMBER to the LOC code list.
Update the CDISC Submission Value for LBTESTCD from APPTLAS to APTTLAS. The associated LBTEST has been updated but not the LBTESTCD.
Request guidance on use of "/sec" versus "/s"
Please remove the word blood and replace with biological in the definition of Blood Urea Nitrogen - BUN
hair follicle tumors
NEW ZEALAND
NEW ZEALAND in STRAIN codelist
MOUSE
RAT
FATHEAD
NOD.SCID
Please add Hounsfield Unit to the UNIT code list. Needed for tumor assessments
LISTER HOODED
LYSATE
Can this please be changed to "Failure to meet enrollment criteria" since not all studies have randomization.
Cyclic Guanosine 3,5-Monophosphate with the test code CGMP
Submission Value = PULSE ; Synonyms = Pulse Dosing Unit; Pulses Dosing Unit; Definition = A dosing measurement based on the pulse unit.
LBTESTCD HIVIMONA, HIVIOAB, HIVI24AG - the 4th character in the code value should be a 'one'?
Code C102118 submission value is: HAMA. Request this updated to HAM-A with the dash between the M and 2nd A.
Consider adding a HAM-A total score.
Add new terms to SEND-SPEC
PS - PROTOCOL SUMMARY for PGx
PERIANAL and PERIURETHRAL
Unspecified Cells with Test Code: UNSPCELL; Test Name: Bronchial Epithelial Cells with Test Code: EPIBRON
Change 'CORONARY ARTERY, ANTERIOR DESCENDING' to 'LEFT CORONARY ARTERY, ANTERIOR DESCENDING'.
Please see the attached list of terms for addition to the LB domains.
Definition for pH: The negative logarithm (base 10) of the concentration of hydrogen ions expressed in moles per liter, which is used as a measure of the acidity or alkalinity of a fluid.
Update Cri to CRi
File of 9 new terms for Procedure codelist
COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY
Please add a lab test for Alpha-1 Antichymotrypsin with a proposed test code of A1ANCHTR
C64387, mmol/L, The PK Terminology team would like to request that the definition be changed to: A unit of concentration (molarity unit) equal to one millimole of solute per one liter of solution.
These three synonyms are inconsistent with ALL other countries in the synonym list.
All the requests are for new items in the SDTM LBTEST / LBTESTCD lists
Add new term "SYMPTOMATIC DETERIORATION"
DEXA SCAN
Please consider adding the following terms
Eosinophils Band Form
Reticulocyte Distribution Width
Please consider adding the following LBTEST, LBTESTCD:
Abdominal Cavity and Abdomen
Please consider adding the following term for SPEC: Cheek Pouch
Semi-Recumbent
BISCUIT
C25208-WEIGHT/Weight
C25208-WEIGHT/Weight in OMTEST
Codelists for Education Status and Employment Status
At Amgen, we have gone through our lab analytes and compared them to CDISC equivalent terms. The attached spreadsheet lists out all terms for which we feel there is no CDISC equivalent.
Please add new terms: PKPARMCD = VZ, PKPARM = Vol Z; PKPARMCD = VZF PKPARM = Vol Z by F
C103671 OABQ0119
New Methods from Phil Pochon
Slice Thickness (Test Code: SLTHKT; Percent Change Sum Diameters From Bsln (Test Code: PCHSDBL); Percent Change Sum Diameters From Nadir (Test Code: PCHSDNAD)
(Code C100764) Questionairre Category for Current Opioid Misuse Measure (COMM)is inconsistent with COMM Test Codes, according to QS term rules. Suggest change COMM to COMM1.
Existing term is inconsistent with all other terms for this questionnaire. Code=C105288, Submission Value="ADL106". All other terms use the prefix �ADL01�. Either change this term to "ADL0106" or change the prefix to �ADL1� for all other Tests
APTTSTND and APTTSPTT
Measles vs Rubeola
Sialyl SSEA-1 Antigen - Test Name
PLEURA
C84537 - ADENOMA, YOLK SAC, BENIGN should be renamed to YOLK SAC TUMOR, BENIGN to be harmonized/align with C3011 YOLK SAC TUMOR, MALIGNANT.
C2797 - ADENOMA, ACINAR CELL, BENIGN and C2798 ADENOMA, ADNEXAL, BENIGN both have the exact same definition.
Torr
FDA is removing the following dosage forms from its SPL list: BEAD, IMPLANT, EXTENDED RELEASE; BLOCK; CEMENT; CIGARETTE; CONE; CORE, EXTENDED RELEASE; CULTURE; GENERATOR; GRAFT; GUM; GUM, RESIN; LINER, DENTAL; PACKING; SUTURE; UNASSIGNED; DIAPHRAGM.
Remove (FDA) attribution from 56 terms in the Dosage form codelist.
Please consider adding the following Avian specimen: BURSA OF FABRICIUS, CROP, PROVENTRICULUS, SYRINX, VENTRICULUS
Lysate
LBALL
EGALL
sCR; HI-E; HI-N; HI-P; mCR
AX
MULTIPLE and OTHER
C32497
File emailed separately
SUBCUTANEOUS
CFAST ASTHMA TA Terminology
QS-SF36 which represent the Heath Survey
New DAD questions
Asthma Devices: Spirometer, Peak Flow Meter, Nebulizer
QS-MDQT which represent the Menstrual Distress Questionnaire (Form T - Today)
ADHD-RS
SDS
Change c-code - Duplicate concepts merged in NCIT
File emailed separately
Please add a type for capillary blood.
QS-DLQI which represents the Dermatology Life Quality Index
Type 1 2nd degree AV Block; Type 2 2nd degree AV Block
AGESPAN is currently not in 2013-04-12 version of SDTM controlled terminology but still in TSPARMCD codelist. Will the AGESPAN list be put back in next version?
SR and IS Domain codes
Domain code definitions.
ADME
New Bacteria terms in Covance dictionary
MADRS
Summary (mean) PR duration - correct to PR Interval; Summary (mean) QT duration - correct to QT Interval; EGCAT should also be 'duration' and not interval; RR should also be Interval
TSPARM and TSPARMCD codelists have identical definitions.
STRATFCT
Addition to Anatomical Location NCI C74456
OCCBLD - The definition is unclear
NERVE
LBTEST and LBTESTCD codelists have identical definitions.
VSTEST and VSTESTCD codelists have identical definitions.
AURC to Last Nonzero Rate (C85571) and AURC All (C85841) in the PKPARM and PKPARMCD codelists have the same definition.
C85639 and C86594 in the Microorganism codelist have the same definitions.
MUSCLE
U Wave Abnormality
pH
BEATS/MIN
BAR
All above TESTCD fields are not present currently in VS domain. File emailed separately.
C50800
C102591
C71066
Additional SDTM QSTESTS based on the GRID portion of the UPDRS CRF
Please add the following result terms to the list
Modified Rabkin Scale QS Terminology
File emailed separately
Add: Schwannoma, malignant
Add: Neurofibrosarcoma, malignant
Add: Polyp, Benign
STRATFCT Stratification Factor. Stratification factor is referred in the SDTM Implementation Guide but it is not included in the SDTM code list.
Add: Mesenchymal tumor, malignant
Add Nephroblastoma, benign
Add Trichoepithelioma, malignant
Add: Melanoma, benign
Add Carcinoid tumor, malignant or revise current term to remove atypical.
Revise Carcinoid tumor, undetermined to become Carcinoid tumor, benign.
Revise the leukemias to take off the word Acute
Add: Granulosa Cell tumor, benign
Codelist Code: C100167
Please consider adding the following new terms
OMENTUM
Need to change CDISC Definition for an recurring question in 4 C-SSRS questionnaires. Please see attached file for details and change suggestions.
Please consider adding the following new term; BONE, CARPAL OR BONE, CARPUS
Please consider adding the following terms: bulbocavernosus, levator ani, levator ani/bulbocavernosus
Please consider adding LBTEST, LBTESTCD &quot;Monocytes/Macrocytes&quot; percent tests please.
Please consider adding LBTEST, LBTESTCD "Monocytes/Macrocytes" percent tests please.
MULTIPHASE CT SCAN
Please add abdomen
Tumorigenicity and Oncogenicity
New York Heart Association Class Responses (codelist NYHAC)
Please can you review the definitions for BLOCKED; PARALLEL; PARTIALLY BLOCKED BALANCED
considering that we have a code for QTcB and QTcF prolongation, it should also be considered adding a code QTcB and QTcF shortening besides the currect QTc shortening code.
HEMISPHERE, RIGHT and HEMISPHERE, LEFT
STRIATUM
PRECUNEUS; STRIATUM (Synonym: NEOSTRIATUM)
DRIED BLOOD SPOT
Skin
TRTESTCD = 'PAXIS' (TRTEST = 'Perpendicular Axis')
PERIVENOUS
Other
Other in SDTM-FREQ
Add Field to Capture Virus Strain
A controlled term for in the SEND SPEC list is needed for Tympanic Bulla. This concept is shown in the nci metathesarus as a snomed preferred term. We have a client who does gross observations on this tissue, and we need an appropriate SPEC entry for i
A controlled term for Ocular in the SEND list is needed for Ocular adnexa. This concept is shown in the nci metathesarus as a snomed synonym. We have a client who does gross and micro observations on this tissue, and we need an appropriate SPEC entry f
Two new terms: 1. L2-L3 Intervertebral Space 2. L3-L4 Intervertebral Space
LARGE - Edit to definition
HEMOLIZED
Add MRI WITHOUT CONTRAST
Foot-pound
MOBILE CARDIAC TELEMETRY
umol/min
Medial femoral condyle; Lateral humeral epicondyle
mmol/mmol
Additional terms for NPI Scoring fields
INDIC/Trial Indication
Add ND- No Disease ( this is not part of any criteria); Add NN and IR/SDas synonym to NonCR/NonPD
difference between Protocol Deviation, Important Protocol Deviation and Protocol Violation
Attached file consists information for multiple term request for EGTEST codelist.
Add QSTESTCD = COWS101A
Abnormality
Code C71043 from Codelist C71150
Proventriculus
GIZZARD
BARBITURATE OVERDOSE INTRAVENOUS AND EXSANGUINATION
Add a QSTESTCD for the total score that is collected on the questionnaire.
PK Terms for Package 15 - please see attached spreadsheet
PK Terms for Package 16 - please see attached spreadsheet
C90400; C90401
Oncology_Modify_Term_Request_Package16
copies/5uL; LOG10 IU/mL
C98800
'Butterflies' misspelled in Submission and Synonym values for NPITEST (Code=C100662) and for the Synonym value for NPITESTCD (NPI1E04)
Please consider the following LBTEST/CD: Sulfur Dioxide - SO2
Non-Measureable Assessment Response = Terminology relevant to the test codes that describe an assessment of non-measurable response to treatment or therapy.
C111335; C111336; C111337; C111338; C111339; C111340
FRESH - definition: Not previously used.; PARAFFIN-EMBEDDED - definition: Pertaining to being preserved in paraffin.
INTERPHALANGEAL JOINTs and PROXIMAL INTERPHALANGEAL JOINT
The Submission Values and Synonyms do not follow the QS Naming Rules. I have sent a file to the above email address.
CYLCELL
Multiple term request.
Vital Signs Test Code
mmol/mol HGB
Dominant Hand
CV Endpoints Data Standards Controlled Terminology
Hemoglobin A1C/Total Hemoglobin: A relative measurement (ratio or percentage) of the glycosylated hemoglobin to total hemoglobin in a biological specimen.
UPD2315B (Test value=UPD2-Postural Tremor of Left Hand) and UPD2316A (Test value=UPD2-Kinetic Tremor of Right Hand)
SL Domain
mg/mL/min
DOMAIN codelist for SDTM. Replace SR domain with SK domain which is already in the Terminilogy released in June, 2013. Make sure that the description for the SK domain is broad enough to collect all types of findings for skin.
Protocol Milestone Codelist: two entries - Informed Consent Obtained and Randomized
Please consider adding the terms
Pancreatic Lipase
benign acinar-islet cell tumor; ASTROCYTOMA, BENIGN; GRANULOSA CELL TUMOR, BENIGN; OLIGODENDROGLIOMA, BENIGN; SCHWANNOMA, MALIGNANT; polyp, benign; EPENDYMOMA, BENIGN; chordoma, benign; Plasma cell tumor, malignant
Change the submission value to UNKNOWN for C17998 in STENRF
Change the submission value to UNKNOWN for C17998 in NY
Please see attached spreadsheet.
CDASH should match SDTM exactly.
C90003
I have attached a spreadsheet.
Change the submission value to UNKNOWN for C17998 in SEX
Change the submission value to UNKNOWN for C17998 for CVRPCIND
dpm, disintegrations per minute, A unit of radioactive decay expressed in atoms of radioactive material that decay over a period of time equal to sixty seconds. (NCI)
pixel; The smallest resolvable rectangular area of an image, either on a screen or stored in memory.
C9477 has an extra space before the comma in the second part of the term: ASTROCYTOMA, ANAPLASTIC , MALIGNANT
C45908 The submission value of UN should be changed to Undifferentiated.
"Trial Phase Codelist - NA should be NOT APPLICABLE C48660; No Yes Response Codelist - NA should be NOT APPLICABLE; Tumor Response Result Codelist - NA should be NOT APPLICABLE
There are two codelists with the same name of Study Type. The codelists names should be changed to SDTMIG Study Type and SEND Study Type.
CMTRT
IL28BGEN
IL28B Genotype
MICROORG File Emailed Separately
cells/kg
MEDIAL and LATERAL should be on same codelist. Currently on is on the laterality codelist and one is on the directionality codelist.
ERYTHROCYTES
BACTERIAL ISOLATE
CDR0109 CDR01-Behavior Component and Personality; CDR0110 CDR01-Langiage Clinical Dementia Rating - Language
Please add 'Intentional right sided leads'. This request comes from the ECG terminology team
mV^2/Hz
ELECTROENCEPHALOGRAPHY and POLYSOMNOGRAM
It appears that the new EGTEST Submission Values added in the 10/4/2013 release are actually EGTESTCD values. They shouldbe updated with the long text 'decode' values.
Cholera Toxin B Subunit IgG Antibody (TESTCD: CTBIGGAB)
CVEXAM and CVEXAMCD additions will be sent via an excel file.
These terms come from the examples used in the Alzheimer’s Disease User Guide v2
Multiple term request for CVEXAM and CVEXAMCD codelists
FAILURE TO MEET RANDOMIZATION CRITERIA
Please modify the Submission term for: C111283
Suggested new SPEC terms for Repro Tox (Fetal Gross Pathology):
New Codelist: "Nonclinical DART Trial Phases" (NCDPHASE)
Add Percent Iron Saturation to LBTEST and corresponding test code FESATP for SEND. Proposed definition would be: A relative measurement (ratio or percentage) of total iron binding sites occupied by iron in a biological specimen.
Please consider adding the following term: RBC Fragment (Other)
Please remove "MUSCLE, DISTAL" and "MUSCLE, PROXIMAL" as distal and proximal should go in --DIR
With SEND 3.1, the CV and RE domains will be published. When that happens, we would like to remove the VSUNIT, VSTEST and VSTESTCD codelists from the SEND terminology.
We would like to add 2 SEND specific VS codelists, one for VSTEST and one for VSTESTCD that only reference the TEMPERATURE/TEMP term (as published with the existing SDTM codelist).
SDTMIG Domain Abbreviation
Myeloperoxidase Index
/10^3 RBC
Combinations of CD markers are not yet included in CDISC CT
Tartrate-Resistant Acid Phosphatase 5b
SOFT TISSUE
mJoule/cm2
Peritoneal Fluid; Pericardial Fluid
Change c-code: From C26431 to C113205.
SKIN OF THE HEAD, SKIN OF THE NECK, SKIN OF THE AXILLA
Add to QSCAT codelist, C-SSRS Pediatric/Cognitively Impaired Lifetime/Recent
Detailed Description
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See Attached File III
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2012 Q3 and Q4 updates to Covance Microorganism dictionary III
Change Type
I guess there may be some lack of granularity in the term above. I guess it can be used for EBNA antibodies when the immunoglobin is not known or stated and when the EBNA subtype is not known. Typically now I see serology specific for EBNA1 IgG. I am going to write a separate request for this
Additional granularity on EBNA supported by recent research articleshttp://www.wjgnet.com/2220-3249/full/v1/i1/31.htmand assay product insertshttp://www.medac.de/medac_international/data/diagnostics/brochures/EBV%20Flyer_Homepage.pdf
Please consider adding the term "Immunoblastic Lymphocytes/Lymphocytes". CDISC Controlled Terminology already has the term "Lymphocytes, Immunoblastic" and there is also a term to capture "Plasmacytoid Lymphocytes/Lymphocytes". We require a term to capture the relative measurement of Immunoblastic Lymphocytes. Thank you. Anna Pron-Zwick/09-Jan-2013
CB6F1-TgN (RasH2) was the original nomenclature and this is what is used as the controlled terminology. The reason for the change is because CByB6F1-Tg(HRAS)2Jic is the nomenclature that Taconic uses and Taconic is the only supplier of rasH2 mice in the US. Taconic changed their nomenclature at some point between 05 andf 08 but I couldn't find exactly when.
According to the Clinical pathologist, the definition of the test is that it is measuring the Haemoglobin distribution width in the red blood cell, so it would be different than red blood cell distribution width. We considered mapping it to Hemoglobin, but this test is also being conducted for this study so it would be an error to have 2 data values reported for Hemoglobin.
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It appears in CDISC SEND Controlled Terminology, 2012-12-21, that the definitions are the same for C74756 CYTRPHOS Triple Phosphate Crystals and C74683 CYTYRO Tyrosine Crystals. The definition for both is "A measurement of the triple phosphate crystals present in a biological specimen." So it appears that the definition for Tyrosine Crystals needs to be updated. This same issue affects LBTEST as well.
It 'used to be' that the synonym for LBTESTCD was also the controlled term for LBTEST, or if there were two synonyms, the first one correlated to LBTEST. Now, however, when there are more than two synonyms for LBTESTCD, there is no correlation to LBTEST. It's literally twice the work and time to look up, first, the LBTESTCD, then the LBTEST.
Please see the attached list of terms for addition to the LB domains.
Please add the option Phase 1b Trial to the list as we have had a number of trials denoted as 1b recently
Please add the terms STEPS and BLOCKS to the Unit codelist; these terms are used in respiratory trials to capture the number of steps or blocks that a patient has walked
Please remove the synonym 'Pelvis' from the term PELVIC BONE - the term Pelvis is listed as a synonym and also as a submission value.
he definition text is not an exact match to the text on the questionnaire. Review requested by the QS Terminology team
Definitions do not match the questionnaire exactly. Review requested by the QS Terminology team.
Although Total Immunoglobulins (Ig) may not always be reported by the laboratory, it can be calculated by adding the three main classes of Ig: IgG, IgM, and IgA and would be reported in the SDTM LB domain as a derived lab test. Another possible term or synonym would be Total Ig.
On behalf of CDASH SAE team, they are submitting these new terms to be included within the SDTM UNIT codelist to be compliant with E2B SAE standard.
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Change to CNTCINVT, to be consistent with SCTEST/CD value. II
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This term is coming in from the Device terminology group. III
On behalf of CDASH SAE team, they are submitting a term to be included within the SDTM UNIT codelist to be compliant with E2B SAE standard.
Change NCI PT from EuroQOL Three Dimension Five Level Questionnaire to EuroQOL Five Dimension Three Level Questionnaire
ERMAX and ERLST: please add the following to the existing definition at the end of the definition. "...determined for the specimen type specified in PPSPEC". Update all definitions, including the normalizations.
PT = Pharmacogenomics Trial Characteristics This domain will store PGx Trial parameters that will store design paramerters use in performing the tests. This could include details on the array design.This will be a domain that SEND could use as well.
a. I would like tpo request that you sort your list by the Domain Code in alphabetical sequence.b. Some PGx domains seem to have been dropped. We also need some new ones.c. PG - change in the domain title - domain code stays the samed. New Domain codes: BE, BS, ES, PG, PF, PB, SB and VR
Parkinson;s Disease v1.0 Standards controlled terminology updates based on CDISC SRC approval of provisional PD User Guide on 20-Dec-12. I have sent and reviewed the CT spreadsheet with Bernice Yost that covers the either new terms updates for the following SDTM domains: FATEST, SCTEST, DIPARM, DOTEST, and DUTEST. In addition new terms are requested for the following code lists: METHOD and Relationship to Subject.
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This term is coming in from the Device terminology group. III
This request is from Barrie Nelson. II
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There are two method that reference x-rays - C38101 (XRAY) and C85830 (X-RAY FLUORESCENCE SPECTROMETRY). The first reference "XRay" and the second references "X-Ray". Please change C38101 from XRAY to X-RAY for consistency. Alternately, change C85830 from X-RAY FLUORESCENCE SPECTROMETRY to XRAY FLUORESCENCE SPECTROMETRY.
When the General Team discusses this request, we can have a Devices Team member available to answer questions.
When the General Team discusses this request, we can have a Devices Team member available to answer questions.
Please add the term ASPIRATION to the Method codelist. We use the term for the collection of samples for Oncology trials. NCI definition: Removal of fluid or tissue through a needle.
We will need labels as ADaM datasets increase in number. This rule could also apply to SDTM FA combination datasets AE (Adverse Events)and FA (Findings About Events or Interventions) would be FAAE (Findings About Adverse Events). This rule however breaks the 40 character limit for SAS labels and would be shortened.
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Alpha Hydroxybutyrate Dehydrogenase/α-HBDH III
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The present term erythrocytes distribution width should � �be changed to red cell distribution width for the following � �reasons:
� The abbreviation for this parameter is RDW. Thus, erythrocytes distribution width does not conform to the � �
abbreviation. Red cell distribution width conforms to the � �abbreviation, RDW.
� �Red cell distribution width is the terminology used �in modern human and veterinary hematology text books.o Feldman, BF, et. al., Schalm s Veterinary Hematology, �Lippincott Williams & Wilkins, Philadelphia, 2000, Chapter 1,
Clinical Automated Hematology Systems , pp. 3 11. � � �o Williams, WJ, et. al., Hematology, McGraw-Hill, New York, 1990, Chapter 2, Examination of the Blood , pp. 9 24.� � �
� �Red cell distribution width is the �description/definition of the measurement on modern hematology analyzers Advia 120 and 2120, Cell Dyn 3200, �etc.
� Internet search for erythrocyte distribution width � �returns primarily red cell distribution width � �Best regards, Glenn (Glenn S. Elliott, D.V.M., Ph.D.)
We need the mono/macro tests for the fluids such as thoracic, abdominal, pericardial.
Microscopic examination in Blood Cell Morphology in Whole Blood
Macrophages test is usually done in FLUID, BRONCHOALVEOLAR LAVAGE; FLUID, CEREBROSPINAL and FLUID, SYNOVIAL
Amplitude test is within the Whole Blood using aggregometry impedance method. Unit of Ohm if this helps.
PPTESTCD: AUCPBEODefinition: The area under the curve (AUC) from the observed concentration value at time zero to the first measured concentration value as a percentage of the area under the curve extrapolated to infinity. Applies only for intravascular bolus dosing.
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Surfactant protein D, also known as SFTPD or SP-D III
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test within FLUID, CEREBROSPINAL III
test within FLUID, CEREBROSPINAL III
test within FLUID, CEREBROSPINAL III
PPTEST: AUC %Back Extrapolation ObsDefinition: The area under the curve (AUC) from the observed concentration value at time zero to the first measured concentration value as a percentage of the area under the curve extrapolated to infinity. Applies only for intravascular bolus dosing.
Please consider adding a new LBTEST and LBTESTCD for the following term:"Mast Cell" absolute and percentage
Volume Wash is a manual or visual test done in the FLUID, BRONCHOALVEOLAR LAVAGE in mL
Here is a list of 21 - Lilly Methods codes that we would like to be included into CDISC terms.
Please consider adding a new LBTEST and LBTESTCD for the following term:"Bb Fragment of Factor B"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Butyl Cholinesterase"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Chymotrypsin"
Please consider adding a new LBTEST and LBTESTCD for the following term:"C-Reactive Protein High Sensitivity"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Corpuscular Hemoglobin Concentration Mean Gated"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Corpuscular Hemoglobin Content Gated"
microscopic examination in whole blood and in buffy coats III
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Platelet Rich Plasma (PRP) Aggregometry. Optical photometry III
Blood Cell Morphology - microscopic examination III
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Please consider adding a new LBTEST and LBTESTCD for the following term:"Pi Glutathione-S-Transferase" - GSTPI
Please consider adding a new LBTEST and LBTESTCD for the following term:"Content of Hemoglobin-Bound Oxygen"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Mean Amplitude"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Mean Curve Type"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Heinz Bodies" percent
Please consider adding a new LBTEST and LBTESTCD for the following term:"Glycosylated Hemoglobin" percent
Please consider adding a new LBTEST and LBTESTCD for the following term:"Immature Cells" percent
Please consider adding a new LBTEST and LBTESTCD for the following term:"Platelet Component Distribution Width"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Platelet Aggregation" Percent
Please consider adding a new LBTEST and LBTESTCD for the following term:"Platelet Activating Factor"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Thrombocyte Count"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Vacuolated Lymphocytes"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Troponin"
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Cell Morphology- Microscopic examination III
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Please consider adding a new LBTEST and LBTESTCD for the following term:"Total Ketone Bodies"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Thyroid Stimulating Hormone" - TSH
Please consider adding a new LBTEST and LBTESTCD for the following term:"Packed Cell Volume" - PCV
Please consider adding a new LBTEST and LBTESTCD for the following term:"Mean Platelet Dry Mass"
Please consider adding a new LBTEST and LBTESTCD for the following term:"MCV Reticulocytes"
Please consider adding a new LBTEST and LBTESTCD for the following term:"Iron Saturation" Percent
Please add semi-recumbent as a synonym to the current term of SEMI-FOWLERS
Reference: http://books.google.com/books?id=uCgWuJ7XG_gC&pg=PA242&lpg=PA242&dq=define+SEMI-FOWLERS+semi-recumbent&source=bl&ots=x_Skcf2ypw&sig=Se1Txhgz2iVhOvDVBxhWGIJf7ug&hl=en&sa=X&ei=NzgmUauGKqSO0QGHjoE4&ved=0CFkQ6AEwBg#v=onepage&q=define%20SEMI-FOWLERS%20semi-recumbent&f=falsePlease see this document: http://dtb.bmj.com/site/about/HBA1C_chart_Feb_10.pdf
Please add the term DECUBITUS to the Position codelist. � �We use this term for studies where they want to know what position the subject was in when the symptoms occurred. It s �not an assessment that has to be done with the patient in a specific condition, they need to know that the patient was lying down but not necessarily whether it was on their back, side or stomach.
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PK Team request. II
PK Team request. II
PK Team request. II
for dogs III
for ferret III
for Monkey III
for Monkey III
for Monkey III
for Monkeys III
for Monkeys III
for Monkeys III
Please add the term SUBJECT DISCONTINUED DUE TO �CAREGIVER WITHDRAWAL to the Completion/Reason for �Non-Completion codelist. We use this term for Alzheimer studies where the patient is no longer able to participate in the study without a caregiver s assistance. If the caregiver no �longer wants to help the patient participate in the study then the patient would not be able to participate. The caregiver would be someone without legal responsibility in other �words they do not have guardianship or make any legal decisions regarding care for the patient. They just provide daily assistance and care for the patient. To say WITHDRAWAL BY SUBJECT would not be correct nor would WITHDRAWAL BY PARENT/GUARDIAN.
for Monkeys III
for Monkeys III
for Monkeys III
for Monkeys III
for Monkeys III
for Monkeys III
for Monkeys III
for Monkeys III
for Rabbits III
for Marmosets III
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for Rabbit Juvenile III
for Rabbit Juvenile III
for Rabbit Juvenile III
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This term is for an ophthalmology trial III
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Term exists in the NCI-T: http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&version=13.01c&code=C12667
Term exists in the NCI-T: http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&version=13.01c&code=C12760
As we create extensible UNIT terms and attempt to follow CDISC convention, we are confused by the inconsistent use of "/sec" versus "/s" in the UNIT codelist. Why is there an inconsistency? Which convention should we follow to be CDISC-like?
Blood Urea Nitrogen - BUN - A measurement of the urea nitrogen in a blood specimen."Change to: Blood Urea Nitrogen - BUN - A measurement of the urea nitrogen in a biological specimen."
We test Urea Nitrogen in blood and within urine.
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for Rabbit Juvenile III
for Rabbit Juvenile III
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for Fish III
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for Mouse III
Please submit for discussion the direction taken for hair follicle tumorsIN SEND CT neoplasm list are:Carcinoma, Adnexal, malignantHair follicle neoplasm, benign or malignant or undetermined (that s 3 line items)�Pilomatrixoma, benign (which has a synonym of benign hair follicle neoplasm ..huh? what? I have 2 choices for one tumor?Trichoepithelioma, benignCombining Adnexal Carcinoma and Hair follicle neoplasms, SEND looks to be lumping together types of neoplasms with �the exception of Pilomatricoma and Trichoepithelioma. Why are there these 2 outliers (specific terminology names)2nd question if keep those 2 outliers�All other brethren of hair follicle tumors have been slighted. These brethren are (as per Veterinary Dermatopathology text)Tricofolliculoma a benign hair follicle tumor of dogs and �cats.Infundibular keratizing ancanthoma (aka intracutaneous cornifying epithelioma) a benign follicular neoplasm of dogs.Tricholemmoma, bulb type- neoplasm of the outer root sheath of the hair follicle.Tricholemmoma, isthmus-catagen type Neoplasm of the �isthmus segment of the hair follicleTrichoblastoma (basal cell tumor, benign) which should be a synonym for Neoplasm Basal Cell Benign Matrical carcinoma (syn malignant pilomatricoma)3) What is difference of Neoplasm, Basal Cell Malignant and Carcinoma, Basal Cell Malignant?4) Trichogenic adnexal tumor how is that differentiated �from the definition of pilomatrixoma?
Carol. J. Detrisac, DVM, PhD, DACVP
Present in NCI: http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C94908
for Rat III
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This request is from the Devices Terminology Team. III
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This request came from Cathy Bezek. She had missed the deadline for public comment on package 13.
Please add the term LYSATE to the Specimen Type codelist. This specimen type is used for the analysis of tests, such as cGMP (cyclic guanosine 3,5-monophosphate). The definition is: the mixture of substances formed by the lysis of cells.
Please add the term Cyclic Guanosine 3,5-Monophosphate to the Laboratory Test Name codelist with CGMP to the Laboratory Test Code codelist.Reference: http://www.piercenet.com/browse.cfm?fldID=ABEDD3AE-44EF-4469-BD2D-784F56A20892
Codelist Name CDISC Submission Value CDISC Synonym(s)Laboratory Test Code HIV1AB HIV-1 AntibodyLaboratory Test Code HIV12AB HIV-1/2 AntibodyLaboratory Test Code HIV2AB HIV-2 AntibodyLaboratory Test Code HIVVLD HIV Viral LoadLaboratory Test Code HIVIMONA HIV-1 Group M and O Nucleic AcidLaboratory Test Code HIVIOAB HIV-1 Group O AntibodyLaboratory Test Code HIVI24AG HIV-1 p24 AntigenLaboratory Test Code HIV2NUAC HIV-2 Nucleic Acid
In the first 2 examples above, the LBTESTCD submission value represents HIV-1 as a numeric 1 . But in examples 5-7 one � �is represented as I . Is this a mistake or a conscious ��decision? If the latter can it please be explained? It maybe that
I is used to differentiate the HIV-1 from the 24. But if this ��is a mistake, can they please be revised.I have a number of other p and gp antibodies to map and I m �not sure if I should represent them as HIV124AB or HIVI24AB.
All references of the Hamilton Anxiety Rating Scale (HAM-A) use HAM-A with the dash including in CDISC Definition. In addition, other instrument in Codelist Code C100129 which include dashes in the definition has the dash in the CDISC Submission Value (see ADAS-COG, BPRS-A etc.)
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Request from the PK Terminology Team. II
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In the reference materials provided to develop the Hamilton Anxiety Rating Scale (HAM-A) QS supplement, a section for Scoring is present (...with a total score range of 0-56, ...) yet no QSTESTCD / QSTEST values are currently present for the terminology.
Please add the tests Unspecified Cells (UNSPCELL) and Bronchial Epithelial Cells (EPIBRON). These cell types are being identified in a sputum microscopic analysis. The cell types identified are being counted and other cell types that are not specified are being captured under the Unspecified Cells which is used for the calculation of the percentage of each cell type.
During review of CV domain for posting to public review, the SRC found it confusing that 'LEFT' was in CVLAT rather than CVLOC, since other examples contained LEFT in CVLOC. Future used of CVLAT will be for side of body, not side of organ, therefore side of organ may need to be added to some LOC terms.
Please see the attached list of terms for addition to the LB domains. File sent on 2013-03-11
BONE, CALVARIUMBONE, CARPUSBONE, GROWTH PLATEGANGLION, CERVICOTHORACICJOINT, FEMOROTIBIALJOINT, SYNOVIAL TISSUELYMPH NODE, MANDIBULARTOOTH, PREMOLARJOINT, ELBOWJOINT, SCAPULOHUMERAL
Our team needs a domain to document the PGx design being used.
PERIANAL Per Dorland s Medical dictionary the definition � �is: Near or around the anus. Synonym = CIRCUMANALPERIURETHRAL Per Dorland s Medical dictionary the � �definition is: Occurring around the urethra.The current terms available in the LOC codelist of ANUS and URETHRA do not describe the area around the locations (i.e. the skin surrounding the locations) and therefore they are not sufficient.
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The industry standard for Complete Response with Incomplete Bone Marrow Recovery is CRi rather than Cri. The Complete Response values have both the C and R captialized.
Please add the term 'COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY as a synonym to the existing term Cri.Please refer to attached reference: http://bloodjournal.hematologylibrary.org/content/114/2/257/suppl/DC1
Hello,According to the term request website – multiple term request made be made by e-mail via an excel, delimited text file or similar file. Attached, please find our request for 9 terms to be added to the Procedure codelist.Please note – the instructions to submit a multiple term request gets lost at the end of the request spreadsheet. Can the statement be moved to the top and maybe provide a template that can be used as it is not known exactly what it needed within a multiple term request.
Please add a lab test for Alpha-1 Antichymotrypsin with a proposed test code of A1ANCHTR
C64387, mmol/L, The PK Terminology team would like to request that the definition be changed to: A unit of concentration (molarity unit) equal to one millimole of solute per one liter of solution.
These three synonyms are inconsistent with ALL other countries in the synonym list.
I was about to enter several requests to add new terms to the CDISC controlled terminology when I noticed the message in the footer suggesting that multiple requests be sent to this address in an Excel spreadsheet of CSV. I have attached both types; the contents are identical. All the requests are for new items in the SDTM LBTEST / LBTESTCD lists. If you have any questions, please do not hesitate to contact me. Thank you in advance for your assistance in this matter.
RECIST v1.1 indicates that Symptomatic Deterioration, defined as global deterioration of health status ... without objective evidence of disease progression, is a reason for stopping study therapy.
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Please add the term DEXA SCAN to the Method Codelist with the synonym 'Dual Energy X-Ray Absorptiometric Scan' and definition 'An imaging test that measures bone density (the amount of bone mineral contained in a certain volume of bone) by passing x-rays with two different energy levels through the bone. (NCI)'
Please consider adding the following terms: Hemolytic IndexIcterus IndexLipemia IndexTEG Coagulation IndexLipemiaHemolysisIcterus
Eosinophils Band Form A measurement of the banded eosinophils in a biological specimen.
Please consider adding the following LBTEST, LBTESTCD:Alpha-GST Excretion RateFractional Calcium ExcretionFractional Chloride ExcretionFractional Phosphorus ExcretionFractional Potassium ExcretionFractional Sodium ExcretionPi-GST Excretion RateTotal Oxalate ExcretionTotal Urine Albumin ExcretionTotal Urine Calcium ExcretionTotal Urine Chloride ExcretionTotal Urine Creatinine ExcretionTotal Urine Glucose ExcretionTotal Urine Magnesium ExcretionTotal Urine N-Acetyl-B-D-Glucosaminidase ExcretionTotal Urine Phosphorus ExcretionTotal Urine Potassium ExcretionTotal Urine Protein ExcretionTotal Urine Sodium Excretion
At Amgen, we inject our investigational product into the Abdomen and we would prefer to use this term over Abdominal Cavity (where Abdomen is listed as a synonym).
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Semi-Fowlers is a CDISC standardized term. According to resources within Amgen, this isn't as widely used/accepted as 'Semi-Recumbent'. We would like to propose adding 'Semi-Recumbent' to the Position code list. If that is not acceptable, please make 'Semi-Recumbent' a synonym to 'Semi-Fowlers'.
As there are so many, I would imagine there will be some questions. Please let me know if there are some. If you would rather get together in a meeting, I can make sure that my colleagues here will be in attendance as well to answer all questions.
A unit of the the number of biscuits given or observed.; Food consumption studies esp. for large animals will sometimes administer food in the form of biscuits (not frequent, but not uncommon), with measurements being of the number of biscuits present and the number of biscuits consumed. These numeric measurements can then be statistically analyzed.
Description VZ: Volume of distribution based on a single steady-state dosing interval. Computed as the Dose divided by the product of λz and AUC from 0 to τ.
VZF: Relative volume of distribution based on a single steady-state dosing interval. Computed as Vz divided by the fraction of dose absorbed.
Reference for description: Helen Moore, PhD Senior Scientific Consultant. Email [email protected]
Suggest to update Submission value to BODY WEIGHT with definition update since this term is really a measurement of body weight and nothing else.
Suggest to update Submission value to ORGAN WEIGHT with definition update since this term is really a measurement of body weight and nothing else.
While working on project in Europe as well as with NIH in the US, there have been several requests for CDISC to re-explore codelists for Education and Employment Status. Although differences will exist between US and Europe, it is worth trying to synchronize as FDA and EMA seek to work more closely together.
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Synonym list will be E-mailled to Chris Tolk III
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Based on the article "Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: The OABq. Quality of Life Research 563-574 (2002), the TEST and TESTCD for OABQ0119 should be updated from:
Current: OABQ01-Caused You Anxiety and WorrytoOABQ01-Caused You Anxiety or Worry
Please add the following test names, test codes and definitions to the Oncology Tumor Properties codelists:Slice Thickness (Test Code: SLTHKT)Definition: The most common distance between the slices in the sequence.Percent Change Sum Diameters From Bsln (Test Code: PCHSDBL)Definition: The sum of all non-nodal longest diameters and lymph node target short axes lesions at a specified time point and subtracting the sum of all non-nodal longest diameters and lymph node target short axes lesions from the baseline, then dividing the difference by the sum of all non-nodal longest diameters and lymph node target short axes lesions from the baseline.Percent Change Sum Diameters From Nadir (Test Code: PCHSDNAD)Definition: The sum of all non-nodal longest diameters and lymph node target short axes lesions at a specified time point and subtracting by the lowest value of all time points, then dividing the difference by the lowest value of all time points.
QS Term Rule violation. Our actual preference for QSCAT would be:"COMM1: Current Opioid Misuse Measure" but we realize that does not follow your rules.
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YOLK SACS TUMORS are not classified as ADENOMAS. II
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These 2 terms (and associated LBTEST labels) appear to be duplicated. The definitions are:APTTSTND: A relative measurement (ratio or percentage) of the subject's partial thromboplastin time to a standard or control partial thromboplastin time.APTTSPTT: A relative measurement (ratio or percentage) of the subject's activated partial thromboplastin time to a standard or control partial thromboplastin time.Can you please confirm and clarify which one to use? I need this fairly urgently for a study being actively mapped for submission now so your priority would be appreciated. Please note that this query was originally submitted on this form by Randall Austin on April 17 2012. Many thanks
I have a couple of Antibody tests for Measles (Rubeola):Measles (Rubeola) IgG antibody Measles (Rubeola) IgM antibody
I'm not sure whether the code should refer to Measles or Rubeola. Please advise on new terms.
Please add the term 'Sialyl SSEA-1 Antigen' to the Laboratory Test Name Codelist and SLXAG to the Laboratory Test Code Codelist with SLX as a syonynm for both terms. A reference for this term can be found at: http://www.ncbi.nlm.nih.gov/pubmed/1683194
Please add the term PLEURA to the Anatomical Location codelist. The definition from the NCI website is: A thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity. It protects and cushions the lungs. This tissue secretes a small amount of fluid that acts as a lubricant, allowing the lungs to move smoothly in the chest cavity while breathing.
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FDA is removing the following dosage forms from its SPL list: BEAD, IMPLANT, EXTENDED RELEASE; BLOCK; CEMENT; CIGARETTE; CONE; CORE, EXTENDED RELEASE; CULTURE; GENERATOR; GRAFT; GUM; GUM, RESIN; LINER, DENTAL; PACKING; SUTURE; UNASSIGNED; DIAPHRAGM. CDISC to decide what (if anything) it wants to do with this information. Options are to keep list as is or remove these to be consistent with SPL, though other parts of the agency and EMA may still be using and needing this for submission.
The FDA definitions were created by a group within FDA (Bill Hess) that has asked not to be attributed for the definitions.
BURSA OF FABRICIUS: An epithelial outgrowth of the cloaca in birds similar to the thymus in mammals. It atrophies within 6 months after birth and remains as a fibrous remnant in adult birds. It is composed of lymphoid tissue and prior to involution, is the site of B-lymphocyte maturation.
CROP: a saccular diverticulum of the esophagus just anterior to the entrance to the thorax. Present in all domestic birds. OR A crop (sometimes also called a croup or a craw, or ingluvies) is a thin-walled expanded portion of the alimentary tract used for the storage of food prior to digestion.
PROVENTRICULUS: A thin-walled, glandular stomach found in birds. It precedes the gizzard
SYRINX: The lower larynx in birds. The 'songbox' of a bird, situated at the point where the trachea divides into two branches, each of which connects with a lung. The vibration of a membrane within the syrinx produces sounds. The adjective from 'syrinx' is 'syringeal'Please consider promoting the unit term "Torr" to its own term rather than remaining as a synonym of "Millimeter of Mercury". Historically, one torr was intended to be the same as one "millimeter of mercury". However, subsequent redefinitions of the two units made them slightly different (by less than 0.000015%). Thank you. Anna Pron-Zwick/17-May-2013
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suggestion plus any other additional information: Please consider adding term "Lysate" as a specimen type. NCI Definition: The cellular debris and fluid produced by lysis of a cell. NCI Thesaurus Code: C62004. For example, lysate of red blood cells would be used as the sample for testing in hemoglobin electrophoresis. Thank you. Anna Pron-Zwick/17-May-2013
Ad defined in the STDM User Guide Version 3.1.2, the LBTESTCD of LBALL is permissible when all parameters are Not Done, however LBALL is not currently one of the choices for LBTESTCD
As defined in the SDTM User Guide Version 3.1.2, the EGTESTCD of EGALL is permissible when all parameters are Not Done, however EGALL is not currently one of the choices for EGTESTCD.
Please add the following responses (with synonyms) to the Tumor Response Result Codelist: sCR (stringent Complete Response), HI-E (Hematologic Improvement - Erythroid Response); HI-N (Hematologic Improvement - Neutrophil Response); HI-P (Hematologic Improvement - Platelet Response); mCR (Marrow Complete Response)This is Internationsl Working Group (IWG) response criteria used in our Oncology Trials for MDS (myelodysplastic syndromes)ADaM would like to reserve/define AX for non-compliant ADaM datasets
There are two terms missing from the published list, that are cited in the SDTM Implementation guide and CDISC SDTM Training: MULTIPLE (when someone selects more than one value) and OTHER (when other is selected and value is provided that does not correspond to the provided list). As this is a non-extensible list, these should offically be added.
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SEND would like to use this term in their Specimen codelist. However, the current CDISC definition is too human-centric so they suggested a change. Change Definition of Elbow Joint from A type of hinge joint located between the forearm and upper arm. (NCI) to: A joint involving the humerus, radius and ulna bones.
Please consider adding the virus terms in the file (eMailed separately) to the SDTM Microorganism code list. Thank you. Anna Pron-Zwick/29-May-2013
NCI Definition - Beneath the skin.Currently not covered in any of the existing anatomical location terms.
See the attached excel spreadsheet for the new ASTHMA TA terminology.
Copyrighted questionnaire from: 1968, 1989, 1990, 1991, 1999, 2000, 2010 Rudolf H. Moos. All Rights Reserved. Published by Mind Garden, Inc., www.mindgarden.com
SF-36v2 Health Survey 1992, 2000 Medical Outcomes Trust and Quality Metric Incorporated. All rights reserved. SF-36 is a registered trademark of Medical Outcomes Trust. (SF-36v2 Health Survey Acute, United States (English))
Need to add the following new QSTESTCD/QSTEST's that are listed on the CRF. Revised DAD QS Terminology spreadsheet was sent to B. Yost for review by QS Controlled Terminology Team. DAD0141 DAD01-Sub-Total Initiation Disability Assessment for Dementia - Sub-Total Initiation. DAD0142 DAD01-Sub-Total Planning & Organization Disability Assessment for Dementia - Sub-Total Planning & Organization. DAD0143 DAD01-Sub-Total Effective Performance Disability Assessment for Dementia - Sub-Total Effective Performance. DAD0144 DAD01-Total Score Disability Assessment for Dementia - Total Score. DAD0145 DAD01-Total % Disability Assessment for Dementia - Total %.
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Change C32509 to C12608 I
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This can be found at: http://www.dermatology.org.uk/quality/dlqi/quality-dlqi-questionnaire.html
I can provide test codes and test names for each of the questions if youwould like.
ADHD Rating Scale-IV Home Version(ADHD-RS); Reference: Guilford Press, Checklists, Norms, and Clinical Interpretation George J. DuPaul, Thomas J. Power, Arthur D. Anastopoulos, and Robert Reid 1998; CRF: http://www.healthchoiceaz.com/docs/providers/screeningtools/child%20adhd%20rating%20screener.pdfSheehan Disability Scale (SDS); Reference: Sheehan DV: The Anxiety Disease, Charles Scribner & Sons, New York, 1983; CRF Reference: http://www.cqaimh.org/pdf/tool_lof_sds.pdf
Please add Type 1 2nd degree AV Block as a synonym to the existing term of AV MOBITZ I
Please add Type 2 2nd degree AV Block as a synonym to the existing term of AV MOBITZ II
AGESPAN is currently not in 2013-04-12 version of SDTM controlled terminology but still in TSPARMCD codelist. Will the AGESPAN list be put back in next version?
Hello, I will email the file separately. I am submitting these requests on behalf of an AZ colleague (Angela Dymond). For questions about the requested PK terms, please contact Angela. EMail address for Angela Dymond is '[email protected]'. Thank you. Anna Pron-Zwick/13-Jun-2013Hello, I will email the file separately. I am submitting these requests on behalf of an AZ colleague (Angela Dymond). For questions about the requested PK terms, please contact Angela. EMail address for Angela Dymond is '[email protected]'. Thank you. Anna Pron-Zwick/13-Jun-2013
This is the specimen type sampled for a glucometer reading of blood sugar. It is commonly used in our diabetes studies.
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Rationale:Definitions: Interval by definition is a the period of time marked off by or between two events, instants, etc. or the distance between two points, objects, etc. Duration - is Continuance or persistence in time.Cardiac consultants standard reference is to PR,QT interval and QRS duration. QUESTION: with the EGTEST as it is at present, how are can we expect correct CRF completion when the SDTM terminology is not in line with standard Protocol detail, nor standard medical practice?
I will mail two back-up documents to the address above: The proposal for the IS and SR domains. The current draft of the Asthma TA User Guide, which includes information about Allergen Skin Testing.
Fix all definitions where the two letter domain code is in the definition to add the name of the domain in additions to the two letter code. Example the SB and TR. Check all definitions.
Combined study type - Absorption, Distribution, Metabolism, Excretion
Enterococcus thailandicus Atopobium rimae Peptoniphilus harei Odoribacter splanchnicus Alistipes shahii Megamonas funiformis Arthrobacter cumminsii Corynebacterium tuberculostearicum Clostridium bolteae Clostridium hathewayi Fusobacterium naviforme Tsukamurella pulmonis
Montgomery-Asberg Depression Rating Scale (MADRS); Montgomery SA, Asberg M: A new depression scale designed to be sensitive to change. British Journal of Psychiatry 134:382-389, 1979.; CRF www.cnsforum.com
For consistency it would make sense to update the definitions to start with something like 'The long name/short name of the….'
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For consistency it would make sense to update the definitions to start with something like 'The long name/short name of the….'
For consistency it would make sense to update the definitions to start with something like 'The long name/short name of the….'
The PK team will need to review and suggest edits to differentiate the two definitions.
The team will need to review and suggest edits to differentiate the two definitions.
TSPARMCD=STRATFCT is listed in appendix C3 and therefore should also be in the TSPARMCD and TSPARM controlled terminology.
To add PORTAL HILAR NODES. There are 'HILAR LYMPH NODES' or 'PORTAL LYMPH NODE' in C74456. PORTAL HILAR NODES is a different location as confirmed by one of our scientists: Portal nodes (external-liver general) and hilar nodes (typically within the lungs) are different concepts. PORTAL HILAR nodes is a specific lymph node site (within the liver near the confluence of vessels), and this is reasonable to consider separately. Please could this term be added to this codelist.OCCBLD - The definition is "A measurement of the blood in body products such as a stool sample, not detectable on gross examination." It is not clear whether this test also applies to a urine sample, where blood may be detectable on gross examination. If this does not apply to urine, what lab test code should be used for urine blood?
A general term is needed as specificity of exact nerve is not always captured. Per NCI a NERVE is: A bundle of fibers that receives and sends messages between the body and the brain. The messages are sent by chemical and electrical changes in the cells that make up the nerve.
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Fix double space in the CDISC submission value. I
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A general term is needed as specificity of an exact muscle is not always captured. The Definition of MUSCLE is: a body tissue consisting of long cells that contract when stimulated and produce motion.
PH is not a unit, it is a property. As we learned in first chemistry class, pH is dimensionless, i.e. it does not have a unit.
Remove this term or replace by "/min". The CDISC team mixes up property (beats of the heart) with the unit. Heart beat is to be measured as a frequency, so the unit must be e.g. "/min" or "/sec".
At primary school, I learned that "bar" is a unit of pressure. According to the unit codelist, "bar" is defined by: "A dosing measurement based on the bar unit". What is meant here? a) If it is meant to be the unit of pressure, please say so. b) if not, the definition is circular, i.e. the unit is defined by itself. That's not a definition c) if it is meant to be something like a "bar of chocolate", it can never be a unit. A unit (the word speaks for itself) should be the same everywhere in the world. Is a bar of chocolate the same quantity in Belgium as it is in the US as it is in Tokyo? I doubt so. Once again, the CDISC CT team is mixing up an "object" (the bar) with a "unit". The same applies for a good number of other CDISC units which are not units, like box, can, bottle, ... These are objects (parent class being "container"), not units. Semantically, taking these as units is completely nonsense.
All above TESTCD fields are not present currently in VS domain. File emailed separately.
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Within definition, should be '180 to 250' not '180 and 250'. I
Add period at end of sentence. I
Add period at end of sentence. I
I have reviewed this request with B. Yost and sent the QS Terminology team a revised UPDRS Terminology spreadsheet with these proposed additional Tests. Below is a summary of the EMAIL correspondence I have on research why these fields need to be added. Further details have been provides o the QS Terminology Team. It is not essential that an ADL in the presence of dyskinesias is obtained. The important score is ADL due to PD when the patient is at his worst (OFF) and when the pt is functioning at best (ON). For those interested in knowing the impact of dyskinesias and obtaining an ADL in the presence of dyskinesias, and ON score at worst dyskinesia can be scored on the bottom row. The OFF score in the dyskinesia row should be X d out. � I hope this helps.
Stanley Fahn, MD H. Houston Merritt Professor of Neurology/Columbia University Director, Movement Disorder Division Neurological Institute 710 West 168th Street New York, NY 10032 U.S.A. Phone 1-212-305-5277 Fax 1-212-305-3530 [email protected]://www.movement-disorders.org/
Hi, Steve, Your question is an interesting one. The S and E ADL scale provides the opportunity to rate % ADL (PD) best and �worst to capture ADLs during the on and off states. The �scoring sheet also provides opportunity to rate %ADL score �(dyskinesias) when the patient has advanced PD with motor �
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This questionnaire is in the public domain - I have sent the ver III
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Please add the following result terms to the list with suggested test code mapping: Abnormality EGTEST mapping UNUSUAL P AXIS SPRTARRY: Supraventricular Arrhythmias TRIFASICULAR BLOCK IVTIACD: Intraventricular and Intra-atrial Conduction INCREASED VOLTAGE CONSISTENT WITH LEFT VENTRICULAR HYPERTROPHY CHYPTENL: Chamber Hypertrophy or Enlargement T WAVE ALTERNANS STSTWUW: ST Segment, T wave, and U wave
STRATFCT "Stratification Factor" . Stratification factor is referred in the SDTM Implementation Guide but it is not included in the SDTM code list.
Sample Definition from literature: A malignant neoplasm of the peripheral nervous system composed of Schwann cells demonstrating invasion of adjacent tissues and potentially metastasis. Comment: The malignant version of a Schwannoma is a well established neoplastic finding in Veterinary and Laboratory animal pathology literature.
Sample definition from literature: A malignant intraneural or extraneural neoplasm arising from nerve tissues and neural sheaths, composed of perineurial-like fibroblasts and Schwann cells.A malignant intraneural or extraneural neoplasm arising from nerve tissues and neural sheaths, composed of perineurial-like fibroblasts and Schwann cells. Comment: The malignant version of a Neurofibrosarcoma is a well established neoplastic finding in Veterinary and Laboratory animal pathology literature.
Sample definition from literature: A benign polypoid neoplasm of a luminal or mucosal lining projecting into a luminal space or cavity. Comment: The endometrial stromal polyp, vaginal polyp and inflammatory polyp do not cover all of the instances of benign polyp in tissues of veterinary pathology
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Sample definition from literature: A malignant neuroendocrine neoplasm arising from enterochromaffin cells in the gastrointestinal tract and (less common) in the bronchiComment: Malignancy covers atypia and does not need to be in the tumor term. Aypical is not part of the diagnosis used for laboratory animal carcinoid tumors especially in the stomach of rats. This is the only malignant tumor on the C DISC SEND list that has atypical in the name of a malignant tumor (where is the typical one?)
from literature: A benign neuroendocrine neoplasm arising from enterochromaffin cells in the gastrointestinal tract and (less common) the bronchi.Comment: We do not use undetermined, and if the cells are well differentiated we need to be able to diagnose it as benign.
Sample definintion from literature: A malignant soft-tissue of the kidney neoplasm comprising two or more non-fibroblastic mesenchymal lines of differentiation that is infiltrative and traps tubules and glomeruli. Comment: Mesenchymal tumor is the established name of the unique benign or malignant tumor in rats. Sarcoma is too generic of a diagnosis and does not represent this specific tumor in kidney. The benign version is already in SEND we are just needing to add the malignant version.
Sample definition from literature: A benign embryonal neoplasm of the kidney.Comment: Should be able to diagnose the benign version of the nephroblastoma which is actually higher incidence than the malignant version.
Sample definition from literature: A malignant hair follicle neoplasm with trichoblastic differentiation.Comment: need the malignant version of this neoplasm.
Sample definition from literature: A malignant????? neoplasm composed of melanocytes.Comment: This benign tumor is needed for skin and eye in veterinary pathology.
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These tissues are often weighed for studies. III
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Revise the leukemias to take off the word "Acute". Tumors are not acute and chronic. This goes for acute monocytic, acute erythroid, and others. No change in definition because there is nothing about acute nature in the definition. Veterinary pathology does not use acute in neoplasm terminology.
Sample definition from literature: A benign neoplasm of the ovary, originating from granulosa cells.Comment: Relatively high use of the term at Merck for carcinogenicity studies. Fischer rat book defines both benign and malignant versions.
To keep consistency across all versions of the C-SSRS. The new submission values also provide more information of the original question in the questionnaire without going beyond the character limit.
Need to change CDISC Definition for an recurring question in 4 C-SSRS questionnaires. Please see attached file for details and change suggestions.
Please consider adding the following new term; BONE, CARPAL OR BONE, CARPUS
Please consider adding the following new term CHORDORMA, BENIGN CHOLANGOFIBROMA LEUKEMIA, LARGE GRANULAR LYMPHOCYTIC MELANOMA, BENIGN NEUROEPITHELIAL CARCINOMA, MALIGNANT NEUROMYOBLASTOMA, MALIGNANT PINEALOMA, BENIGN PLASMA CELL TUMOR, BENIGN SEMINOMA, BENIGN
This term was missed in first review, we only added the absolute in package 15 the total cells was overlooked. Please see original request 10-04-2013. MONOMACE - Monocytes/Macrocytes/Total Cells
This term was missed in first review, we only added the absolute in package 15 the total cells was overlooked. Please see original request 10-04-2013. MONOMACE - Monocytes/Macrocytes/Total Cells
NCI defines as "A fold of the peritoneum (the thin tissue that lines the abdomen) that surrounds the stomach and other organs in the abdomen."
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Not found in codelist or among new proposed terms from 2013-06-28. Informal definition: repeated scanning before and after contrast injection for a CT scan.
Our Clinical Data Standards group declined adopting this new codelist because the codelist name included the word "Response." Our company deploys the NYHA classification similar to ECOG or KPS, which codelist names do not include the word "Response". MPI utilizes all three performance/classification systems in the same fashion - the physician assigns the score/class. However with NYHA, there are two data collection methods - a physician assigned and a patient response. There are many published studies describing the disparities between these two types of results. It was not evident to us through the definition provided which context the CDISC term supports so we are maintaining our Millennium codelist "NYHA Classification Scale" (to represent objective assessment by the investigator; see www.heart.org about Class A, B, C, D based on objective assessment). One might argue that an Evaluator variable could be added to distinguish the source of the person providing the results but our team took the position that including the word "Response" in the codelist would represent that the original result was patient-reported. Could the CT team please clarify this codelist?
We require an anatomical location for reported abdominal pain. Until diagnostics are performed, the cause of the pain could be located either in the "Abdominal Cavity" (for which abdomen is currently listed as a synonym) or the "Abdominal Wall" (which is not now noted as a synonym). We feel that the more broad term is necessary to accurately represent the reported symptom.
The Study Directors have indicated that these definitions are confusing and that all of the designs based on their definition can be used interchangeably based on SD interpretation. If we want standardization the definitions should be clear on which to select by study type.
Dear Mr. Tolk, as requested in your e-mail of July 30th. I am entering here the request to add the codes QTcB and QTcF shortening.
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Tumorigenicity = the capability of causing tumors Oncogenicity = the capability of inducing tumor formation
Please add the terms HEMISPHERE, RIGHT and HEMISPHERE, LEFT to the anatomical location codelist. These two locations have distinct functions which would warrant distinguishing them as two separate locations rather than as one locatoin of HEMISPHERE and the laterality of Right versus Left. The left hemisphere is the cerebral hemisphere located on the left side of the corpus callosum. The left brain controls activities on the right side of the body, and in humans, usually controls speech and language functions. The thought processes of logic and calculation are generally associated with the left brain. The right hemisphere is the cerebral hemisphere located on the right side of the corpus callosum. The right brain controls activities on the left side of the body and, in humans, usually controls perception of spatial relationships and the ability to recognize common shapes and objects. The thought processes involved in creativity and imagination are generally associated with the right brain.
Please add the submission values of PRECUNEUS and STRIATUM to the Anatomical Location codelist. These terms are needed for PET Scan analysis in a clinical trial. Also, please add the term NEOSTRIATUM as a synonym to the submission value of STRIATUM.PRECUNEUS definition - A division of the medial surface of each cerebral hemisphere between the cuneus and the paracentral lobule; it lies above the subparietal sulcus and is bounded anteriorly by the marginal branch of the cingulate sulcus and posteriorly by the parietooccipital sulcus.
Please add the term DRIED BLOOD SPOT to the Specimen Type codelist. This is a specimen that is made from a whole blood specimen for analysis. This is a similiar concept of a processed specimen used for analysis as the existing term of PERIPHERAL MONONUCLEAR BLOOD CELL.
This request is made on behalf of the Asthma TA team. The specimen type would be used for the SRSPEC variable as the specimen type for an allergen skin test.
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A controlled term for in the SEND SPEC list is needed for Tympanic Bulla. This concept is shown in the nci metathesarus as a snomed preferred term. We have a client who does gross observations on this tissue, and we need an appropriate SPEC entry for it.
A controlled term for Ocular in the SEND list is needed for Ocular adnexa. This concept is shown in the nci metathesarus as a snomed synonym. We have a client who does gross and micro observations on this tissue, and we need an appropriate SPEC entry for it.
Use case: When a subject comes in for lumbar puncture for the purposes of CSF collection, the sample is collected via a spinal needle that must be inserted between the either the L2-L3 Intervertebral Space, or the L3-L4 Intervertebral Space. We need terminology to represent these intervertebral spaces in controlled terminology
We propose this addition to capture bi-dimensional measurements in target lymph node(s). PAXIS would be to SAXIS as LPERP is to LDIAM for non-nodal tumor measurements. Using existing terminology as a guide, the proposed definition is: The plane through a body or figure that is at a right angle to a given plane.
This a term request to add to SEND for ROUTE. There is not an appropriate term currently in the CDISC CT to map perivenous too. A synonym would be paravenous.
I am requesting that "Other" be removed as a CDISC term for ROUTE in SEND. The ROUTE is an extensible list so unpublished terms can be added which would be more useful for submission purposes. When "Other" is available, it is appears that it should be used versus adding a more descriptive user defined code.
I am requesting that "Other" be removed as a CDISC term for FREQ in SEND. The FREQ is an extensible list so unpublished terms can be added which would be more useful for submission purposes. When "Other" is available, it is appears that it should be used versus adding a more descriptive user defined code.
Please consider adding a field for viral strains in the SDTM Microorganism domain. Immediate intended use: to assist in the identification of various strains of the Influenza virus. This field has been defined in the Virology domain and could be extended to the Microorganism domain. Thank you. Anna Pron-Zwick/21-Aug-2013
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The SEND Repro team would like to add the term Large to its Result Findings codelist. CDISC has previously published this term in the SDTM-SIZE codelist and the Repro team reviewed the existing CDISC definition. They would like to edit the definition to include the fact that 'Large' is still in proportion. Suggested definition update: Of considerable or relatively great size, extent, or capacity, but normally proportioned. (NCI)
CDISC Submission Value, HEMOLIZED, for Code C70720 appears to be spelled incorrectly. Shouldn't this be HEMOLYZED? Note: Synonym = Hemolysis in Specimen
Some studies collect MRI as method when no additional detail is needed. Some studies need to know whether a contrast agent was used and we collected this as MRI WITH CONTRAST and MRI WITHOUT CONTRAST until recently. We have now adopted CDISC's CONTRAST ENHANCED MRI term. But there is still a need to collect and tabulate MRI WITHOUT CONTRAST to distinguish it from MRI (not otherwise specified). We ask that you consider adding this term to SDTM-METHOD.
Foot-Pound (ft.lb) is a unit of work equal to the work done by a force of one pound acting through a distance of one foot in the direction of the force. It is one of the units out of the Quantitative Muscle Testing Devices. File emailed separately.
The MCT system automatically collects and transmits ECG waveforms and heart rate wirelessly upon detection of pre-defined cardiovascular events to a remote monitoring center,without requiring direct patient interaction. The investigator will be notified by the remote MCT center about reportable events, additional recordable events may be captured by the MCT system but the investigator will not be notified.Needed for laboratory result for glycerol using glycerol tracer and microdialysis.
File emailed separately. This request is to add new terms to SDTM-LOC.
mmol/mmol unit is used for lab test USOCRR (Urine Sodium Creatinine Ratio).Similar test in SDTM is 'NACREAT'. We have typically always received this data in mmol/mmol. The nmol/mmol is not the standard SI unit typically used.
It was decided to add scoring items from the NPI Manual into QS terminology. Terms sent to [email protected]. in an attachment
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Vendors send ND to us when patients are recruited for a trial but imaging tests cannot find any evidence of disease. They also send NN and IR/SD so having these be included as official sysnonyms will help us automate the standardization of the terms.I would also like the CDISC Terminolgy team to confirm that ND or No Disease can be either specific to oncolgy or if it has applicability outside of oncology. There is always the pssoiblity that other therapeutic areas might start using the RS domain.
During the 2013 DIA, there was a session of Q&A regarding the CSR (Attached) where in Question 7 (Q7, Page 9) the question is raised on the difference between Protocol Deviation, Important Protocol Deviation and Protocol Violation. The answer in A7, of which part is displayed below, seems to encourage sponsors to replace the phrase protocol �violation in Annex IVa with protocol deviation .� � �In the CDISC/NCI Terminology, the word Protocol �Violation is used.� C48251 C66727 Completion/Reason for Non-Completion PROTOCOL VIOLATION An event or decision that stands in contrast to the guidelines set out by the protocol. (NCI)Excerpt from the attached document. ------------------------------------------------------------- Protocol violation and important protocol deviation are sometimes used interchangeably to refer to a significant departure from protocol requirements. The word violation can also have other meanings in a regulatory context. However, in Annex IVa of the ICH E3 guidance (Disposition of Patients), the term protocol violation was intended to mean only a change, divergence, or departure from the study requirements, whether by the subject or investigator, that resulted in a subject s withdrawal from study participation. (Whether such �subjects should be included in the study analysis is a separate question.) To avoid confusion over terminology, sponsors are encouraged to replace the phrase protocol violation in � �Annex IVa with protocol deviation, as shown in the � �example flowchart below. Sponsors can also choose to use another descriptor, provided that the information presented is generally consistent with the definition of protocol violation provided above. --------------------------------------------------------------- Because of this answer in the DIA, our Clinical team is reasoning to change the Protocol SOP with the wording
Protocol Deviation . � �So the question is:This concept is coded to the term 'Indication' in NCIt. Is the level of granularity correct or do we need to create a specific term (new c-code) for Trial Indication, as a child of Indication? The devices team wants to use Indication in a codelist and were uncomfortable with the idea of adding Trial Indication as a synonym.
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PK Terms for Package 15 - please see attached spreadsheet III
PK Terms for Package 16 - please see attached spreadsheet III
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Barbiturate overdose (primary method) and Exsanguination (secondary method) of termination used. With barbiturate overdose intravenous the barbiturate is the cause of death. Cutting blood vessels afterwards results in partial exsanguination as the heart is still beating, but the animal is already dead.
Add a QSTESTCD for the total score that is collected on the questionnaire. Likewise add a corresponding QSTEST value.
Add QSTESTCD = COWS101A to hold the numeric pulse value collected on the questionnaire. (The currectly-defined COWS101 QSTESTCD holds the score for the pulse.) This also requires the addition of a corresponding term to the QS-COWS TEST codelist. Propose "COWS1-Resting Pulse Rate beats/minute".
Please add a new EGTEST=Abnormality and EGTESTCD=ABNORMAL for the EG domain. These new terms are being requested to handle the "check that all apply" boxes on a CRF, where there are multiple configurations of how pre-specified abnormalities on an ECG are reported. The SDSLT suggested having a generic term to handle this.
The code C71043 (ECTOPIC SUPRAVENTRICULAR RHYTHM) from Codelist C71150 has disappeared between SDTM Terminology 2013-04-12 and 2013-06-28. I don't know where to find a change log on the NCI terminology page. Maybe this change was intentional and I missed something ?
SEND team suggests that work needs to be done on this term, invconjunction with developing the term of Ventriculus (which was pulled out of P15 for more review).
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Please consider the following LBTEST/CD: Sulfur Dioxide - SO2 III
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This is from the Virology IG. III
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Possible suggested update to definition as discussed by SEND team on 2013-09-20: A method of euthanasia in which barbiturate is administered intravenously/ (with or without prior anesthesia) to induce respiratory arrest. Following death, partial exsanguination may occur.
Please see attached document Oncology_Modify_Term_Request_Package16
Remove single quote from codelist short name in QS file. From Lex Jansen-having a small challenge with my programs because there is a single quote (') in a CDISC submission value for the codelist. From EM-Since the codelist short name has already been shortened, it is probably unneccessary to have the 's in there anyway.
This is being requested by the Virology Terminology Team. It was in the Virology IG.
Add ',BENIGN' to end of CDISC submission value: ADENOMA, ZYMBAL'S GLAND
CDISC LOC CT has the set of INTERPHALANGEAL JOINTs and PROXIMAL INTERPHALANGEAL JOINTs. These are named the same in the hand or foot, but the definitions in the CT are specific to the hand in one case and the foot in the other. Please change the definitions so they aren't hand/foot specific
The Submission Values and Synonyms do not follow the QS Naming Rules. I have sent a file to the above email address.
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A qualitative measurement of the cylindrical cells in a biological specimen.
Hemoglobin A1C/Total Hemoglobin: A relative measurement (ratio or percentage) of the glycosylated hemoglobin to total hemoglobin in a biological specimen.
Update definition of Hip Circumference and Waist Circumference in SDTM Terminology to provide clarity in how these measurements should be taken. "File emailed separately".
These 2 QSTESTCD / QSTEST values are currently missing from the MDS-UPDRS codelist.
Millimole Per Mole of Hemoglobin: A unit of substance concentration defined as the concentration of millimoles of solute per mole of hemoglobin.
New SCTESTCD and SCTEST to record dominant hand
I have created the CDISC CT spreadsheet for all necessary fields in the project. B. Yost is in the process of forming the CV Terminology Team and will start meetings on Tuesday's 1:)) EST to review these terminology needs; I have sent the spreadsheet to Bernice for these meetings;
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We need to try and adhere to the guiding principles for CDISC. 1. Keep the number of domains down whenever possible. This can be done by expanding the amount of information that can be collected and stored in a domain. 2. The description of the domain should adequately describe what can be stored without inadvertantly constraining the information that can be stored. 3. Try to keep the domain code names as stable as possible.
Please modify Sleep domain to extend to all sleep data that is collected in these type of studies.
Suggested defintion for SL domain"
"Subjective and objective (Polysomnography) measures of sleep disturbance and functionality".
Please add the unit mg/mL/min to the Unit codelist with the synonym Milligram per Milliter per Minute and the definition: A dose calculation unit expressed in milligram(s) per milliter(s) per period of time equal to sixty seconds. This unit is used with the drug Carboplatin in Oncology trials.
Protocol Milestone Codelist: two entries - Informed Consent Obtained and Randomized
IIIDear CDISC/ NCI,
I am providing a spread sheet in conduction with the online terminology request form to the above email. Here are a few comments that can also contribute to your team discussions. Both my fellow requestor and I are available for discussions if needed.
ECG Results: Lilly standardized how our vendors read ECGs in 1999 and we have several results that do not fit into the list provided by CDISC. As I understand it, this list is extensible so we would like to propose that CDISC add a few more terms to this listing. Attached you will find our recommendations. This request includes suggestions to add the following (and the document provides suggested definitions):
� Junctional Escape Complexes � Undetermined Rhythm � Other Rhythm � Asystole � Aberrant Conduction � Other Conduction � Low Voltage in Limb Leads � Other Morphology � Cannot Rule Out Possible Transmural Myocardial
Infarction � Evolving Acute Right Ventricular Myocardial Infarction � Age Undetermined Right Ventricular Myocardial
Infarction � Probable Hypercalcemia � Probably Hypocalcemia � PR Segment Depression
ECG Overread Method: I believe the Field Name (ECG Overread Method) and the Explanation (The ID of the lead(s) that was used for the interpretation of the cardiologist) are not appropriate. I believe what you are really looking for here is the Lead used for interval measurement based on the � �examples you have provided. In my opinion the interval measurement is usually conducted in a single lead or a median beat. However, the actual over read or interpretation must consider all leads and this provides qualitative assessments of the ECG and this cannot be accomplished by looking at the median beat. Can the Field Name and Explanation be changed to clarify what you expect in this field?
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Change the submission value to UNKNOWN for C17998. II
Change the submission value to UNKNOWN for C17998. II
Please consider adding the terms:Abdominal Fluid Other; Abdominal Fluid Other Percent; Azurophilic Granulations; BAL Others Percent; CSF %Others; Eosinophils Band; Eosinophils Band (n); Heterophils; Heterophils (SI); Heterophils Percent; High Absorption Retic Count; High Absorption Retic Count Percent; Iron Saturation Percent (Calc); Low Absorption Retic Count; Low Absorption Retic Count Percent; Med Absorption Retic Count; Med Absorption Retic Count Percent; Microfilaria; Oxalate (SI Calc) / Urine Creatinine (SI Calc) Ratio; Pericardial Fluid Other; Pericardial Fluid Other Percent; Pleural Fluid Other; Pleural Fluid Other Percent; Protozoa; Retic Distribution Width; Reticulocyte Corpuscular Hemoglobin Concentration Mean; Reticulocyte Corpuscular Hemoglobin Content; Synovial Fluid Other; Synovial Fluid Other Percent; Urine Aspartate Aminotransferase / Urine Creatinine Ratio; Urine Other; Urine Protozoa; Urine Uric Acid/Urine Creatinine Ratio
benign acinar-islet cell tumor; ASTROCYTOMA, BENIGN; GRANULOSA CELL TUMOR, BENIGN; OLIGODENDROGLIOMA, BENIGN; SCHWANNOMA, MALIGNANT; polyp, benign; EPENDYMOMA, BENIGN; chordoma, benign; Plasma cell tumor, malignant
Currently LBTEST C64807 Triacylglycerol Lipase is defined � �as A measurement of the pancreatic lipase in a biological �specimen . �Our LBTEST is for pancreatic lipase is in agreement with the definition for C64807, but the method does not pick up triaclyglycerol.
A new term should be added called Pancreatic lipase with � �the definition A measurement of the pancreatic lipase in a �biological specimen . �In addition, the term Triacylglycerol Lipase could remain � �but the definition should change to A measurement of the �triacylglycerol lipase in a biological specimen . �
Change the submission value to UNKNOWN for C17998. II
Change the submission value to UNKNOWN for C17998. II
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inconsistent form of term I
Please see attached spreadsheet. II
CDASH should match SDTM exactly. II
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dpm, disintegrations per minute, A unit of radioactive decay expressed in atoms of radioactive material that decay over a period of time equal to sixty seconds. (NCI)
pixel; The smallest resolvable rectangular area of an image, either on a screen or stored in memory.
Change CDISC Codelist name and Synonym to SEND Study Type. It is causing programmatic issues in SHARE due to the fact that the CDISC synonym is identical across both the SEND Study Type codelist and SDTM Study Type codelist.
C45908 The submission value of UN should be changed to Undifferentiated.
Trial Phase Codelist - NA should be NOT APPLICABLE C48660; No Yes Response Codelist - NA should be NOT APPLICABLE; Tumor Response Result Codelist - NA should be NOT APPLICABLE
There are two codelists with the same name of Study Type. The codelists names should be changed to SDTMIG Study Type and SEND Study Type.
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CMTRT is defined as, "Reported Name of Drug, Med, or Therapy". With the new Procedure Domain would the CMTRT definition change to just "Reported Name of Drug, or Medication" As a Therapy might be considered a procedure?
Thanks,
Lacey
The test result indicates whether the patient has an IL28B CC, CT, or TT genotype. The IL28B genotype test can be used to predict response to peg-IFN and RBV in HCV genotype 1 patients.
The test result indicates whether the patient has an IL28B CC, CT, or TT genotype. The IL28B genotype test can be used to predict response to peg-IFN and RBV in HCV genotype 1 patients.
Please see the attached spreadsheet to consider for Creation of New Terms to the Microorganism codelist (SDTM-MICROORG). The spreadsheet contains the requested submission value as well as synonym(s), where applicable. The terms are fungal organisms for addition to the Microorganism codelist.Needed to document the quanity of cells/kg in a CD34 graft.
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We need a new lab test code or a new specimen type code for the lab test "RBC Folate". There is a lab test for Folic acid - that is VITB9 with synonym "Folic Acid; Vitamin B9". There are separate tests available for folate in plasma and folate in RBCs. There is no specimen controlled terminology for RBCs or erythrocytes so if we used the same LBTESTCD the fact that the analyte is being measured in RBCs would not be clear. propose adding SPECTYPE "ERYTHROCYTES" with synonym "Erythrocytes; Red Blood Cells; RBCs". The other alternative is creating a new LBTESTCD specifically for RBC Folate. Folic acid can be measured in the liquid portion of blood (plasma). Folic acid can also be measured as the amount in the red blood cells. This test may be a better way than the plasma test to measure the amount of folic acid stored in the body.
This unit is used on the Teller Acuity cards for testing visual acuity. http://eiiwebassets.s3.amazonaws.com/s/sterooptical/pdf/other-manuals/TAC_II_manual.pdf
I was wondering if this requested term (cy/cm) was ever discussed as I never received a response. However, I also noticed that my requested term was incorrect based on other similar terms entered into the UNIT codelist - it should have been requested as: cycle/cm with a synonym as Cycle per Centimeter.
THANKS Colleen Bonjo
A general term is needed as specificity of exact nerve is not always captured. Per NCI a NERVE is: A bundle of fibers that receives and sends messages between the body and the brain. The messages are sent by chemical and electrical changes in the cells that make up the nerve.
A general term is needed as specificity of an exact muscle is not always captured. The Definition of MUSCLE is: a body tissue consisting of long cells that contract when stimulated and produce motion.
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To support an MTB biorepository. The form is asking for Mtb Isolate/Subculture, but I think it's unrealistic to think that the culture will always be genus/species ID'd and even if it is that information should probably be stored elsewhere. Thinking further along these lines, if the terms was simply ISOLATE that would probably be okay for our purposes. Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term Clinical Dementia Rating Test Code CDR0109 CDR01-Behavior Component and Personality Clinical Dementia Rating - Behavior Component and Personality Clinical Dementia Rating - Behavior Component and Personality Clinical Dementia Rating Test Code CDR0110 CDR01-Langiage Clinical Dementia Rating - Language Clinical Dementia Rating - Language
The approved copyright CDR CRF has 2 additional questions on page 2 that need to be added as new QS Terminology
Please add "Intentional right sided leads". This request comes from the ECG terminology team
Term code=C111131 (AVCOND) Term code=C111132 (AXISVOLT) Term code=C111155 (CHYPTENL) Term code=C111238 (IVTIACD) Term code=C111280 (MI) Term code=C111285 (PACEMAKR) Term code=C111307 (RHYNOS) Term code=C111312 (SNRARRY) Term code=C111320 (SPRARRY) Term code=C111321 (SPRTARRY) Term code=C111363 (STSTWUW) Term code=C111330 (VTARRY) Term code=C111331 (VTTARRY)
A measurement of the Cholera Toxin B Subunit IgG Antibody in serum after the administration of the recombinant cholera toxin b subunit vaccine.
Please add the term mV^2/Hz with the synonym millivolt^2/hertz. This unit is used in PSG sleep studies.
Please add the terms ELECTROENCEPHALOGRAPHY (with the synonym EEG) and POLYSOMNOGRAM (with the synonym PSG) to the method codelist. Both of these methods are used in sleep studies.
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File emailed separately. These terms come from the examples used in the Alzheimer’s Disease User Guide v2.Anatomical Location: PRECUNEUS, PONS VAROLII Unit: GAUGE Device-In-Use: Weighting, Interslice Spacing, Pixel Spacing X, Pixel Spacing Y, Inversion Time, Number of Slices, Acquisition Type, Decay Correction, Randoms Correction Morphology [NEW]: Volume, Thickness, Boundary Shift Integral Nervous System Physiology [NEW]: Standard Uptake Value Ratio Device Properties [NEW]: Size, Composition, Degree of Multiplexing, Coil Type, Detector Scintillation Crystals, Temperature Pharmacogenomics Findings [NEW]: Allele
For the studies which is not Randomized, can we have different term? For example, FAILURE TO MEET RANDOMIZATION/REGISTRATION CRITERIA
There's currently not a term avaiable for Percent Iron Saturation test.
All thrombocytes are nucleated by definition; they are nucleated platelets.
Please consider adding the following term: LBTEST: RBC Fragment (Other)LBTEST: RBCFRAGODefintion: Red Blood Fragment not typical of schistocyte
Please remove "MUSCLE, DISTAL" and "MUSCLE, PROXIMAL" as distal and proximal should go in --DIR
It is anticipated that any other terms currently on the VSTEST and VSTESTCD codelists will be submitted in the CV or RE domains and appropriate terms have been added to those test/code name codelists to cover.
Codelist Definition: The name given to the test code/name that analyzes a vital sign in nonclinical studies.; Codelist Long Name: SEND Vital Signs Test Name; Codelist Short Name: SVTEST/SVTESTCD
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Below is a communication from one of my colleagues working with immunophenotyping as endpoints in his tox-studies. He is trying to come up with some good rules for how we should be referencing the LBTESTs. I thought his rationale might be of interest to the CT team once they start looking into this:“Combinations of CD markers are not yet included in CDISC CT. We may just await a standard or we could proactively suggest a naming convention. In the data set provided by one source “/” has two meanings in the test names concerning CD markers. The use to yield relative counts (similar to already defined CDISC CT tests) makes the use as separator for CD markers undesirable. This is further underlined by looking at CDISC NCI code C82007 expressing the ratio between CD4 and CD8 cells as “CD4/CD8”. I Would personally prefer “CD3+CD4+CD25+/Lymphocytes” or even better “CD3+,CD4+,CD25+/Lymphocytes” before CD3/4/25/Lymphocytes. It is noted that in some instances the a cell population is defined by the absence of a marker, in which case the wish would be to note the exclusion by”-“ instead of “+”. This would not be possible in the absence of +/- markers. Further, considering LBTESTCD, 8 characters will inevitably at some occasions prove insufficient to hold all information regarding a combination of CD markers. Thus, the effort to keep meaning to LBTESTCD will likely fail at some point, and it might be worth to consider other alternatives. ”
Change codelist name and synonym to SDTM Domain Abbreviation. This change was agreed upon to be implemented with P16 terminology by the general team on 2013-11-22
Laboratory Test Code: MPXI Laboratory Test Name: Myeloperoxidase Index Defintion: The mean peroxidise activity index or staining intensity of the neutrophil population relative to the archetype
A unit of cell concentration expressed in cells per thousand RBCs.
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Peritoneal Fluid; Pericardial Fluid III
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This request is to add the following for SEND CT.LBTESTCD = TRAP5BLBTEST = Tartrate-Resistant Acid Phosphatase 5bDefinition = A measurement of Tartrate-Resistant Acid Phosphatase 5b in a biological specimen.Additional info: TRAP5b is the specific form of this enzyme used as bone marker so we have to use "5b".
Requesting the addition of SKIN OF THE HEAD, SKIN OF THE NECK and SKIN OF THE AXILLA for clinical trials capturing skin lesions. The locations of HEAD, NECK and AXILLA exist but they do not capture the fact that the lesions are on the skin for these regions of the body.Currently the terms SKIN OF THE TRUNK and SKIN OF THE LIP exist so requested using a similiar format.
Add to QSCAT codelist, C-SSRS Pediatric/Cognitively Impaired Lifetime/Recent
The term SOFT TISSUE originally existed in the Anatomical Location codelist but was moved to the Specimen Type codelist. Requesting the term SOFT TISSUE or a similiar term (such as TISSUE) be added back to the Anatomical Location codelist to capture the location of a soft tissue injury, soft tissue infection or soft tissue sarcoma.
Synonym: Millijoule per Square CentimeterDefinition: A unit of radiant exposure used in measuring the amount of energy incident upon an area of one square centimeter
We coded this to the wrong concept in NCIt. The term Coronavirus is a non-taxonomic term used to group the species within the 3 genera Gammacoronavirus, Alphacoronavirus, and Betacoronavirus. Since CDISC wanted the family level term, it is more correct to code this to Coronaviridae C113205. Also, not sure why CDISC chose CORONAVIRUS as the PT when CORONAVIRIDAE is more taxonomically correct for the family level term. Team needs to re-look at this.
Status Date of Submission
Open 1/3/2014 14:16 33105 Sunovion
Open 1/3/2014 14:17 33106 Sunovion
Open 1/3/2014 14:18 33107 Guy Genereux
Open 1/3/2014 14:19 33108 Steve Kopko CDISC
Open 1/3/2014 14:20 33109 Sunovion
Open 1/3/2014 14:20 33110 Sunovion
Open 1/3/2014 14:21 33111 Lex Jansen SAS
Open 1/10/2014 17:22 33117 Bayer
Open 1/10/2014 17:23 33118
Open 1/10/2014 17:23 33119
Open 1/17/2014 14:04 33121 Bernice Yost CDISC
Request Code
Submitter Name
Submitter Affiliation
Submitter E-mail
Request Type
Guy Genereux
Modify Existing Term
Guy Genereux
Modify Existing Term
Guy Genereux
Modify Existing Term
Create New Codelist
Guy Genereux
Modify Existing Term
Guy Genereux
Modify Existing Term
Modify Existing Term
Veronique Bourcier
Modify Existing Term
Audrey Walker
Create New Term
Audrey Walker
Create New Term
Create New Term
Open 1/17/2014 14:07 33123 MSC
Open 1/17/2014 14:08 33124 MSC
Open 1/17/2014 14:09 33125 MSC
Open 1/17/2014 14:10 33126 MSC
Open 1/17/2014 14:11 33127 MSC
Open 1/17/2014 14:11 33128 MSC
Open 1/17/2014 14:12 33129 MSC
Open 1/17/2014 14:13 33130 MSC
Open 1/17/2014 14:14 33131 MSC
Open 1/17/2014 14:15 33132 MSC
Open 1/17/2014 14:16 33133 MSC
Open 1/17/2014 14:16 33134 Emily Hartley
Open 1/17/2014 14:17 33135 Emily Hartley
Open 1/17/2014 19:36 33136 MSC
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Critical Path Institute
Create New Term
Critical Path Institute
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Open 1/24/2014 13:04 33142 MSC
Open 1/24/2014 13:05 33143 MSC
Open 1/24/2014 13:06 33144 MSC
Open 1/24/2014 13:06 33145 MSC
Open 1/24/2014 13:07 33146 MSC
Open 1/24/2014 13:08 33147 MSC
Open 1/24/2014 13:09 33148 Debbie Oneill Merck
Open 1/24/2014 17:28 33150 Debbie Oneill Merck
Open 1/24/2014 17:29 33151 Debbie Oneill Merck
Open 1/31/2014 19:05 33169 Debbie Oneill Merck
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Create New Term
Modify Existing Term
Create New Term
Create New Term
Open 1/31/2014 19:06 33170 Colleen Bonjo Merck
Open 1/31/2014 19:11 33171
Open 1/31/2014 19:12 33172 Debbie Oneill Merck
Open 1/31/2014 19:14 33173 MSC
Open 1/31/2014 19:15 33174 MSC
Open 1/31/2014 19:17 33175
Open 1/31/2014 19:18 33176 Bess LeRoy
Open 1/31/2014 19:20 33177
Create New Term
Audrey Walker
Charles River Laboratories
Create New Term
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Create New Term
Gary Cunningham
Teva Pharmaceuticals
Create New Term
Open 2/6/2014 13:23 33188 Charles River
Open 2/6/2014 13:24 33189 MSC
Open 2/6/2014 13:25 33190 Colleen Bonjo Merck
Open 2/6/2014 13:26 33191 Bess LeRoy C-Path
Open 2/6/2014 13:27 33192 Bess LeRoy C-Path
Open 2/6/2014 16:03 33193 MSC
Open 2/7/2014 17:57 33195 Carrie Neeley Covance Labs
Audrey Walker
Create New Term
Erin Muhlbradt
Create New Term
Create New Term
Create New Term
Create New Term
Erin Muhlbradt
Modify Existing Term
Create New Term
Open 2/7/2014 17:59 33196 GSK
Open 2/7/2014 18:00 33197 GSK
Open 2/7/2014 18:02 33198 MSC
Open 2/7/2014 18:03 33199 MSC
Open 2/7/2014 18:04 33200 Bess LeRoy C-Path
Open 2/14/2014 14:02 33207 Carrie Neeley Covance Labs
Open 2/14/2014 14:03 33208 Debbie Oneill Merck
Open 2/14/2014 14:04 33209
Open 2/14/2014 14:05 33210 Debbie Oneill Merck
Randall Austin
Modify Existing Term
Randall Austin
Create New Term
Erin Muhlbradt
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Create New Term
Create New Term
Create New Term
Jane Diefenbach
PharmaStat LLC
Create New Term
Create New Term
Open 2/14/2014 14:06 33211 Claire West GSK
Open 2/14/2014 14:07 33212 Otsuka
Open 2/14/2014 14:08 33213 MSC
Open 2/21/2014 17:16 33223 Biogen Idec
Open 2/21/2014 17:17 33224
Open 2/21/2014 17:18 33225
Open 2/28/2014 12:50 33231
Open 2/28/2014 12:52 33232 Merck
Open 2/28/2014 12:53 33233 Merck
Open 2/28/2014 12:54 33234 Nik Pemble Janssen
Open 3/7/2014 16:04 33236 Merck
Modify Existing Term
Kohji Mochinaga
Modify Existing Term
Erin Muhlbradt
Modify Existing Term
Scott Bahlavooni
Create New Term
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Debbie O'Neill
Create New Term
Debbie O'Neill
Create New Term
Modify Existing Term
Debbie O'Neill
Create New Term
Open 3/7/2014 16:06 33237 Merck & Co.
Open 3/7/2014 16:07 33238 Merck
Open 3/7/2014 16:08 33239 Merck
Open 3/7/2014 16:09 33240 Merck
Open 3/14/2014 12:10 33247 Carrie Neeley
Open 3/14/2014 12:11 33248 Carrie Neeley
Mary Jo Brucker
Create New Codelist
Debbie O'Neill
Modify Existing Term
Debbie O'Neill
Modify Existing Term
Debbie O'Neill
Create New Term
Covance Laboratories
Create New Term
Covance Laboratories
Create New Term
Open 3/14/2014 12:12 33249 Steve Kopko CDISC
Open 3/14/2014 12:14 33250 Steve Kopko CDISC
Open 3/14/2014 12:14 33251 Carrie Neeley
Open 3/14/2014 12:15 33252 Carrie Neeley
Open 3/14/2014 12:19 33253 Carrie Neeley
Open 3/14/2014 12:20 33254 Claire West GSK
Create New Codelist
Create New Codelist
Covance Laboratories
Create New Term
Covance Laboratories
Create New Term
Covance Laboratories
Create New Term
Create New Term
Open 3/14/2014 12:21 33255 Janet Siani Shire
Open 3/14/2014 12:22 33256 CSL Behring
Open 3/14/2014 12:23 33257 CSL Behring
Open 3/14/2014 12:23 33258 CSL Behring
Open 3/14/2014 12:24 33259 claire west gsk
Open 3/14/2014 12:25 33260 Bernice Yost CDISC
Open 3/14/2014 12:26 33261 Bernice Yost CDISC
Open 3/14/2014 12:26 33262 Bernice Yost CDISC
Modify Existing Term
Deborah Rittenhouse
Create New Term
Deborah Rittenhouse
Create New Term
Deborah Rittenhouse
Create New Term
Create New Term
Modify Existing Term
Modify Existing Term
Modify Existing Term
Open 3/14/2014 12:27 33263 Merck
Open 3/14/2014 12:28 33264
Open 3/14/2014 12:28 33265
Open 3/21/2014 11:39 33266 Pam Harvey CDISC
Open 3/21/2014 11:53 33267 Steve Kopko CDISC
Open 3/21/2014 11:54 33268 Amy Palmer CDISC
Open 3/21/2014 11:55 33269 EVS
Open 3/21/2014 11:55 33270 Merck
Open Accovion
Debbie O'Neill
Create New Term
Guy Genereux
Sunovion Pharmaceuticals
Modify Existing Term
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Create New Codelist
Create New Term
Create New Codelist
Erin Muhlbradt
Modify Existing Term
Debbie O'Neill
Create New Term
Friday, 28 Mar 2014 01:46 PM
CDISC-1076
Monika Kawohl
Create New Codelist
Open Merck
Open
Open Dana Booth CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open MSC
Open Pam Harvey CDISC
Open Biogen Idec Other
Open Bess LeRoy
Open Bernice Yost CDISC
Open Dana Booth CDISC
Friday, 28 Mar 2014 01:49 PM
CDISC-1077
Mary Jo Brucker
Modify Existing Term
Friday, 28 Mar 2014 01:50 PM
CDISC-1078
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 28 Mar 2014 01:51 PM
CDISC-1079
Create New Codelist
Friday, 28 Mar 2014 01:52 PM
CDISC-1080
Create New Term
Friday, 28 Mar 2014 01:53 PM
CDISC-1081
Create New Term
Friday, 28 Mar 2014 01:54 PM
CDISC-1082
Erin Muhlbradt
Modify Existing Term
Friday, 28 Mar 2014 02:04 PM
CDISC-1083
Create New Term
Friday, 4 Apr 2014 09:05 AM
CDISC-1084
Scott Bahlavooni
Friday, 4 Apr 2014 09:06 AM
CDISC-1085
Create New Term
Friday, 4 Apr 2014 09:07 AM
CDISC-1086
Modify Existing Term
Friday, 4 Apr 2014 09:08 AM
CDISC-1087
Create New Codelist
Open
Open Charles River
Open Merck
Open Claire West GSK
Open
Open Merck
Open
Open
Open
Friday, 4 Apr 2014 09:08 AM
CDISC-1088
Ellina Babouchkina
Quality Data Services, Inc.
Create New Codelist
Saturday, 12 Apr 2014 07:20 AM
CDISC-1089
Audrey Walker
Create New Term
Saturday, 12 Apr 2014 07:28 AM
CDISC-1090
Debbie O'Neill
Create New Term
Saturday, 12 Apr 2014 07:30 AM
CDISC-1091
Create New Term
Saturday, 12 Apr 2014 07:31 AM
CDISC-1092
Pamela Rinaldi
QT Studies TAUG team
Create New Term
Saturday, 12 Apr 2014 07:32 AM
CDISC-1093
Debbie O'Neill
Create New Term
Saturday, 12 Apr 2014 07:33 AM
CDISC-1094
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Saturday, 12 Apr 2014 07:34 AM
CDISC-1095
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Saturday, 12 Apr 2014 07:34 AM
CDISC-1096
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open Gloria Jones
Open
Open
Open
Open
Open
Open
Open
Open
Friday, 18 Apr 2014 08:38 AM
CDISC-1097
Janssen Pharmaceutical Companies of Johnson and Johnson
Create New Codelist
Friday, 18 Apr 2014 08:39 AM
CDISC-1098
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:39 AM
CDISC-1099
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:40 AM
CDISC-1100
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:40 AM
CDISC-1101
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:40 AM
CDISC-1102
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:40 AM
CDISC-1103
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:41 AM
CDISC-1104
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:41 AM
CDISC-1105
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open
Open
Open
Open
Open
Open
Open
Open
Open
Friday, 18 Apr 2014 08:42 AM
CDISC-1106
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:42 AM
CDISC-1107
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:42 AM
CDISC-1108
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:43 AM
CDISC-1109
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:43 AM
CDISC-1110
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:44 AM
CDISC-1111
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:45 AM
CDISC-1112
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:45 AM
CDISC-1113
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:45 AM
CDISC-1114
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open MSC
Open MSC
Open
Open
Open MSC
Open MSC
Open Carol Vaughn Sanofi
Friday, 18 Apr 2014 08:46 AM
CDISC-1115
Erin Muhlbradt (on behalf of the CDASH SAE team)
Create New Term
Friday, 18 Apr 2014 08:47 AM
CDISC-1116
Erin Muhlbradt
Create New Term
Friday, 18 Apr 2014 08:48 AM
CDISC-1117
Carsten Junge Pedersen
Ferring Pharmaceuticals A/S
Create New Term
Friday, 18 Apr 2014 08:49 AM
CDISC-1118
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 18 Apr 2014 08:50 AM
CDISC-1119
Erin Muhlbradt
Modify Existing Term
Friday, 18 Apr 2014 08:51 AM
CDISC-1120
Erin Muhlbradt (on behalf of Ron Fitzmartin, FDA)
Modify Existing Term
Friday, 18 Apr 2014 08:52 AM
CDISC-1121
Modify Existing Term
Open
Open Janet Siani Shire
Open Merck
Open Colleen Bonjo Merck
Open
Open
Friday, 18 Apr 2014 08:53 AM
CDISC-1122
Daniel DiPrimeo
BioMarin Pharmaceutical Inc.
Create New Term
Friday, 25 Apr 2014 10:24 AM
CDISC-1123
Create New Term
Friday, 25 Apr 2014 10:28 AM
CDISC-1124
Debbie O'Neill
Create New Term
Friday, 25 Apr 2014 10:34 AM
CDISC-1125
Create New Codelist
Friday, 25 Apr 2014 10:37 AM
CDISC-1126
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 25 Apr 2014 10:38 AM
CDISC-1127
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open
Open
Open
Open GSK
Open Janssen Other
Friday, 25 Apr 2014 10:39 AM
CDISC-1128
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 25 Apr 2014 10:40 AM
CDISC-1129
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 25 Apr 2014 10:46 AM
CDISC-1130
James Kramer
Johnson & Johnson / Janssen Research and Development
Create New Term
Friday, 25 Apr 2014 10:49 AM
CDISC-1131
Randall Austin
Modify Existing Term
Friday, 25 Apr 2014 10:51 AM
CDISC-1132
Nicholas Pemble
Open Merck
Open Merck
Open MSC
Open Colleen Bonjo Merck
Open Novartis
Open Novartis
Open Novartis
Friday, 2 May 2014 03:09 PM
CDISC-1133
Debbie O'Neill
Create New Term
Friday, 2 May 2014 03:12 PM
CDISC-1134
Debbie O'Neill
Create New Term
Friday, 2 May 2014 03:20 PM
CDISC-1135
Erin Muhlbradt
Modify Existing Term
Friday, 2 May 2014 03:21 PM
CDISC-1136
Modify Existing Term
Friday, 2 May 2014 03:23 PM
CDISC-1137
Theresa Hendershot
Create New Term
Friday, 2 May 2014 03:24 PM
CDISC-1138
Theresa Hendershot
Create New Term
Friday, 2 May 2014 03:25 PM
CDISC-1139
Theresa Hendershot
Create New Term
Open Novartis
Open Biogen Idec
Open Biogen Idec
Open MSC
Open MSC
Open MSC
Open MSC Other
Friday, 2 May 2014 03:27 PM
CDISC-1140
Theresa Hendershot
Create New Term
Friday, 2 May 2014 03:32 PM
CDISC-1141
Scott Bahlavooni
Create New Term
Friday, 2 May 2014 03:33 PM
CDISC-1142
Scott Bahlavooni
Create New Term
Friday, 2 May 2014 03:36 PM
CDISC-1143
Erin Muhlbradt
Modify Existing Term
Friday, 2 May 2014 03:37 PM
CDISC-1144
Erin Muhlbradt
Modify Existing Term
Friday, 2 May 2014 03:40 PM
CDISC-1145
Erin Muhlbradt
Create New Term
Friday, 2 May 2014 03:42 PM
CDISC-1146
Erin Muhlbradt
Open MSC
Open MSC
Open Charles River
Open Bernice Yost CDISC
Friday, 2 May 2014 03:44 PM
CDISC-1147
Erin Muhlbradt
Create New Term
Friday, 2 May 2014 03:45 PM
CDISC-1148
Erin Muhlbradt
Create New Term
Friday, 2 May 2014 03:48 PM
CDISC-1149
Audrey Walker
Create New Term
Thursday, 8 May 2014 09:12 PM
CDISC-1150
Modify Existing Term
Open Claire West GSK Other
Open MSC
Thursday, 8 May 2014 09:14 PM
CDISC-1151
Thursday, 8 May 2014 09:18 PM
CDISC-1152
Erin Muhlbradt (on behalf of SEND)
Create New Codelist
Open Carrie Neeley Covance
Open Carrie Neeley Covance
Thursday, 8 May 2014 09:21 PM
CDISC-1153
Create New Term
Thursday, 8 May 2014 09:22 PM
CDISC-1154
Create New Term
Open Amy Palmer CDISC
Open Amy Palmer CDISC
Open Bess LeRoy C-path
Open Bess LeRoy C-path
Open Bess LeRoy C-path
Open Novartis
Open Novartis
Open Novartis
Open Novartis
Open Carrie Neeley Covance
Open Dana Booth CDISC
Open Jordan Li MSC
Open Lou Florio Purdue Pharma
Open
Thursday, 8 May 2014 09:26 PM
CDISC-1155
Create New Term
Thursday, 8 May 2014 09:27 PM
CDISC-1156
Create New Term
Thursday, 8 May 2014 09:28 PM
CDISC-1157
Create New Term
Thursday, 8 May 2014 09:30 PM
CDISC-1158
Create New Term
Thursday, 8 May 2014 09:32 PM
CDISC-1159
Create New Term
Thursday, 8 May 2014 09:36 PM
CDISC-1160
Theresa Hendershot
Create New Term
Thursday, 8 May 2014 09:40 PM
CDISC-1161
Theresa Hendershot
Create New Term
Thursday, 8 May 2014 09:45 PM
CDISC-1162
Theresa Hendershot
Create New Term
Thursday, 8 May 2014 09:47 PM
CDISC-1163
Theresa Hendershot
Create New Term
Thursday, 8 May 2014 09:49 PM
CDISC-1164
Create New Term
Thursday, 8 May 2014 09:51 PM
CDISC-1165
Create New Term
Friday, 9 May 2014 12:40 PM
CDISC-1166
Modify Existing Term
Friday, 16 May 2014 03:49 PM
CDISC-1167
Create New Term
Friday, 16 May 2014 03:59 PM
CDISC-1168
Takahiro Takeuchi (竹内崇裕)
Otsuka Pharmaceutical Co., Ltd.
Create New Term
Open Carrie Neeley Covance
Open CDISC
Open
Open Colleen Bonjo Merck
Open Charles River
Open Merck
Open Pam Harvey CDISC
Friday, 16 May 2014 04:01 PM
CDISC-1169
Create New Term
Friday, 16 May 2014 04:05 PM
CDISC-1170
Robert Dempsey
Modify Existing Term
Friday, 16 May 2014 04:06 PM
CDISC-1171
Lorraine Spencer
Takeda Pharmaceuticals
Create New Term
Friday, 16 May 2014 04:09 PM
CDISC-1172
Modify Existing Term
Friday, 16 May 2014 04:11 PM
CDISC-1173
Audrey Walker
Create New Term
Friday, 16 May 2014 04:14 PM
CDISC-1174
Debbie O'Neill
Modify Existing Term
Friday, 16 May 2014 04:16 PM
CDISC-1175
Create New Term
Open Merck
Open Carrie Neeley Covance
Open Charles River
Friday, 16 May 2014 04:18 PM
CDISC-1176
Debbie O'Neill
Create New Term
Friday, 23 May 2014 02:16 PM
CDISC-1177
Create New Term
Friday, 23 May 2014 02:18 PM
CDISC-1178
Audrey Walker
Create New Term
Open Amy Moore
Open Colleen Bonjo Merck
Open Bernice Yost CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Friday, 23 May 2014 02:23 PM
CDISC-1179
Create New Term
Friday, 23 May 2014 02:40 PM
CDISC-1180
Create New Codelist
Friday, 23 May 2014 02:43 PM
CDISC-1181
Create New Term
Friday, 23 May 2014 02:46 PM
CDISC-1182
Robert Dempsey
Create New Term
Friday, 23 May 2014 03:39 PM
CDISC-1183
Robert Dempsey
Create New Term
Friday, 23 May 2014 03:40 PM
CDISC-1184
Robert Dempsey
Create New Term
Friday, 23 May 2014 03:42 PM
CDISC-1185
Robert Dempsey
Create New Term
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Friday, 23 May 2014 03:44 PM
CDISC-1186
Robert Dempsey
Create New Term
Friday, 23 May 2014 03:45 PM
CDISC-1187
Robert Dempsey
Create New Term
Friday, 23 May 2014 03:46 PM
CDISC-1188
Robert Dempsey
Create New Term
Friday, 23 May 2014 03:48 PM
CDISC-1189
Robert Dempsey
Create New Term
Friday, 23 May 2014 03:52 PM
CDISC-1190
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:01 PM
CDISC-1191
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:03 PM
CDISC-1192
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:05 PM
CDISC-1193
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:06 PM
CDISC-1194
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:07 PM
CDISC-1195
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:09 PM
CDISC-1196
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:10 PM
CDISC-1197
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:11 PM
CDISC-1198
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:12 PM
CDISC-1199
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:14 PM
CDISC-1200
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:15 PM
CDISC-1201
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:17 PM
CDISC-1202
Robert Dempsey
Create New Term
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open CDISC
Open Nik Pemble Janssen
Friday, 23 May 2014 05:18 PM
CDISC-1203
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:19 PM
CDISC-1204
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:20 PM
CDISC-1205
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:21 PM
CDISC-1206
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:22 PM
CDISC-1207
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:23 PM
CDISC-1208
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:24 PM
CDISC-1209
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:25 PM
CDISC-1210
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:26 PM
CDISC-1211
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:29 PM
CDISC-1212
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:29 PM
CDISC-1213
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:31 PM
CDISC-1214
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:32 PM
CDISC-1215
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:33 PM
CDISC-1216
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:35 PM
CDISC-1217
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:36 PM
CDISC-1218
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:37 PM
CDISC-1219
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:38 PM
CDISC-1220
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:39 PM
CDISC-1221
Robert Dempsey
Create New Term
Friday, 23 May 2014 05:40 PM
CDISC-1222
Modify Existing Term
Open Nik Pemble Janssen
Open Pfizer
Open Nik Pemble Janssen
Open Charles River
Open Charles River
Open Charles River
Open Bernice Yost CDISC
Open Colleen Bonjo Merck
Open Colleen Bonjo Merck
Open Colleen Bonjo Merck
Open Colleen Bonjo Merck
Friday, 23 May 2014 05:42 PM
CDISC-1223
Create New Term
Thursday, 29 May 2014 07:00 PM
CDISC-1224
Roberta Rosenberg
Create New Term
Thursday, 29 May 2014 07:03 PM
CDISC-1225
Create New Term
Thursday, 29 May 2014 07:05 PM
CDISC-1226
Audrey Walker
Create New Term
Thursday, 29 May 2014 07:07 PM
CDISC-1227
Audrey Walker
Create New Term
Thursday, 29 May 2014 07:08 PM
CDISC-1228
Audrey Walker
Create New Term
Thursday, 29 May 2014 07:11 PM
CDISC-1229
Modify Existing Term
Thursday, 29 May 2014 07:13 PM
CDISC-1230
Create New Codelist
Thursday, 29 May 2014 07:36 PM
CDISC-1231
Create New Codelist
Friday, 6 Jun 2014 11:25 AM
CDISC-1232
Create New Codelist
Friday, 6 Jun 2014 11:27 AM
CDISC-1233
Create New Codelist
Open Dana Booth CDISC
Open Bernice Yost CDISC
Open Colleen Bonjo Merck
Open Colleen Bonjo Merck
Open Colleen Bonjo Merck
Open Colleen Bonjo Merck
Open Colleen Bonjo Merck
Open CDISC
Open CDISC
Open Colleen Bonjo Merck
Open Bernice Yost CDISC
Friday, 6 Jun 2014 11:30 AM
CDISC-1234
Create New Codelist
Friday, 6 Jun 2014 11:31 AM
CDISC-1235
Modify Existing Term
Friday, 6 Jun 2014 11:32 AM
CDISC-1236
Create New Codelist
Friday, 6 Jun 2014 11:36 AM
CDISC-1237
Create New Codelist
Friday, 6 Jun 2014 11:36 AM
CDISC-1238
Create New Codelist
Friday, 6 Jun 2014 11:38 AM
CDISC-1239
Create New Codelist
Friday, 6 Jun 2014 11:39 AM
CDISC-1240
Create New Codelist
Friday, 13 Jun 2014 11:14 AM
CDISC-1241
Robert Dempsey (for Phil Pochon)
Modify Existing Term
Friday, 13 Jun 2014 11:22 AM
CDISC-1242
Robert Dempsey (for Phil Pochon)
Create New Term
Friday, 13 Jun 2014 11:26 AM
CDISC-1243
Create New Term
Friday, 13 Jun 2014 11:32 AM
CDISC-1244
Modify Existing Term
Open Janet Siani Shire
Open Merck
Open Jordan Li NCI EVS
Open Janssen
Open Phil Pochon Covance
Open Phil Pochon Covance
Open Phil Pochon Covance
Open Charles River
Open Virginie Soete
Open Virginie Soete
Friday, 13 Jun 2014 11:50 AM
CDISC-1245
Modify Existing Term
Friday, 13 Jun 2014 11:52 AM
CDISC-1246
Debbie O'Neill
Modify Existing Term
Thursday, 19 Jun 2014 05:05 PM
CDISC-1247
Modify Existing Term
Friday, 20 Jun 2014 11:06 AM
CDISC-1248
Ward Puttemans
Modify Existing Term
Friday, 20 Jun 2014 11:09 AM
CDISC-1249
Create New Term
Friday, 20 Jun 2014 11:12 AM
CDISC-1250
Modify Existing Term
Friday, 20 Jun 2014 11:13 AM
CDISC-1251
Create New Term
Friday, 20 Jun 2014 11:15 AM
CDISC-1252
Audrey Walker
Create New Term
Friday, 20 Jun 2014 11:19 AM
CDISC-1253
Business&Decision Life Sciences
Create New Term
Friday, 20 Jun 2014 11:20 AM
CDISC-1254
Business&Decision Life Sciences
Create New Term
Open CDISC
Open CDISC
Open Richard Addy
Open Merck
Friday, 20 Jun 2014 11:22 AM
CDISC-1255
Pam Harvey (on behalf of Stephanie Caruso)
Create New Term
Friday, 20 Jun 2014 11:23 AM
CDISC-1256
Pam Harvey (on behalf of Stephanie Caruso)
Create New Codelist
Friday, 27 Jun 2014 12:11 PM
CDISC-1257
Rho: Full-Service Contract Research Organization
Create New Term
Friday, 27 Jun 2014 12:15 PM
CDISC-1258
Debbie O'Neill
Modify Existing Term
Open Carrie Neeley Covance
Open Other
Open Bess LeRoy C-path
Open Bernice Yost CDISC
Open Charles River
Friday, 27 Jun 2014 12:16 PM
CDISC-1259
Create New Term
Friday, 27 Jun 2014 12:18 PM
CDISC-1260
Rajinder Randhawa
GlaxoSmithKline
Friday, 27 Jun 2014 12:21 PM
CDISC-1261
Create New Term
Friday, 27 Jun 2014 12:24 PM
CDISC-1262
Modify Existing Term
Friday, 27 Jun 2014 12:25 PM
CDISC-1263
Audrey Walker
Create New Term
Open Gitte Frausing
Open Dana Booth CDISC Other
Open Bernice Yost CDISC
Friday, 27 Jun 2014 12:26 PM
CDISC-1264
Novo Nordisk A/S
Create New Term
Friday, 27 Jun 2014 12:27 PM
CDISC-1265
Friday, 27 Jun 2014 12:29 PM
CDISC-1266
Modify Existing Term
Open NCI EVS
Open Claire West GSK
Open CDISC
Open CDISC
Open Merck
Open CDISC
Open CDISC
Open Gitte Frausing Novo Nordisk
Open Charles River
Friday, 27 Jun 2014 12:31 PM
CDISC-1267
Jordan Li (on behalf of SEND-FXLOC team)
Modify Existing Term
Thursday, 3 Jul 2014 05:24 PM
CDISC-1268
Modify Existing Term
Thursday, 3 Jul 2014 05:28 PM
CDISC-1269
Robert Dempsey
Modify Existing Term
Thursday, 3 Jul 2014 05:30 PM
CDISC-1270
Robert Dempsey
Modify Existing Term
Thursday, 3 Jul 2014 05:32 PM
CDISC-1271
Debbie O'Neill
Create New Term
Friday, 11 Jul 2014 11:50 AM
CDISC-1272
Robert Dempsey
Modify Existing Term
Friday, 11 Jul 2014 11:50 AM
CDISC-1273
Robert Dempsey
Modify Existing Term
Friday, 11 Jul 2014 11:53 AM
CDISC-1274
Create New Term
Friday, 11 Jul 2014 11:54 AM
CDISC-1275
Audrey Walker
Create New Term
Open Merck
Open CDISC
Open Bernice Yost CDISC Other
Open Bernice Yost CDISC Other
Open Janet Siani Shire
Open Janet Siani Shire
Friday, 11 Jul 2014 11:56 AM
CDISC-1276
Debbie O'Neill
Create New Term
Friday, 18 Jul 2014 09:39 AM
CDISC-1277
Robert Dempsey
Modify Existing Term
Friday, 18 Jul 2014 09:40 AM
CDISC-1278
Friday, 18 Jul 2014 09:41 AM
CDISC-1279
Friday, 18 Jul 2014 09:43 AM
CDISC-1280
Modify Existing Term
Friday, 18 Jul 2014 09:45 AM
CDISC-1281
Modify Existing Term
Open Biogen Idec
Open Biogen Idec
Open
Friday, 18 Jul 2014 09:49 AM
CDISC-1282
Scott Bahlavooni
Create New Term
Friday, 18 Jul 2014 10:04 AM
CDISC-1283
Scott Bahlavooni
Create New Term
Friday, 18 Jul 2014 10:24 AM
CDISC-1284
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open
Open Anita Umesh Illumina None
Open biogen idec
Open AstraZeneca
Open Colleen Bonjo Merck
Open Colleen Bonjo Merck
Open NCI EVS
Open NCI EVS
Friday, 18 Jul 2014 10:32 AM
CDISC-1285
Mark Gummel
Theorem Clinical Research
Modify Existing Term
Friday, 18 Jul 2014 10:33 AM
CDISC-1286
Friday, 25 Jul 2014 12:09 PM
CDISC-1287
Sarah McLaughlin
Friday, 25 Jul 2014 12:11 PM
CDISC-1288
Anna Pron-Zwick
Create New Term
Friday, 25 Jul 2014 12:14 PM
CDISC-1289
Create New Term
Friday, 25 Jul 2014 12:17 PM
CDISC-1290
Create New Term
Friday, 25 Jul 2014 12:20 PM
CDISC-1291
Erin Muhlbradt (on behalf of SEND repro team)
Modify Existing Term
Friday, 25 Jul 2014 12:25 PM
CDISC-1292
Erin Muhlbradt (on behalf of SEND repro team)
Modify Existing Term
Open NCI EVS
Open NCI EVS
Open Jon Neville C-Path
Open Carrie Neeley Covance
Open AstraZeneca
Open Lily
Open Colleen Bonjo Merck
Friday, 25 Jul 2014 12:27 PM
CDISC-1293
Erin Muhlbradt (on behalf of SEND repro team)
Modify Existing Term
Friday, 25 Jul 2014 12:31 PM
CDISC-1294
Erin Muhlbradt (on behalf of SEND repro team)
Modify Existing Term
Friday, 25 Jul 2014 12:58 PM
CDISC-1295
Friday, 25 Jul 2014 01:23 PM
CDISC-1296
Create New Term
Friday, 25 Jul 2014 02:02 PM
CDISC-1297
Anna Pron-Zwick
Create New Term
Friday, 25 Jul 2014 02:04 PM
CDISC-1298
Lacey Wallace
Create New Term
Friday, 25 Jul 2014 02:05 PM
CDISC-1299
Create New Term
Open Sanofi
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Friday, 25 Jul 2014 02:07 PM
CDISC-1300
Mihaela Simion
Create New Term
Friday, 1 Aug 2014 01:29 PM
CDISC-1301
Modify Existing Term
Friday, 1 Aug 2014 01:29 PM
CDISC-1302
Modify Existing Term
Friday, 1 Aug 2014 01:30 PM
CDISC-1303
Modify Existing Term
Friday, 1 Aug 2014 01:31 PM
CDISC-1304
Modify Existing Term
Friday, 1 Aug 2014 01:32 PM
CDISC-1305
Modify Existing Term
Friday, 1 Aug 2014 01:34 PM
CDISC-1306
Modify Existing Term
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open NCI EVS
Open NCI EVS
Friday, 1 Aug 2014 01:35 PM
CDISC-1307
Modify Existing Term
Friday, 1 Aug 2014 01:36 PM
CDISC-1308
Modify Existing Term
Friday, 1 Aug 2014 01:37 PM
CDISC-1309
Modify Existing Term
Friday, 1 Aug 2014 01:39 PM
CDISC-1310
Erin Muhlbradt (on behalf of SEND REPRO team)
Modify Existing Term
Friday, 1 Aug 2014 01:41 PM
CDISC-1311
Erin Muhlbradt (on behalf of SEND REPRO team)
Modify Existing Term
Open NCI EVS
Open NCI EVS
Open Merck
Open Merck
Open Merck
Open AstraZeneca
Friday, 1 Aug 2014 01:47 PM
CDISC-1312
Erin Muhlbradt
Modify Existing Term
Friday, 1 Aug 2014 01:48 PM
CDISC-1313
Erin Muhlbradt
Modify Existing Term
Friday, 1 Aug 2014 01:51 PM
CDISC-1314
Debbie O'Neill
Create New Term
Friday, 1 Aug 2014 01:52 PM
CDISC-1315
Debbie O'Neill
Create New Term
Friday, 1 Aug 2014 01:54 PM
CDISC-1316
Debbie O'Neill
Create New Term
Friday, 1 Aug 2014 01:55 PM
CDISC-1317
Anna Pron-Zwick
Create New Term
Open Pam Harvey CDISC
Open Pfizer
Open
Open Merck
Open Claire West GSK
Open Nik Pemble Janssen Other
Friday, 1 Aug 2014 01:57 PM
CDISC-1318
Create New Term
Friday, 1 Aug 2014 01:59 PM
CDISC-1319
Christopher Eley
Create New Term
Friday, 1 Aug 2014 02:01 PM
CDISC-1320
Marcelina Hungria
DIcore Group, LLC
Create New Codelist
Thursday, 7 Aug 2014 03:47 PM
CDISC-1321
Debbie O'Neill
Create New Term
Thursday, 7 Aug 2014 03:50 PM
CDISC-1322
Create New Term
Thursday, 7 Aug 2014 03:51 PM
CDISC-1323
Open Alla Yelina AbbVie
Open
Open
Open
Open
Open
Open
Thursday, 7 Aug 2014 03:53 PM
CDISC-1324
Create New Term
Friday, 8 Aug 2014 03:15 PM
CDISC-1325
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:15 PM
CDISC-1326
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:17 PM
CDISC-1327
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:20 PM
CDISC-1328
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:21 PM
CDISC-1329
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:22 PM
CDISC-1330
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open
Open
Open
Open
Open
Open
Open
Open
Friday, 8 Aug 2014 03:23 PM
CDISC-1331
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:23 PM
CDISC-1332
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:25 PM
CDISC-1333
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:26 PM
CDISC-1334
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:26 PM
CDISC-1335
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:32 PM
CDISC-1336
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:34 PM
CDISC-1337
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:36 PM
CDISC-1338
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open
Open
Open
Open
Open
Open
Open
Open
Friday, 8 Aug 2014 03:37 PM
CDISC-1339
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:38 PM
CDISC-1340
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:39 PM
CDISC-1341
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:48 PM
CDISC-1342
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:50 PM
CDISC-1343
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 8 Aug 2014 03:51 PM
CDISC-1344
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 15 Aug 2014 12:17 PM
CDISC-1345
Lorraine Spencer
Takeda Pahrmaceuticals
Create New Term
Friday, 15 Aug 2014 12:21 PM
CDISC-1346
Jane Diefenbach
NIH/NIAID/DAIDS
Create New Term
Open
Open NCI EVS
Open NCI EVS
Friday, 15 Aug 2014 12:25 PM
CDISC-1347
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 15 Aug 2014 12:28 PM
CDISC-1348
Erin (on behalf of Carol Detrisac)
Modify Existing Term
Friday, 15 Aug 2014 12:31 PM
CDISC-1349
Erin Muhlbradt
Modify Existing Term
Open NCI EVS
Open NCI EVS
Open NCI EVS
Open NCI EVS
Open NCI EVS
Friday, 15 Aug 2014 12:36 PM
CDISC-1350
Erin Muhlbradt
Modify Existing Term
Friday, 15 Aug 2014 12:37 PM
CDISC-1351
Erin Muhlbradt
Modify Existing Term
Friday, 15 Aug 2014 12:38 PM
CDISC-1352
Erin Muhlbradt
Modify Existing Term
Friday, 15 Aug 2014 12:39 PM
CDISC-1353
Erin Muhlbradt
Modify Existing Term
Friday, 15 Aug 2014 12:41 PM
CDISC-1354
Erin Muhlbradt
Modify Existing Term
Open NCI EVS
Open NCI EVS
Open NCI EVS
Open NCI EVS
Open Gary Walker Quintiles, Inc.
Open
Friday, 15 Aug 2014 12:44 PM
CDISC-1355
Erin Muhlbradt
Modify Existing Term
Friday, 15 Aug 2014 12:47 PM
CDISC-1356
Erin Muhlbradt
Modify Existing Term
Friday, 15 Aug 2014 12:48 PM
CDISC-1357
Erin Muhlbradt
Modify Existing Term
Friday, 15 Aug 2014 12:49 PM
CDISC-1358
Erin Muhlbradt
Modify Existing Term
Friday, 22 Aug 2014 01:42 PM
CDISC-1359
Create New Term
Friday, 22 Aug 2014 03:01 PM
CDISC-1360
Marcelina Hungria (on behalf of the SDTM Ophthalmology Team)
DIcore Group, LLC
Create New Term
Open
Open
Open Other
Open Charles River
Open Bob Dempsey CDISC
Friday, 22 Aug 2014 03:02 PM
CDISC-1361
Marcelina Hungria (on behalf of the SDTM Ophthalmology Team)
DIcore Group, LLC
Modify Existing Term
Friday, 22 Aug 2014 03:03 PM
CDISC-1362
Lacey Wallace
Eli Lilly and Company
Create New Term
Friday, 22 Aug 2014 03:05 PM
CDISC-1363
Lorraine Spencer
Takeda Pharmaceuticals
Friday, 22 Aug 2014 03:07 PM
CDISC-1364
Audrey Walker
Create New Term
Friday, 29 Aug 2014 01:15 PM
CDISC-1365
Create New Term
Open NCI EVS
Open NCI EVS
Open NCI EVS
Open
Open Merck
Friday, 29 Aug 2014 01:16 PM
CDISC-1366
Erin Muhlbradt
Modify Existing Term
Friday, 29 Aug 2014 01:43 PM
CDISC-1367
Erin Muhlbradt
Modify Existing Term
Friday, 29 Aug 2014 01:44 PM
CDISC-1368
Erin Muhlbradt
Modify Existing Term
Friday, 29 Aug 2014 01:45 PM
CDISC-1369
Marcelina Hungria / Ophthalmology Sub-team
DIcore Group, LLC
Create New Term
Friday, 29 Aug 2014 01:47 PM
CDISC-1370
Debbie O'Neill
Create New Term
Open Friday, 29 Aug 2014 01:49 PM
CDISC-1371
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open
Open
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Friday, 29 Aug 2014 01:49 PM
CDISC-1372
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 29 Aug 2014 01:50 PM
CDISC-1373
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 29 Aug 2014 01:51 PM
CDISC-1374
Create New Term
Friday, 29 Aug 2014 01:52 PM
CDISC-1375
Modify Existing Term
Friday, 29 Aug 2014 01:55 PM
CDISC-1376
Modify Existing Term
Friday, 29 Aug 2014 01:55 PM
CDISC-1377
Create New Term
Friday, 29 Aug 2014 01:56 PM
CDISC-1378
Modify Existing Term
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Bernice Yost CDISC
Open Steve Kopko CDISC
Open Steve Kopko CDISC
Open Steve Kopko CDISC Other
Open NCI EVS
Open NCI EVS
Friday, 29 Aug 2014 01:58 PM
CDISC-1379
Create New Term
Friday, 29 Aug 2014 01:59 PM
CDISC-1380
Create New Term
Friday, 5 Sep 2014 02:31 PM
CDISC-1381
Create New Term
Friday, 5 Sep 2014 02:32 PM
CDISC-1382
Modify Existing Term
Friday, 5 Sep 2014 02:34 PM
CDISC-1383
Modify Existing Term
Friday, 5 Sep 2014 02:36 PM
CDISC-1384
Create New Term
Friday, 5 Sep 2014 02:37 PM
CDISC-1385
Friday, 5 Sep 2014 02:39 PM
CDISC-1386
Erin Muhlbradt
Modify Existing Term
Friday, 5 Sep 2014 02:40 PM
CDISC-1387
Erin Muhlbradt
Modify Existing Term
Open Colleen Bonjo Merck Other
Open Astrazeneca
Open Merck
Friday, 5 Sep 2014 02:41 PM
CDISC-1388
Friday, 5 Sep 2014 02:42 PM
CDISC-1389
Anna Pron-Zwick
Create New Term
Thursday, 11 Sep 2014 07:19 PM
CDISC-1390
Debbie O'Neill
Create New Term
Open Pfizer
Open
Open
Open Biogen Idec
Open
Thursday, 11 Sep 2014 07:21 PM
CDISC-1391
Roberta Rosenberg
Create New Term
Thursday, 11 Sep 2014 07:23 PM
CDISC-1392
Lacey Wallace
Eli Lilly and Company
Modify Existing Term
Thursday, 11 Sep 2014 07:25 PM
CDISC-1393
Takahiro Takeuchi (竹内崇裕)
Otsuka Pharmaceutical Co., Ltd.
Create New Term
Thursday, 11 Sep 2014 07:26 PM
CDISC-1394
Scott Bahlavooni
Create New Term
Thursday, 11 Sep 2014 07:28 PM
CDISC-1395
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open
Open NCI EVS
Open NCI EVS
Open
Open
Open
Open
Open
Open
Thursday, 11 Sep 2014 07:28 PM
CDISC-1396
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:29 PM
CDISC-1397
Erin Muhlbradt (on behalf of Lab team)
Modify Existing Term
Thursday, 11 Sep 2014 07:30 PM
CDISC-1398
Erin Muhlbradt (on behalf of Lab team)
Modify Existing Term
Thursday, 11 Sep 2014 07:31 PM
CDISC-1399
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:32 PM
CDISC-1400
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:32 PM
CDISC-1401
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:33 PM
CDISC-1402
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:33 PM
CDISC-1403
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:33 PM
CDISC-1404
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Open
Open
Open
Open
Open
Open NCI EVS
Open NCI EVS
Open CDISC
Thursday, 11 Sep 2014 07:34 PM
CDISC-1405
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:35 PM
CDISC-1406
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:35 PM
CDISC-1407
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:36 PM
CDISC-1408
Sharon Broderic
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Thursday, 11 Sep 2014 07:36 PM
CDISC-1409
Sharon Broderic
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Friday, 12 Sep 2014 12:35 PM
CDISC-1410
Erin Muhlbradt (on behalf of SEND Repro team)
Modify Existing Term
Friday, 12 Sep 2014 12:37 PM
CDISC-1411
Erin Muhlbradt (on behalf of SEND Repro team)
Modify Existing Term
Friday, 12 Sep 2014 12:44 PM
CDISC-1412
Robert Dempsey
Modify Existing Term
Open Merck
Open Gordon Krall Allergan
Open Bess LeRoy C-Path
Open Charles River
Open Pam Harvey CDISC
Open Pam Harvey CDISC
Open
Open Dennis Noe
Friday, 19 Sep 2014 03:22 PM
CDISC-1413
Debbie O'Neill
Create New Term
Friday, 19 Sep 2014 03:24 PM
CDISC-1414
Create New Term
Friday, 19 Sep 2014 03:24 PM
CDISC-1415
Create New Term
Friday, 19 Sep 2014 03:27 PM
CDISC-1416
Audrey Walker
Create New Term
Friday, 19 Sep 2014 03:28 PM
CDISC-1417
Create New Codelist
Friday, 19 Sep 2014 03:29 PM
CDISC-1418
Create New Codelist
Friday, 19 Sep 2014 03:30 PM
CDISC-1419
Sharon Broderick
Boehringer Ingelheim Pharmaceuticals, Inc.
Create New Term
Monday, 22 Sep 2014 10:08 AM
CDISC-1420
Takeda Pharmaceuticals Intl Co
Create New Term
Open Dennis Noe
Open Dennis Noe
Open Merck
Open
Monday, 22 Sep 2014 10:13 AM
CDISC-1421
Takeda Pharmaceuticals Intl Co
Create New Term
Monday, 22 Sep 2014 10:15 AM
CDISC-1422
Takeda Pharmaceuticals Intl Co
Modify Existing Term
Friday, 26 Sep 2014 02:38 PM
CDISC-1423
Debbie O'Neill
Create New Term
Friday, 26 Sep 2014 03:37 PM
CDISC-1424
Takashi Ojima
Otsuka Pharmaceutical Co., Ltd.
Create New Term
Open
Open Bess LeRoy C-Path
Friday, 26 Sep 2014 03:38 PM
CDISC-1425
Takashi Ojima
Otsuka Pharmaceutical Co., Ltd.
Create New Term
Friday, 26 Sep 2014 03:41 PM
CDISC-1426
Create New Term
New Term or Codelist/Existing Term or Code Number
New
Change code in column A from 101829 to C101829
LIPASE
SEND-SPEC EYE, AQUEOUS and BULBAR CONJUNCTIVA
Please see attached spreadsheet.
CDISC Codelist
SDTM-LBTEST
Change CDISC Definition for Code=C74686 to match what it is for LBTESTCD Code=C74686
SDTM-LBTEST
Change NCI Preferred Term for LBTEST Code=C64488 to have it match what it is for LBTESTCD Code=C64488
SDTM-PKUNIT
Remove carriage return character from PKUNIT COde=C111264
New Morphology Findings Domain Test Code/Test Name codelist
SDTM-PKUNIT
Change NCI Preferred Term for PKUNIT Code=C67372 to 'Gram per 24 Hours' and for PKUNIT Code=C67410 to 'Milliliter per 24 Hours'. Add Synonym to PKUNIT Code=73742 as 'Milligram per Minute'.
SDTM-PKUNIT
Update NCI Preferred Term and CDISC Definition for PKUNIT Code=C85641. Both do not match the current Submission Value.
QS-SOWS Subjective Test
SDTM-LBTEST
C67154/C65047 Laboratoy Test - CDISC definition mistmacht for code C74686
SDTM-LBTEST
SDTM-METHOD
SDTM-UNIT C67255; Synonym
C49670; Synonym
SDTM-LOC C12499; NCI Preferred Term
C64488; NCI Preferred Term
C74686; Definition
SDTM-FRM C42928; Definition
C67372; NCI Preferred Term
C111264; CDISC Submission Value
C67410; NCI Preferred Term
C71059; NCI Preferred Term
SEND-SPEC C12499; NCI Preferred Term in SEND file
SDTM-LOC
SDTM-VSSTRESU
SDTM-LBTEST
SDTM-LBTEST
SDTM-PKUNIT
SDTM-PKUNIT
SDTM-PKUNIT
QS-KFSS TEST; QS-KFSS TESTCD
Modify several TEST values and CDISC Definitions for the Kurtzke Functional Systems Scores Questionnaire.
QS-KFSS TEST; QS-KFSS TESTCD
Also add terms for an additional two questions that are in the original KFSS questionnaire but were missing on the CRF that was used to create the KFSS terminology. See the emailed Excel spreadsheet for details.
Remove terms C52749; C52758; C52754; C12295 from Anatomical Location.
C73742; Synonym
C49671; Synonym
C112395; synonym
C112326; synonym
C112267; synonym
QS-QSCAT C112523; definition
SDTM-LOC Multiple Terms Submitted in separate email
SDTM-LOC GASTRIC
SDTM-FREQ EVERY 7 WEEKS
SDTM-UNIT
SDTM-PKUNIT
SDTM-VSSTRESU
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-MICROORG
/YEAR; mL/mmHg/min/L; mmol/min/kPa; mmol/min/kPa/L
IN SITU HYBRIDIZATION
Intraventricular and Intraatrial Conduction
SDTM-UNIT Change C102404 to C25397
Re-code C2271 to C581 (Insulin)
SDTM-UNIT /nL
FT
SDTM-METHOD
SDTM-EGTEST
PR INTERVAL; RR INTERVAL; QRS INTERVAL; QT INTERVAL
SDTM-EGTEST
SDTM-DIABTHPY
SDTM-DOMAIN
QS-GAD7 TEST/TESTCD; QS-PHQ-9 TEST/TESTCD
Add term to QS GAD-7 code lists and PHQ-9 code lists for total score.
PHOTOTOXICITY
SDTM-LOC
SDTM-DIR NASAL
SDTM-DIR TEMPORAL
New SEND LBTESTCD and LBTEST for excretion tests.
SEND-SSTYPE
SEND-NEOPLASM
TRICHOFOLLICULOMA, BENIGN; TRICHOEPITHELIOMA, BENIGN; TRICHOEPITHELIOMA, MALIGNANT; TRICHOLEMMOMA, BENIGN; TRICHOLEMMOMA, MALIGNANT; PILOMATRICOMA, BENIGN; PILOMATRICOMA, MALIGNANT
Multiple Anatomical Location terms - File emailed separately
SEND-NEOPLASM
Re-assign c-codes for a handful of concepts in the Neoplasm codelist. These are experimental organism concepts only and should be specified as such in the NCI PT.
SDTM-LBTEST
C56270 and C85627 are mathematically synonymous.
C85710 mg/L/mg
SDTM-LOC retinal nerve fiber layer
SEND-SPEC PALPEBRAL CONJUNCTIVA
VGPR
Knee Height
SDTM-DOMAIN
DD synonym and definition is wrong in CT. Should be Death Details (not Death Diagnosis) and definition should be: This domain captures information pertaining to the death of a subject.
SDTM-DOMAIN
HO domain is new in SDTM IG. Should be Healthcare Encounters. Definition is: The Healthcare Encounters dataset includes inpatient and outpatient healthcare events.
SDTM-PKUNIT
SDTM-PKUNIT
SDTM-RSSTRESC
SDTM-VSTEST
SDTM-EGSTRESC
HEARTBEATS PREMATURE; PACEMAKER GENERATED ARRHYTHMIA
Please correct the NCI Preferred Term about Calcium.
C16634; NCI Preferred Term needs to change.
SDTM-UNIT
Ideal Weight
IDEALWT
mm
SDTM-UNIT cells/nL
SDTM-EGSTRESC
Please either remove one or clarify the need for 2 seemingly identical result codes: SINUS RHYTHM, NORMAL SINUS RHYTHM
SDTM-LBTEST
SDTM-COUNTRY
Please add CIGAR, CIGARETTE, and PIPE to the UNIT codelist or provide guidance for SDTM Submission values for collecting the number of a given substance smoked.
SDTM-SCTEST
SDTM-SCTESTCD
SDTM-LBTEST
Request for new SDTM_LBTEST and SDTM_LBTESTCD entries submitted in a separate e-mail titled CDSIC Controlled Terminology Multiple Term Request Speadsheet SharonBroderick 24Feb2014.
SDTM-VSRESU
SDTM-LBTEST
C Reactive Protein, High Sensitivity (Test Code: CRPHS)
SDTM-LBTESTCD
C98869 - please consider changing code to PLSCECE (see additional information)
New
SDTM-UNIT 10^6/mm3
SDTM-UNIT Update definition for um3
SDTM-UNIT cubic micron
SDTM-UNIT
DARTSEX (Nonclinical DART Sex): To be used as the Standardized Result (--STRESC) of tests for determining the sex of fetuses and/or neonates in Developmental and Reproductive Toxicology studies. Currently used in the draft FX domain (Fetal Pathology Exami
SDTM-LBTEST
Request for new LBTEST and LBTESTCD for SEND use. Microalbumin, segmented leukocytes, and semi quantitative bilirubin
For SEND use, C64526 and C67069 appear synonymous.
New Disability Rating Scale (DRS) Questionnaire
New Microscopic Test Terminology
Keratoacanthoma, Benign
HEMOLYMPHORETICULAR TUMOR
SDTM-UNIT RIU - Relative Intensity Unit
SDTM-LBTESTCD
New LBTESTCD and LBTEST for SEND use for segmented and non-segmented neutrophils percent
SEND-NEOPLASM
SEND-NEOPLASM
SDTM-UNIT BU; Synonym = Bethesda Unit
SDTM-UNIT GPL-U/ml
SDTM-UNIT MPL-U/ml
SDTM-LOC multiple
SDTM-UNIT
Multiple
QS-QSCAT Questionnaire Category codelist rows
SDTM-LBTEST
1. Can a term be added for Total Protein? Or can Total Protein be in the synonym? 2. The LBTESTCD Bili refers to Bilirubin. Can LBTEST be set to Total Bilirubin?
The lab terminology team would like to remove C67242 - cells/uL
For all of QS: Codelist Name column: all rows, (except for the Questionnaire Category codelist rows)
BIOPSY; ASPIRATION
MUGA
New
Coronary Angiography; Peripheral Angiography
New
PRESENT; ABSENT
New
SDTM-PROCEDUR
SDTM-EGTEST
Please reduce length of new EGTEST value of EGTEST='Intraventricular and Intraatrial Conduction' which has a length of 43 characters.
SDTM-METHOD
Request to add the existing terms, in the attached file, to the new Species codelist.
SDTM-METHOD
Creating a new code list for the TBI TA project for Satisfaction With Life Scale Questionnaire
SDTM-LBTEST; SDTM-LBTESTCD
C74664; Change definition for consistency with other YEAST terms
SDTM-LBSTRESC
Please find attached a request for 2 new ADaM codelists Analysis Reason and Analysis Purpose
IMMUNO FLORESCENCE TEST
New new term for QSCAT and new MPAI codelist
SDTM-UNIT BAR
SDTM-UNIT Cup (unit of volume)
Multiple MS TA - Multiple Term Request
New GOSE - Extended Glasgow Outcome Scale
SEND-DSDECOD
DSDECOD definition changes for the Repro Pilot Terminology only. Not for public review until the Repro pilot is completed and the final feedback received.
SDTM-METHOD
CDISC-CLINDE Glossary
Remove the CDISC Clinical Data Element Glossary from CDISC terminology.
SDTM-SPCIES
The Virology CT team requested disease specific bacteria species from Jordan (NCI). See attached list from Jordan.
SDTM-LBTEST
Is CDISC developing controlled terminology to support the representation of flow cytometry-based biomarkers?
SDTM-METHOD
Please add the following sentence to the definition for Microarray. "Used when a more specific microarray methodology is not specified."
New
Multiple File emailed separatly
Varicella Zoster Virus DNA (test code: VZVDNA)
SDTM-LOC File emailed separately
Multiple See atttached multi-term request
ENDARTERECTOMY; CARDIAC STENT PLACEMENT
SDTM-UNIT /pL
SDTM-UNIT mmol/mol HGB
SDTM-UNIT NO UNIT
Please add COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) Lifetime/Recent Version Version 1/14/09 to the Questionnaire Category (QSCAT) codelist and add new Test Code and Test Name codelists with values for this scale to the QS Terminology.
SDTM-LBTEST
SDTM-PROCEDUR
Multiple File emailed separately
Antimitochondrial Antibody Subtype 2
Anti-Neutrophil Cytoplasmic Antibody
Bactericidal/Permeability-Increasing Protein Antibody
Cathepsin Antibody
Elastase Antibody
Inactivated blood coagulation factor-II
Lactoferrin Antibody
Lysozyme
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
Nucleosome Antibody
Proliferating Cell Nuclear Antigen
Polymyositis -Scl Antibody
Proteinase-3-Antibody
Ribosomal P Protein Antibody
Ribonucleoprotein-70 Antibody
Ribonucleoprotein - Smith Complex Antibody
Sjogrens SS-A52 Antibody
Sjogrens SS-A60 Antibody
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-LBTEST; SDTM-LBTESTCD
SDTM-UNIT
Change C16805 to C16290
Multiple SDTM-LBTEST; SDTM-LOC - File emailed separately
RADIAL IMMUNODIFFUSION
ANGIOGRAM
Intraventricular and Intraatrial Conduction
MIU - part of the E2B units of measure terminology and CDISC has not published it yet. Synonym of iu(1,000,000s) [From E2B
SDTM-METHOD
SDTM-METHOD
SDTM-METHOD
SDTM-NCOMPLT
Re-open discussion about the Submission value change in P17 from PROTOCOL VIOLATION to PROTOCOL DEVIATION (C48251). This has caused some consternation in the user community.
SDTM-EGTEST
Calcium Corrected for Albumin
EGTESTCD = EGFND / EGTESTCD = ECG Findings
SDTM-UNIT dpm/0.5 mL
Multiple QS Domain
Estrogen Receptor
Human Epidermal Growth Factor Receptor 2
SDTM-LBTEST
SDTM-EGTEST/CD
SDTM-MITEST/CD
SDTM-MITEST/CD
Ki-67
Progesterone Receptor
Multiple
SDTM-MITEST/CD
SDTM-MITEST/CD
QS-HADS TEST and QS-HADS TESTCD, need variables for subtotals, found in author's documentation and printed versions
SDTM-TSPARM/CD
The definition for TSPARMCD=REGID; TSPARM=Registry Identifier, has a typo that should be fixed.
SDTM-LBTEST/CD
HBVVLD (C92542) and HBDNA (C103404) I think are used synonymously. HBVVLD mesaures the amount of Hep B DNA in a specimen and I am not sure how HBDNA differs.
SDTM-UNIT umol/dL; IU/dL; umol/L/min
SDTM-UNIT kg/cm
SDTM-UNIT m/sec2
SDTM-LOC Knee
SDTM-LBTEST/CD
Urinalysis Macroscopic Examination (TESTCD: UAMAEXAM)
SDTM-DECAT
The submission value for C62954 and C112361 needs to be in upper-case.
QSCAT: QS-PBI
Update Category Name = BPI SHORT FORM to read as BPI SHORT FORM (24H)
Failure to meet protocol continuation criteria
SDTM-LOC
SEND-DSDECOD
SDTM-SPECTYPE
Please add BUFFY COAT to the SDTM Specimen Type CL
SDTM-METHOD
Please add HEPATITIS C VIRUS RECOMBINANT IMMUNOBLOT ASSAY to SDTM Method Codelist
SEND-OMTEST/CD
Please make the SEND OMTEST and OMTESTCD codelists extensible [Change Property from No to Yes]
SEND wants to re-use some concepts from the SDTM-LOC codelist for the SEND-SPEC codelist. The definitions as published now are too human-centric.
SEND-SPECIES
Add new Term COTTON RAT (C77117) to SEND-SPECIES codelist
SEND-STRAIN
SEND team has agreed to proposed updates to the STRAIN codelist.
Multiple
Multiple
Please consider adding the following term: Fluoride
Addition of 3 new codelists and associated terms for SEND MI variables including NONNEO, CHRNCTY, DSTRBN. SEND team has developed and finalized these terms and they will go out for P19 public review.
Addition of 4 new codelists and associated terms for SEND safety pharm work including SCVTST, SCVTSTCD, SRETST, SRETSTCD. SEND team has developed and finalized these terms and they will go out for P19 public review.
SDTM-LBTEST/CD
SEND-NEOPLASM
Remove the word MIXED and CARCINOMA from "CARCINOMA, MIXED, ACINAR-ISLET CELL, MALIGNANT" and add TUMOR after "CELL". C6878
New
SDTM-LBTEST/CD
Naming convention question for Viral Load, DNA and RNA terms
SEND Repro team would like to include the following terms in the new codelist FXSTRESC for fetal findings terminology.
SEND-SPEC Several new SPEC terms with definitions suggested
SEND-SPEC Request to differentiate between treated and untreated Skin and Skin/Subcutis
Functional Tests (FT)
Procedure Agents (AG)
FI02/Fraction of Inspired Oxygen
SAO2/Arterial Oxygen Saturation
SDTM-UNIT Points
SDTM-LOC Multiple terms request
SDTM-UNIT Multiple terms request
EGALL
Tumor Response Result: Please remove NA, C48660
Breathalyzer
Multiple Add 3 new terms to LBTEST/CD and UNIT codelists
SDTM-DOMAIN
SDTM-DOMAIN
SDTM-LBTEST/CD
SDTM-LBTEST/CD
PAO2FIO2/Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen
SDTM-LBTEST/CD
SDTM-EGTEST/CD
SDTM-LBTEST/CD
New LBTESTCD = CTX11CRT New LBTEST = Type II Collagen C-Telopeptides/Creatinine
SDTM-MEDEVAL
INTERVIEWER, SINGLE PROFESSIONAL, PROFESSIONAL CONSENSUS, PERSON WITH BRAIN INJURY, SIGNIFICANT OTHER
SDTM-RSSTRESC
SDTM-METHOD
SEND-SPEC preputial/clitoral gland
LBTEST = Interleukin 1 Alpha; LBTESTCD = INTLK1A
BPI SHORT FORM - Category (QSCAT)
Add terms to LBTEST/CD
TRANSPOSON
SDTM-DECAT
Please make the following CDISC Submission Value terms uppercase: C62954 Device Operational Issue C112361 Non-Study Equipment Issue
SDTM-LBTEST/CD
QS-BPI Short Form TEST
SDTM-LBTEST/CD
SDTM-GENSMP
SDTM-TSPARM/CD
TSPARM-CD. Multiple new term requests for Trial Summary Parameter Test Codes and Test Names.
MELD Score
SDTM-UNIT ug/mmol
Multiple New terms add to multiple codelists
SDTM-LBTEST/CD
Multiple New QS Codelist = BPI Short Form (7D)
Angiography
Add terms to C-SSRS Children's Baseline
Add terms to C-SSRS Children's Baseline/Screening
Add terms to C-SSRS Children's Since Last Visit
Add terms to C-SSRS Screening
SDTM-NRIND
Add 'LOW PANIC', 'LOW NORMAL', 'HIGH NORMAL', and 'HIGH PANIC'
SDTM-METHOD
QS-C-SSRS Children's Baseline TEST/CD
QS-C-SSRS Children's Baseline/Screening TEST/CD
QS-C-SSRS Children's Since Last Visit TEST/CD
QS-C-SSRS Screening TEST/CD
Add terms to FAQ
Add terms to FAQ-NACC
Add terms to MRS
Add terms to SDS
Add terms to AQ20
Add term to QS-DS
Add term to QS-EDSS
Add terms to FAMS
Add terms to KFSS
Add terms to MHIS-NACC
Add term to QS-PDDS
Multiple
Add new terms to VFQ24-IA
Add new terms to VFQ25-SA
QS-QSCAT Add terms to QS-BLCS
QS-QSCAT Add terms to QS-BORG CR-10 Scale
QS-QSCAT Add terms to QS-BWCS
QS-FAQ TEST/CD
QS-FAQ-NACC Version TEST/CD
QS-MRS TEST/CD
QS-SDS TEST/CD
QS-AQ20 TEST/CD
QS-Disease Steps TEST/CD
QS-EDSS TEST/CD
QS-FAMS TEST/CD
QS-KFSS TEST/CD
QS-MHIS-NACC TEST/CD
QS-PDDS TEST/CD
Add terms to QS-SGRQ Past 3 months Add terms to QS-SGRQ Past 4 weeks
QS-VFQ25-Interviewer Administered TEST/CD
QS-VFQ25-Self Administered TEST/CD
QS-QSCAT
QS-QSCAT Add terms to QS-EQ-5D-3L
QS-QSCAT Add terms to QS-EQ-5D-5L
QS-QSCAT Add terms to QS-FSS
QS-QSCAT Add terms to QS-IVIS
QS-QSCAT Add terms to QS-MFIS
QS-QSCAT Add terms to QS-MSQOL-54
QS-QSCAT Add terms to RAND-36 V1.0
New Add terms to FT-CAT SIXMW
QS-QSCAT Add terms to QS-DRS
QS-QSCAT Add terms to QS-GOSE
New Add new terms to FTCAT QS-HAI
QS-QSCAT Add terms to QS-MPAI
New Add terms to FTCAT QS-NHPT
New Add terms to FTCAT QS-PASAT
New Add term to FTCAT QS-SDMT
QS-QSCAT Add new terms to QS-SWLS
New Add terms to FTCAT QS-T25FW
New Add term to FTCAT QS-TUG
SDTM-UNIT
Add terms to QS-C-SSRS Pediatrc/Cognitively Impaired Lifetime/Recent
Change submission term for the unit concept uIU/mL to mIU/L since the latter is SI compliant and the former is not
SDTM-UNIT CH50 unit
SDTM-EVAL PROXY
SDTM-UNIT nmol/day
Oronasal Inhalation
WholeBody, Inhalation
SDTM-UNIT Add new terms to the Unit Codelist
SEND-SPEC Update CDISC DEF for C84507/BUFFY COAT
New DLQI to be added to QS Domain
New
New
New
SDTM-ROUTE
SDTM-ROUTE
EORTC QLQ-MY20 to be added to QS Domain terminology
Asthma Control Diary (ACD )to be added to QS Domain terminology
SF-36 V2 Acute to be added to QS Domain terminology
New
SDTM-UNIT
New
New FACT-Bl to be added to QS Domain
New Request FACT-G to be added to QS Domain
New
New Request FACT-Taxane to be added to QS Domain
Multiple LBTESTCD and LBTEST
SDTM-UNIT C67380, IU/mg, International Unit per Milligram
New QSCAT and Codelist for CHART-SF questionnaire used in traumatic brain injury assessment.
C48475 Submission Value currently is BAR (A dosing measurement based on the bar unit.). The lab terminology team would like to change the submission value to DBAR. BAR is for the BAR Unit of Pressure, which is currently being added as a new unit code.
FACT-B: For patients with Breast cancer to be added to QS Domain terminology
Request NCCN-FACT FBSI-16 to be added to QS Domain
SDTM-LBTEST/CD
New synonym for existing term "Smooth Muscle Antibody". Add "F-Actin Antibody
SDTM-RETEST
New test and test codes for the Respiratory Test Codelists
Multiple
CYTOMEGALOVIRUS
Update SY for Pseudocowpox Virus
APP, APPA, APPB
Add new terms to LBTEST/CD codelist
Add new CDISC SY
Add new terms to MICROORG codelist
hispidus, fulviventer
Add 4 new TEST/CDs to FIQR
Add 2 new TEST/CDs to HADS
C101002 C101002 C105250 C107075 C106752 C111553 C111417 C113932 C101001 C105249 C103796 C107073 C107074 C106750 C106751
SDTM-MICROORG
SDTM-MICROORG
SDTM-LBTEST/CD
SDTM-LBTEST/CD
SDTM-LBTEST/CD
SDTM-MICROORG
SEND-STRAIN
QS-FIQR TEST/CD
QS-HADS TEST/CD
Multiple
Multiple
SDTM-RACE Add new terms to the RACE codelist
ENTEROBACTER TAYLORAE
New Term Request = Disease Outcome: Virologic Failure, Sustained Virologic Response
New Codelist Request = Transplant Outcome; and two new terms in this codelist: Success, Re-Transplant
SDTM-MICROORG
Influenza TA - New terms to be added
SDTM-UNIT
SEND-SPEC Muscle, Long digital extensor
SDTM-LBTEST/CD
LBTESTCD= CD161ALY, CD45RALY, CD34LY, CD38LY, CD161LY, and CD45LY
SDTM-CVEXAM/CD
Why is the controlled terminology called 'CVEXAMCD/CVEXAM' when it is attached to the CVTESTCD/CVTEST variables?
SDTM-RETEST/CD
For C105485, C105486, and C85744, please remove Creatinine from the submission value, synonym, and definition.
Multiple Education level and years of education
Please remove NAG as a synonym from C103419
SEND-STSPRM/CD
Short form: TOTSUBJ Long form: Total Number of Subject purchased
SDTM-LBTEST/CD
SDTM-LOC Update C12389, Esophagus CDISC Definition
Multiple CDISC Submission Value should be capitalized
C42554 Ohm
SDTM-LOC Multiple Term Request for LOC
change CVEXAMCD (C101847) to CVTESTCD
Change CVEXAM (C101846) to CVTEST
Short form: CONSC Long form: Contributing Scientist
needle tract lesion
SDTM-LBTEST/CD
PREALB - Prealbumin - delete this term and create it as a new term of TTR -'Transthyretin'.
SDTM-VSRESU
SDTM-CVEXAMCD
SDTM-CVEXAM
SEND-STSPRM/CD
SEND-NEOPLASM
Multiple
SDTM-FREQ Term: ONCE
SDTM-SPECTYPE
CORD BLOOD; CORD SERUM; GASTRIC SECRETION; GASTRIC JUICE; VAGINAL FLUID
SDTM-VSRESU
Change C48500 CDISC Submission Value from "IN" to "in"
SDTM-DSCAT
The SDS Extended Leadership team is requesting that the DSCAT codelist be made NOT EXTENSIBLE.
SDTM-DATESTCD
The SDS Extended Leadership team is concerned about having the DATESTCD codelist extensible. There are two entries: "Dispensed Amount" and "Returned Amount"
Multiple changes to definitions associated with different C-SSRS QS instruments.
Multiple
Please add ASL FUNCTIONAL MRI to SDTM METHOD
add NA
Codelist MOTESTCD/MOTEST are not present in the drop-down. Please add ICV and Intracranial Volume to MOTESTCD and MOTEST codelist respectively
SDTM-METHOD
SDTM-EGLEAD
The CDISC Definition for AUCPEO is incorrect
Multiple
SDTM-UNIT
SDTM-UNIT
Multiple RETEST Multiple term request
SDTM-LOC FACE C13071
SDTM-LOC C12671 Forelimb
SDTM-PKPARM/CD
Adoption of ICD-O-3 Sites and Histologies, in addition to the existing "Neoplasm Type" that combines the information for sites and histologies
For NCI code C67255 please add 'GI/L' to the list of CDISC synonyms. For NCI code C67308 please add 'TI/L' to the list of CDISC synonyms.
Add new terms to the Unit codelist; Sent a separate eMail to Bernice Yost and Erin Muhlbradt containing list of new unit terms requested.
SDTM-RETEST/CD
RETEST = Peak Nasal Inspiratory Flow RETESTCD = PNIF
SEND-SPEC C77625 HINDLIMB
SEND-SPEC C12725 Gonad
uM
SDTM-UNIT g/mmol Creatinine
SDTM-UNIT New terms to be added to the UNIT Codelist
SDTM-PKUNIT
SDTM-MICROORG
Hepatitis C Virus RNA is missing from lab codelist and "Hepatitis G Virus" is missing from micro org codelist"
SDTM-RETEST/CD
RETEST = Predicted Peak Expiratory Flow RETESTCD = PEFPR
Multiple New multiple term request
SDTM-CVEXAMCD
COARTDOM Coronary Artery Dominance: the synonym Coronary Anatomy Dominance should be removed.
SDTM-CVEXAM
Remove Coronary Anatomy Dominance from the synonyms.
SDTM-PKPARM/CD
PKPARMCD and PKPARM: remove Hemodialysis CL from the synonyms.
SDTM-PKPARM/CD
PKPARM and PKPARMCD: for C85575, Average Conc: please change the submission value to Average Concentration for PKPARM and remove the synonym of Average Conc for PKPARM and PKPARMCD.
SDTM-VSTEST/CD
VSTEST and VSTESTCD: C84372, Knee to Heel Length - please remove the synonym of lower leg length.
SDTM-DUTEST/CD
C74298, Field of View - please remove the synonym of FOV.
SEND-SPEC
SDTM-LOC
SDTM-TSPARM/CD
TSPARM and TSPARMCD: C49696, Sex of Participants - please remove the synonym of Sex Of Participants.
SDTM-VSTEST/CD
VSTEST and VSTESTCD: C12472, testcd = BODYFAT, testname = Adipose Tissue. Usually the test code is an abbreviation of the test name. But not in this case - WHY?
SDTM-DUTEST/CD
DUTEST and DUTESTCD: C106563, Receiver Bandwidth - please remove the synonym of RXBW and rBW
Update definitions for C12392, C12468, C13272 and C12782. The repro team made updates to simplify or de-specify the definitions.
Repro team suggests updates to definitions C12392, C12468, and C12782 to simplify or remove human-specific information from the definition. These terms are also in the SEND-SPEC and new (under development) SEND-FXLOC codelists.
CARDIAC CATHETERIZATION
Pdu
CYTOMEGALOVIRUS CULTURE
Add new terms to the MICROORG Codelist
SEND-NEOPLASM
C9003 and C4049: There are spaces before commas in the CDISC Submission value. This is a type I request to remove them.
SDTM-TRTEST
C103421 and C104441; Changes to these terms removed from P19. Discuss the phrase 'by other methods or modalities' in these two definition. Discuss the change to the submission value
SDTM-METHOD
SDTM-RSSTRESC
SDTM-LBTEST/CD
SDTM-MICROORG
Multiple
Supraventricular Rhythm
NEW OEFOCID
PDc; Non-PD
See attached HEP C TA new term request for Morphology and Microscopy test name and test code.
SDTM-EGTEST/CD
SDTM-RSSTRESC
SDTM-LBTEST/CD
New LBTESTCD and LBTEST terms for DESMOGLEIN 1 Ab and DESMOGLEIN 3 Ab
SDTM-TOXGRV3
Please remove toxicity grading codelist or explain logic for including them in the CT and confirm that we need to submit all grading scales and versions as new CT requests
Clotting Time Homeostasis
Bazett's Correction for beat 1
QTCB1
Bazett's Correction for beat 2
QTCB2
Bazett's Correction for beat 3
QTCB3
SDTM-VSTEST/CD
SDTM-EGTEST
SDTM-EGTESTCD
SDTM-EGTEST
SDTM-EGTESTCD
SDTM-EGTEST
SDTM-EGTESTCD
Bazett's Correction for beat 4
QTCB4
Summary (MEAN) Bazett's Correction
QTCBMEAN
Frederica's Correction for beat 1
QTCF1
Frederica's Correction for beat 2
QTCF2
SDTM-EGTEST
SDTM-EGTESTCD
SDTM-EGTEST
SDTM-EGTESTCD
SDTM-EGTEST
SDTM-EGTESTCD
SDTM-EGTEST
SDTM-EGTESTCD
Frederica's Correction for beat 3
QTCF3
Frederica's Correction for beat 4
QTCF4
Summary (MEAN) Frederica's Correction
QTCFMEAN
LBTESTCD = HIV1RNA LBTEST = HIV-1 RNA
SDTM-EGTEST
SDTM-EGTESTCD
SDTM-EGTEST
SDTM-EGTESTCD
SDTM-EGTEST
SDTM-EGTESTCD
SDTM-LBTEST/CD
Please add "Cardiolipin IgA Antibody" to the LBTEST list. Please also add "CRDIGAAB" to the LBTESTCD list.
SDTM-LBTEST/CD
SDTM-EVAL INFORMANT
SEND-SPEC
SEND-SPEC
Updates to first 100 rows of SEND-SPEC terms to de-specify and remove functional information from published SEND definitions.
Pancreas C12393: SEND Repro team is suggesting a change to definition to de-specify and shorten.
SDTM-LOC
SEND-SPEC
SEND-SPEC
SDTM-LOC
SDTM-LOC
Pancreas C12393: SEND Repro team is suggesting a change to definition to de-specify and shorten.
Pulmonary Artery C12774; Slight update the definition to make it different from Pulmonary Trunk.
Skull C12789; SEND Repro team is suggesting a removal of a synonym as it isn't a 1:1 relationship.
Skull C12789; SEND Repro team is suggesting a removal of a synonym as it isn't a 1:1 relationship.
Small Intestine C12386: SEND Repro team is suggesting a change to definition to de-specify and remove functional information for consistency.
SDTM-LOC
SEND-SPEC
SEND-SPEC
SEND-SPEC
SpO2
Add new terms to the SDTM-Method Codelist
Stomach C12391: SEND Repro team is suggesting a change to definition to de-specify and remove functional information for consistency.
ARTERY, SUBCLAVIAN C33643: De-specify definition. Innominate is used more frequently in animals though is synonmous with Brachiocephalic.
Tail C77663: Repro team wants to update definition. Likes Dorland's better.
Forelimb C12671: Update definition for use in all cases.
SDTM-VSTEST/CD
SDTM-METHOD
Modify 2 terms in the SDTM-Method Codelist
SEND-SPEC Efferent Duct
Spectrophotometry
SDTM-METHOD
SDTM-TCNTRL
Add 3 new terms to the TCNTRL codelist; This is also an urgent request.
SDTM-EGTEST/CD
Summary (Max) Heart Rate (C39779) (Applies to EGTESTCD HRMAX as well); Summary (Min) Heart Rate (C62096) (Applies to EGTESTCD HRMIN as well)
SDTM-METHOD
SDTM-LOC
SDTM-LOC
SEND-SPEC
Multiple OETEST/OETESTCD and MOTEST/MOTESTCD terms
Buprenorphine with the test code BUPREN
Repro team would like to re-use these concepts for non-clinical studies. Therefore, they are suggesting these changes to de-specify the terms and make them more consistently defined based on location (and not structure, function, etc.)
Add synonym to C33816 TRUNK. This is requested by the SEND Repro team.
SEND Repro team would like to propose the following changes to SEND-SPEC terms to de-specify the definitions.
SDTM-LBTEST/CD
HBD2SDTM-LBTESTCD
Human beta-defensin 2
SDTM-UNIT ngeq/mL
Multiple
Multiple
SDTM-UNIT PK team wants to update the CDISC definitions
SDTM-LBTEST
SDTM-CVSLDEXT
See attached Spreadsheet. These terms already exist in the CV Terminology spreadsheet but we need to assign request codes to them.
SDTM-CVSLDEXT
See attached Spreadsheet. These terms already exist in the CV Terminology spreadsheet but we need to assign request codes to them.
Move some existing terms to the Morphology Test codelists.
Move some existing terms to the Morphology Test codelists.
SDTM-UNIT PK team wants to add a new term
Multiple
Multiple Add new terms
Multiple Modify terms
Remove from CVEXAM/CD Codelists
Other Create new terms in MO domain
See attached spreadsheet of CVEXAMCD code-list
COTTON RAT
RAT
This is for the Oncology team. All of these terms are already in the Oncology Terminology Spreadsheet. They are being submitted to get a request number.
SDTM-CVEXAM/CD
SDTM-CVEXAM/CD
SEND-STRAIN
SEND-SPECIES
Multiple
Lysine
Add New terms
CDISC Submission Values that contain a special character
SDTM-LBTEST/CD
SDTM-MICROORG
QS-QSCAT Two new QSCATs requested
SDTM-UNIT For "%" Please add the word 'Percent' as a Synonym.
SDTM-FREQ Add new terms
Retired
SDTM-MOTEST/CD
Please add controlled terminology for Tanner Scale to SDTM MOTESTCD/MOTEST
SDTM-EMPSTAT
Friend
TREATMENT PERIOD 1
TREATMENT PERIOD 2
TREATMENT PERIOD 3
TREATMENT PERIOD 4
TREATMENT PERIOD 5
POST TREATMENT
SDTM-RELSUB
SDTM-LBTEST/CD
C103446: Add synonym to both TEST and TESTCD value that is identical to TEST name: Thyroglobulin
SEND-STSPRM
Proposed updates to CDISC submission values and synonym for the SEND trial summary parameter name and code codelists.
SDTM-EPOCH
SDTM-EPOCH
SDTM-EPOCH
SDTM-EPOCH
SDTM-EPOCH
SDTM-EPOCH
WASHOUT PERIOD 1
WASHOUT PERIOD 2
WASHOUT PERIOD 3
WASHOUT PERIOD 4
WASHOUT PERIOD 5
SEND-SPEC C12998 SPINAL COLUMN
SEND-SPEC
SDTM-EPOCH
SDTM-EPOCH
SDTM-EPOCH
SDTM-EPOCH
SDTM-EPOCH
C13071 FACE; Change the word Chin to Mandible in definition to de-specify the definition.
SDTM-CVPRCIND
C26726 INFECTION Modify CDISC Definition delete '-- (NCI' replace with '. (NCI)'
(mg/kg/day)/(hr*ng/mL)
Multiple
SEND-SPEC LARGE INTESTINE, CECUM WITH CONTENTS
New
Multiple
SDTM-UNIT ug/g
/min
SDTM-MICROORG
ASPERGILLUS TERREUS; RHIZOMUCOR; CANDIDA INTERMEDIA
SDTM-PKUNIT
Attached are the Influenza TA terminology new term request files.
HEP C TA requests a new codelist for Virologic Response
New questionnaires for EXACT-PRO, E-RS, CRQ-SR, CRQ, CAT, SOBDA, CCQ (24 hours and 1 week versions), PGA, and PSQI.
SDTM-PKUNIT
/day
MIDPTLST
18F NaF PET; SPECT SCAN; BONE SCAN
CHEWING
SDTM-PKUNIT
SDTM-PKPARM/CD
SDTM-METHOD
SDTM-ROUTE
INTRAVENOUS AND INTRAMUSCULARSDTM-ROUTE
SDTM-VRTEST/CD
VRTESCD = IC50S/VRTEST = IC50 Subject Sample Result
Detailed Description
I
I
I
III
I
I
Change code in column A from 101829 to C101829 I
one word missing I
III
III
Please see attached spreadsheet. III
Change Type
CDISC Definition was changed for LBTESTCD=C74686, but not for corresponding LBTEST=C74686
Change NCI Preferred Term for LBTEST Code=C64488 to have it match what it is for LBTESTCD Code=C64488
CRLF/ characters were removed from other PKUNIT terms added in 3rd quarter 2013. This is another new one.
I will send the multiple term CDISC Multiple Term Request Spreadsheet to B. Yost.with the new MOTESTs based on the AD, PD and PKD TA data standards.
These were listed as changes maded in 12/20/2013 CT release, but were not made.
The NCI Preferred Term needed to be changed, but instead the CDISC Definition was changed. Now both do not match the Submission Value.
The assay we use for LIPASE will measure any lipase activity in plasma or serum. It cannot determine the origin so it is not specific for pancreatic lipase.
LIPASE should be a new term by itself with a new defintion: A measurement of the lipase in a biological specimen.LBTESTCD LIPASE, LBTEST Lipase
Please consider changing the the CDISC LBTESTCD for Triacylglycerol Lipase to something else like TRIGRLIP.
Please consider adding the follwing terms: EYE, AQUEOUS and BULBAR CONJUNCTIVA
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Change NCI PT to Calcium Measurement I
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Change NCI PT to Milliliter per 24 Hours I
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Remove torr and Torr from published term. This should have been removed with P16 but were not on the spreadsheet for the VSSTRESU codelist.
Remove torr and Torr from published term. This should have been removed with P16 but were not on the spreadsheet for the VSSTRESU codelist.
Update definition to: 'A measurement of the blood in body products such as a urine or stool sample, not detectable on gross examination.' This was already okay'd with P16 but didn't get updated in spreadsheet.
Definition in spreadsheet should have single quotes around shell, not double.
Change NCI PT to Brugada Syndrome Ventricular Arrhythmia by ECG Finding
File emailed separately. I’ve also attached the reference article that the questionnaire was published in and the CRF that will be annotated and posted along with the Supplement for the KFSS.
File emailed separately. I’ve also attached the reference article that the questionnaire was published in and the CRF that will be annotated and posted along with the Supplement for the KFSS.
There is no reason to keep these on the list that the general team can see.
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remove carriage return in synonym column I
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Add synonym 'Milligram per Minute' so that UNIT and PKUNIT codelists are aligned.
make the P in 'per' lowercase to make it consistent with synonym in UNIT codelist.
Remove the term GASTRIC from the Anatomical Location codelist. This term is a descriptor rather than a location. Other descriptor terms, such as Hepatic, were previously removed from this codelist.
Please add the term EVERY 7 WEEKS to the Frequency codelist with the synonym Q7S.
Please add the following terms to the Unit codelist:/YEAR - per yearmL/mmHg/min/L; mmol/min/kPa; mmol/min/kPa/L are units used to capture the results from the diffusing capacity of the lung for carbon monoxide (DLCO)
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Concept merged in NCIt I
Incorrect mapping in NCIt. I
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Our clinical team feel that the similar terms currently available in the CDISC Method dictionary and are found to be too specific, thus the broader term of ?IN SITU HYBRIDIZATION? is required. Existing CDISC terms which were evaluated by the team are:CISH and FISH: CISH is a dual stain (colorimetric and fluorescent) and FISH is a fluorescent stain. Both involve fluorescence that one doesn?t necessarily need to do for in situ hybridization. In situ hybridization could involve colorimetric only. Nucleic acid hybridization: This is a technique where you detect DNA imprinted on a filter paper using a radioactive probe (as opposed to detecting in tissue or cells, as with in situ hybridization)
Please consider adding the following new terms for Veterinary ECGs: EGTEST, EGTESTCD.PR INTERVALRR INTERVALQRS INTERVALQT INTERVALThese are not summary means, summary max, summary min or summary median. We are just selecting on one PR interval, rr interval, QRS interval QT interval and reporting it.
The existing test name Intraventricular and Intraatrial Conduction is greater than 40 characters. Recommend updating test name to Intraventricular Intraatrial Conduction
A volume unit equal to one nanoliter used as a denominator to build a derived unit expressed as a ratio.
Needed for the new "Functional Tests" domain. This domain has gone through internal review and will be reviewed by the SRC in February.
Please consider adding PHOTOTOXICITY to the study type list. III
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Suggestion from INHAND OWG member to add these other types of hair follicle neoplasms to the NEOPLASM codelist.
This term is needed to represent the nasal quadrant of the eye
This term is needed to represent the temporal quadrant of the eye
C65184; C4147; C35382; C3463; C26919; C66772; C67107; C66746 - All of these terms will have new c-codes in the P17 release.
Add the following excretion LBTESTCD, LBTEST and definition. The definition for clearance tests indicate the volume of serum or plasma that would be cleared of the substance by excretion and the calculation considers the amount of the substance recorded in the serum or plasma along with the amount that is excreted. The excretion tests are only measuring the amount of the substance in the urine.
ALBEX: Albumin Excretion: Measurement of albumin being excreted in urine over a defined amount of time.CAEX: Calcium Excretion: Measurement of calcium being excreted in urine over a defined amount of time.CLEX: Chloride Excretion: Measurement of chloride being excreted in urine over a defined amount of time.CREATEX: Creatinine Excretion: Measurement of creatinine being excreted in urine over a defined amount of time.GLUCEX: Glucose Excretion: Measurement of glucose being excreted in urine over a defined amount of time.IRONEX: Iron Excretion: Measurement of iron being excreted in urine over a defined amount of time.PHOSEX: Phosphorus Excretion: Measurement of phosphorus being excreted in urine over a defined amount of time.KEX: Potassium Excretion Measurement of potassium being excreted in urine over a defined amount of time.SODIUMEX: Sodium Excretion: Measurement of sodium being excreted in urine over a defined amount of time.PROTEX: Total Protein Excretion: Measurement of total protein being excreted in urine over a defined amount of time.
Term def is incorrect with respect to IG. II
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Add so that all Conjunctiva parts are on the codelist. III
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Dennis suggests to remove C85620 as it uses the non-standard concentration form "mg/L"; the standard form, "ng/mL" is used in C85627. These terms will be merged in NCIt.
Change submission value of this term from mg/L/mg to ng/mL/mg because this is the PK team's standard form.
Need this for the MS TA standard. Retinal nerve fiber layer thickness is often measured in MS clinical trials.
Please add the term VGPR with the synonym Very Good Partial Response to the Tumor Response Result codelist.
This is a standard response criteria for multiple myeloma (Reference: http://www.myelomabeacon.com/news/2009/03/13/current-information-on-response-criteria-for-multiple-myeloma/)
Requesting this for TB studies for adult subjects who cannot stand, usually because they are weakened by the disease. Apparently there is a validated method to convert knee height to standing height. Here is one source but we are not experts and are happy to defer to you for a standard definition.http://most.ucsf.edu/docs/KneeHghtLegLgth_v1.0pMay2009.pdf
Please add the following terms to the ECG Result codelist:HEARTBEATS PREMATURE - a type of arrhythmia. It is a beat that occurs earlier than expected, briefly interrupting the normal heart rhythm. PACEMAKER GENERATED ARRHYTHMIA - An electrocardiographic finding in which a variation in heartbeat is due to an artificial cardiac pacemaker.
The definition doesn't really differentiate between them II
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Change NCI PT from 'Georgia' to 'Georgia (Republic)' I
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In the line about calcium, I can see "Eosinophil to Leukocyte Ratio" as the NCI Preferred Term. I think it must be "Calcium Measurement".
The UNIT codelist does not provide values for the collection and tabulation of the number of certain products like cigars, cigarettes, pipes, etc. smoked. Please either add these units to the codelist or provide guidance for the collection and tabulation of the number of a certain substance consumed.
A person's optimum weight as defined by the Metropolitan Life Tables which include a combination of factors for height, age, frame size, and gender.
A person's optimum weight as defined by the Metropolitan Life Tables which include a combination of factors for height, age, frame size, and gender.
Add the unit of mm (millimeter) to the Vital Signs Result Unit codelist. This unit is used in the measurement of newborns.
Please add the term C Reactive Protein, High Sensitivity to the Laboratory Test Name codelist with the corresponding test code of CRPHS.
In C96679, C96680, C74661, C74911, C74619, PLS is being used to represent plasma cells. PLSIxxxx for immature plasma cells, PLSMxxxx for Mature Plasma cells. Please reconsider the code for C98869 from PLSMCECE to PLSCECE otherwise how will you create a code for Mature Plasma Cells/Total Cells
Please add the unit cells/nL to the Unit codelist. Definition: A unit of cell concentration expressed in cells per unit of volume equal to one nanoliter.This unit is associated with results in the WBC differential tests.
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Please add 10^6/mm3 as a synonym to the submission value of 10^12/L.
um3 has the synonym of cubic micrometer.
1 cubic micrometer = 1 femtoliterThe definition of femtoliter states that it is a unit of volume equal to 10E-15 liter while the definition for cubic micrometer states that it is a unit of volume equal to 10E-18 liter. The definition for cubic micrometer should be a unit of volume equal to 10E-18 liter cubic meter ? which is equivalent to 10E-15L.
A semi quantitative analysis of bilirubin in urine is not a measurement of the total bilirubin. A change is needed to C38037. Request to Change to C38037 to ?Total Bilirubin? and keep definition as ?A measurement of the total bilirubin in a biological specimen.?Change LBTESTCD to BILITOT. Add new LBTEST = called ?Semi Quantitative Bilirubin? or just ?Bilirubin? with a definition of ?A semi quantitative measurement of the bilirubin in a biological specimen.? Corresponding new LBTESTCD = BILISEMI
For C64431 Albumin, remove ?Microalbumin? as a synonym. Add new LBTEST = Microalbumin with a definition of ?A measurement of the microalbumin in a biological specimen.?Corresponding new LBTESTCD = MICROALB. Add new LBTEST = Segmented Leukocytes with a definition of ?A measurement of thesegmented leukocytes in a biological specimen.? Corresponding new LBTESTCD = WBCSG
For FREQ, codes C64526 and C67069, appear synonymous. The definitions do not explain the difference between 1 time per week and every week.
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Used for Microarray data III
The TBI Standards project has requested this questionnaire for implementation. It is in the public domain. I have sent the draft spreadsheet, CRF, the public domain verification document and the URL reference.
The Microscopic Domain was released in SDTM 3.2. This request is to setup the MITESTCD/MITEST terminology based on the examples in the domain document. I will send the New Terminology request spreadsheet to E. Muhlbradt & B. Yost.
The current terms available (C64831 and C82045)are a percentage to the leukocytes. The test code and test we are requesting to add for segmented neutrophils is for segmented neutrophils as a percentage of neutrophils counted (segmented and non segmented) not as a percentage of leucocytes so if it tied to leucocytes in any way (similar for the nonsegmented percentage).
Request to add the following:LBTESTCD = NEUTSGNELBTEST = Neutrophils, Segmented/NeutrophilsDefinition = A relative measurement (ratio or percentage) of segmented neutrophils to neutrophils counted (segmented and band form) in a biological specimen.
LBTESTCD = NEUTBNELBTEST = Neutrophils Band Form/ NeutrophilsDefinition = A relative measurement (ratio or percentage) of band form neutrophils to neutrophils counted (segmented and band form) in a biological specimen.
Suggested definition:A benign neoplasm in the superficial dermis with direct association to the epidermis,composed of well differentiated squamous epithelium and a central cavity filled with concentric layers of keratin; a pore (opening in the epidermis) may be present.
suggested definition:A malignant neoplasm of hematopoietic or lymphoreticular cells.
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The LBTESTCD PROT refers to Protein. The NCI Preferred Tem is Total Protein Measurement. The physicians would like to clarify in CT that this is Total Protein - or that a new test be added for Total Protein. They want it to be clear to the sites. Even adding a synonym of Total Protein would help.The LBTESTCD Bili refers to Bilirubin. The NCI Preferred Term is Total Bilirubin Measurement and the synonym is Total Bilirubin. The definition denotes total bilirubin. The physicians would like to use the synonym rather than the submission value to be clear that this is a total bilirubin measurement. Is this acceptable - as long as the submission value in SDTM is Bilirubin? Can the LBTEST value be updated to state Total Bilirubin?
Definition = biologic activity of factor VIII inhibitor (source = UCUM)
Definition = IgG, biologic activity of anticardiolipin (source = UCUM) per milliliter
Definition = IgM, biologic activity of anticardiolipin(source = UCUM) per milliliter
the cells are described in the test value, so you do not need cells in the unit code.
All entries currently in QS Terminology (except for Questionnaire Category) should have "QS-" at the beginning of each row in the Codelist Name column. This is to distinguish the rows from "FT-" for functional tests.
Change all rows in the Codelist name column to "Category of Questionnaire".
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Biopsy - here are many different types of biopsy procedures. The most common types include: (1) incisional biopsy, in which only a sample of tissue is removed; (2) excisional biopsy, in which an entire lump or suspicious area is removed; and (3) needle biopsy, in which a sample of tissue or fluid is removed with a needle. When a wide needle is used, the procedure is called a core biopsy. When a thin needle is used, the procedure is called a fine-needle aspiration biopsy. (From the NCI website)Aspiration - Removal of fluid or tissue through a needle (from NCI website)
Multi Gated Acquisition Scan designed to evaluate the function of the right and left ventricles of the heart
File emailed separately. These terms were requested and approved, for the Species code list, by the CT Virology team.
CV ENDPOINTS Standards project request. I sent the multiple term request spreadsheet to B, Yost & E. Muhlbradt
File emailed separately - The proposed terminology, copyright verification page, and pdf of questionnaire will be sent via email.
Change definition to: Examination of a biological specimen to detect the presence of yeast cells in a biological specimen.
PRESENT and ABSENT are qualitative results for RBC Morphology tests such as Acanthocytes, Basophilic Stippling, etc.
File emailed separately. Please find attached a request for 2 new ADaM codelists Analysis Reason and Analysis Purpose required for analysis results metadata that I submit on behalf of the CDISC ADaM metadata sub-team. Both codelists should be extensible. The suggested terms for the codelist Analysis Purpose are a subset of values from the SDTM Trial Summary Parameter Test Name Codelist (C67152).
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Cup Unit of volume III
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Immunofluorescence is a powerful technique that utilizes fluorescent-labeled antibodies to detect specific target antigens.
The TBI standards project requested the Mayo-Portland Adaptability Inventory (MPAI-4)questionnaire for implementation. I am sending draft QS terminology spreadsheet, the public domain verification document and the CRF via e-mail.
There has been discussion in the past about deprecating this subset (which includes just one codelist of the same name) as the terminology is not linked to any existing CDISC domain standards.
The Virology CT team requested disease specific bacteria species from Jordan (NCI). See attached list from Jordan.
As flow cytometry costs have dropped and the demand for personalized medicine has risen, flow cytometry-based biomarker testing is becoming more common. My previous and current employers have both struggled to standardize this data as the internal test codes from the various laboratories differ and, at times, it can be challenging to determine if similar looking test codes from different laboratories are actually the same. Is the CDISC CT Team looking at this space or have plans to do so?
DNA Microarray was recently added to the Method codelist and the Virology team felt that it is necessary to update the Microarray definition.
File emailed separately. The TBI standards project requested the Extended Glasgow Outcome Scale (GOSE) questionnaire for implementation. I have submitted the request in the NCI/EVS system to be tracked.
Missing in the latest QS Terminology III
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Request the addition of the test name Varicella Zoster Virus DNA to the laboratory test name codelist with the test code VZVDNA. Proposed definition: A measurement of varicella zoster virus DNA in a biological specimen.
ENDARTERECTOMY (NCI Code C52002) Definition: Excision of an atheromatous plaque.
CARDIAC STENT PLACEMENT (NCI Code C100080) Definition: A procedure performed during a percutaneous coronary intervention in which a device is deployed into the lumen of a coronary artery to expand and support the vessel wall such that the vessel remains patent and blood flow is uninhibited.
Per picoliter. A volume unit equal to one picoliter used as a denominator to build a derived unit expressed as a ratio.
Millimole per mole Hemoglobin. A unit of substance concentration defined as the concentration of millimoles of solute per mole of hemoglobin.
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I am part of the CDISC Hepatitis C TAUG group. Attached please find the request for controlled terminology for the Hepatic Encephalopathy test for CDISC Hep-C TAUG.
A measurement of the antimitochondrial antibodies subtype 2 in a biological specimen. To be used with LBTESTCD AMA2AB
A measurement of the anti-neutrophil cytoplasmic antibody in a biological specimen. To be used with LBTESTCD ANCAB.
A measurement of the bactericidal/permeability-increasing protein antibody in a biological specimen. To be used with LBTESTCD BPIPAB
A measurement of the cathepsin antibody in a biological specimen. To be used with LBTESTCD CATHPSAB
A measurement of the granulocyte elastase antibody in autoimmune diagnostics in a biological specimen. To be used with LBTESTCD ELAAB
A measurement of the inactivated factor II in a biological specimen. To be used with LBTESTCD FACT2IAT
A measurement of the lactoferrin antibody in a biological specimen To be used with LBTESTCD LTFAB
A measurement of lysozyme in a biological specimen. To be used with LBTESTCD LYSOZYM
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A measurement of the nucleosome antibody in a biological specimen. To be used with LBTESTCD NUCSLMAB
A measurement of the proliferating cell nuclear antigen in a biological specimen. To be used with LBTESTCD PCNAG
A measurement of the polymyositis -Scl antibody in a biological specimen To be used with LBTESTCD PMSCLAB
A measurement of the proteinase 3 antibody in a biological specimen. To be used with LBTESTCD PRN3AB
A measurement of the ribosomal P-protein antibody in a biological specimen. To be used with LBTESTCD RIBSPAB
A measurement of the ribonucleoprotein 70 antibody in a biological specimen. To be used with LBTESTCD RNP70AB
A measurement of the ribonucleoprotein - Smith complex antibody in a biological specimen. To be used with the LBTESTCD RNPSMAB
A measurement of the Sjogrens SS-A52 antibody in a biological specimen. To be used with LBTESTCD SJSA52AB
A measurement of the Sjogrens SS-A60 antibody in a biological specimen. To be used with LBTESTCD SJSA60AB
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This term is part of the E2B units of measure terminology and CDISC has not published it yet. It is needed for the CDASH SAE standard. E2B Synonym of iu(1,000,000s)
CDISC is publishing the term ANGIOGRAM with the correct definition but we coded it to the concept of Lymphangiogram in error (Angiogram deals with blood vessels, Lymphangiogram deals with the lymphatic system). The c-code for the current concept C16805 will be changing to C16290. The NCI PT will be updated to Angiogram.
Radial immunodiffusion is an immunodiffusion technique used in immunology to determine the quantity of an antigen by measuring the diameters of circles of precipitin complexes surrounding samples of the antigen that mark the boundary between the antigen and an antibody suspended in a medium, such as an agar gel.
Since X-Ray is a specific type of modality used in angiograms (others can be used like MRI), please update the CDISC definition of ANGIOGRAM to something like: An image of blood vessels made after the injection of a radiopaque substance. This was brought up as part of CV therapeutic area terminology review.
From Ron Fitzmartin: Clearly E3 Q&A document that you reference below implies that “violation” should be replaced with “deviation”. E6 is makes it clear that the term is, in fact “deviation” (except in the appendix where it has a reference to “violation”). Then we have E9 which implies, by its use of both protocol “deviation” and “violation”, that there is a clear difference between the two terms and provides some examples. I agree with E3 Q&A document that some use the terms interchangeably, but, personally, I have not. Perhaps it should be discussed a bit further.
This term is greater than 40 characters. Per CDISC SDTMIG, EGTEST (like all --TEST variables) is required to be 40 characters or less
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CTC 4.0.3 grades for lab values, Hypocalcemia and hypercalcemia, would be arrived at using this lab result. For instance, a serum calcium of 10.4 mg/dL is normal, yet an albumin of 3.6 results in a corrected calcium of 11.2, which is CTC grade 1.
A request for EGTEST = "ECG Abnormality" was made by Erin Muhlbradt in March of 2011 per the change request tracker, but I can't find the final decision for this. Some results may not be abnormal, so a "Finding" would be a better fit. It appears that the terminology team expects the users to assign an appropriate EGTEST value for each type of finding/issue, but the current set of EGTEST values make this challenging. At a minimum, the team should ensure there is at leaset one appropriate EGTEST value for each result. Guidance for assigning values in a consistent manner could also help.
Please add the term dpm/0.5 mL to the Unit codelist with the synonym of disintegrations per half a milliliter. This is used as a unit for radioactivity on a study medication form.
"Requesting 4 new questionnaires be added to the SDTM QS Terminology spreadsheet: -EORTC Quality of Life Questionnaire C30 (EORTC QLQ-C30) -EORTC Quality of Life Questionnaire LC13 (EORTC QLQ-LC13) -EORTC Quality of Life Questionnaire STO22 (EORTC QLQ-STO22) -EORTC Quality of Life Questionnaire H&N35 (EORTC QLQ-H&N35)"
For the newly created SDTM-MITEST/CD codelists (not yet available on the drop-down list, please consider the addition of the following: Estrogen Receptor is a protein that is found inside cells. It is a receptor that is activated by the hormone estrogen. To be used with MITESTCD = ER; MITEST = Estrogen Receptor
For the newly created SDTM-MITEST codelist (not yet available on the drop-down list), please consider the addition of the following: Human Epidermal Growth Factor Receptor 2: is a member of the epidermal growth factor receptor (EGFR/ERBB) family. To be used with MITESTCD = HER2; MITEST = Human Epidermal Growth Factor Receptor 2
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For the newly created SDTM-MITEST codelist (not yet available on the drop-down list), please consider the addition of the following: Ki-67 : is a protein that in humans is encoded by the MKI67 gene. Antigen KI-67 is a nuclear protein that is associated with and may be necessary for cellular proliferation. Furthermore it is associated with ribosomal RNA transcription. Inactivation of antigen KI-67 leads to inhibition of ribosomal RNA synthesis. To be used with MITESTCD = KI-67; MITEST = Ki-67
For the newly created SDTM-MITEST codelist (not yet available on the drop-down list), please consider the addition of the following: Progesterone Receptor is a protein that is found inside cells. It is a receptor that is activated by the hormone progesterone. To be used with MITESTCD = PGR; MITEST = Progesterone Receptor
File emailed separately; QS-HADS TEST and QS-HADS TESTCD, need variables for subtotals, found in author's documentation and printed versions.
The definition for REGID says "Identification numbers assigned to the protocol by ct.gov, EudraCT, or other registries." "ct.gov" is the official website for the State of Connecticut (try it); it isn't relevant. The correct website reference is "clinicaltrials.gov". The 2 are not interchangeable.
C98714
HBVVLD (C92542) and HBDNA (C103404) I think are used synonymously. HBVVLD measures the amount of Hep B DNA in a specimen and I am not sure how HBDNA differs as this is also a measure of HBDNA. It is true that HBVVLD suggest an absolute measurement and HBDNA suggests a qualitative measurement, but we should not be creating different test codes for quantitative vs qualitative). I would suggest HBDNA is retired as a term and that a synonym is added to HBVVLD of Hepatitis B DNA (this is similar to what we did with Hep C where Hepatitis C RNA is a synonym for Hepatisis Viral Load
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Requesting the addition of a general term to capture the Urine Color, Appearance and Dipstick results as Normal instead of entering a result of normal for each test. The same idea as the existing term of Sediment Examination - used for microscopic examination. Draft Definition: An observation, assessment or examination of the physical properties and chemical properties (ie. dipstick tests) in a urine specimen.
Requesting the addition of the units: umol/dL; IU/dL; umol/L/min which are used for the measurement of Chemistry tests.
The submission value for C62954 and C112361 needs to be in upper-case.
The Category Name should be updated to include the timepoint of (24H) as we have been given permission by the copyright owner to also collect (7D) for the BPI Short Form. Other timepoints could be requested in the future so the category name should reflect this as the timepoint is included in the questions as well as a few of the TEST NAMES.
The Dual Energy X-Ray Absorptiometry (DXA) test ""Lean Body Mess Femur Ratio"" is with regards to a weight divided by the length. Normally, we get the LBM in kg and the femur length in cm. Therefore, the LBM / femur length ratios are calculated in kg/cm. Concerning this ratio, it was proposed by Ronenn in a previous BYM338 study and it has been included in all TM studies with BYM. The normalization is often done as skeletal mass index (SMI: total lean body mass per height square) or appendicular skeletal mass index (ASMI: appendicular LBM per height square). Sometimes femur length is used as surrogate measure of patient size for additional normalization.
The Actibelt test "Mean mediolateral body sway test" traces acceleration in 3D with reference to G (gravitation), hence the unit is m/sec2. This is a direct output from the device.
For the orthopedic indication for hip fracture study, Exercise Adherence Diary data is collected for each of the exercise/therapy sessions. Each exercise session consists of "Hip range of motion exercises" and "Strengthening exercises", which includes the Knee extension test.
Also multiple new term requests for SDTM-LOC, please see attached file.
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An option is needed at a Washout EPOCH which is directly followed by a Run In Phase, to allow sites to indicate when a Subject has not met Protocol defined Blood Pressure criteria.The option """"Failure to meet randomization criteria"""" is not generic enough to cover an EPOCH/Phase which occur before Randomization, but not directly before it. For example """"Failure to meet randomization criteria"""" is not appropriate to use on a Washout Disposition page in a trial design where there is a Screening Phase, then a Washout phase and then a Run In phase prior to Randomization. When Novartis originally requested the option of """"Failure to meet randomization criteria"""" this situation was not considered. Therefore a more generic term is now being requested which would be usable at any visit where there is defined criteria which must be met in order for a Subject to continue into the next EPOCH/Phase.
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C84507&ns=NCI_Thesaurus
Specimen type is relevant to Biogen analyses of certain virus antibodies. The buffy coat is one of the specimens in which Biogen tests for certain antibodies. Please note the NCI Thesaurus reference.
Need to differentiate methods of HCV testing.
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C95525&ns=NCI_Thesaurus
Please make the SEND OMTEST and OMTESTCD codelists extensible [Change Property from No to Yes] The SEND team has already agreed to this change and will expect this change to go out with P19 public review.
SEND wants to re-use some concepts from the SDTM-LOC codelist for the SEND-SPEC codelist. The definitions as published now are too human-centric.
File emailed separately
SEND team agreed to add COTTON RAT with Definition: The rat of the genus and species Sigmodon hispidus.
SEND team has agreed to proposed updates to the STRAIN codelist. File emailed separately.
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Addition of 3 new codelists and associated terms for SEND MI variables including NONNEO, CHRNCTY, DSTRBN. SEND team has developed and finalized these terms and they will go out for P19 public review.
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Addition of 4 new codelists and associated terms for SEND safety pharm work including SCVTST, SCVTSTCD, SRETST, SRETSTCD. SEND team has developed and finalized these terms and they will go out for P19 public review.
File emailed separately
An inorganic anion of fluorine with the chemical formula F? It contributes no color to fluoride salts. Fluoride is the main component of fluorite (apart from calcium ions; fluorite is roughly 49% fluoride by mass), and contributes a distinctive bitter taste, but no odor to fluoride salts. Its salts are mainly mined as a precursor to hydrogen fluoride. As it is classified as a weak base, concentrated fluoride solutions will cause skin irritation.
This was discussed at the SEND F2F. This is in response to a public review comment for P18.
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I?m looking at the existing LBTESTCD/LBTEST terms for Viral tests and need some clarification. Based on the 28th March release, there are the terms that exist related to RNA, DNA and viral load tests. Can you tell me what the current convention for naming these tests? It looks like things have changed over time. HCVVLD has a synonym of HCV RNA. But Hepatitis G has a submission value of ?Hepatitis G RNA?, not ?Hepatitis Viral Load?.
Hepatitis B has a test for ?HBV Viral Load? and one for ?Hepatitis B DNA?. Our virology expert at GSK has said that DNA is a measure of Viral Load, so which one should I choose? She also said that both DNA and RNA can be classified as ?Viral Load?, but that by converting them to that term, we are losing a bit of information ? the fact that it was the RNA or DNA. Should we have specific tests (either RNA or DNA since they cannot have both) for ALL the viral tests and retire the ?---VLD? LBTESTCD terms and ?.....Viral Load? LBTEST terms? Or should the term ?Viral Load? be retained and the RNA/DNA synonym added? Either way I think we need to be consistent across the board.
I am also querying the use of Acronyms ? HBV versus Hepatitis B for example. Can we be consistent and go back and change these? This is critical for us because we have a large group of viral tests which are not currently in the SDTM terminology list and we cannot wait for the next release ? I need to finalise them now. I?m just not sure how to name the LBTESTCD or LBTEST to be consistent with the CDISC SDTM standard. Do I call them all Viral Load, or use the DNA/RNA naming convention? Adenovirus DNA PCR Epstein-Barr virus DNA PCR Hepatitis E Virus RNA PCR Hepatitis E RNA PCR Human herpesvirus 6 DNA PCR Herpes Simplex Virus 1 /2 DNA PCR SEND Repro team would like to include the following terms in the new codelist FXSTRESC for fetal findings terminology.
File emailed separately.
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Muscle, Plantaris: One of three superficial muscles at the back of the leg, between the soleus and the gastrocnemius. Assists in flexing the foot and knee.
Muscle, Extensor Digitorum Longus: Muscle located on the lateral part of the rear leg. Its actions involve the extension of the digits and dorsiflexion of the foot.
Brain, Visual Cortex: A brain region in the occipital cortex that receives visual stimuli from the retina.
Brain, Optic Chiasm/Tract: The nerves that travel from the place in the brain where some of the optic nerve fibers cross into certain parts of the brain involved in vision.
Pleura, Parietal: The outermost of the two pleural membranes, lines the wall of the pleural cavity.
Pleura, Visceral:The innermost of the two pleural membranes, lines the surface of the lungs in the pleural cavity.
Duodenal Papilla, Minor: The opening of the accessory pancreatic duct into the duodenum, located anterior to and slightly superior to the major papilla.
Duodenal Papilla, Major: The opening of the commmon bile duct and pancreatic duct into the duodenum.
Duct, Pancreatic: The major pancreatic duct joining the pancreas to the common bile duct
Duct, Common Bile: The duct formed by the union of the common hepatic duct and the cystic duct
Duct, Common Hepatic: The duct formed by the union of the right and left hepatic ducts. Requesting to separate the treated and untreated SPECs below. There isn't an alternative place to indicate ""treated"" or ""untreated"" because it isn't an anatomical region.
Treated Skin: A treated organ that constitutes the external surface of the body. It consists of the epidermis, dermis, and skin appendages.
Untreated Skin: An untreated organ that constitutes the external surface of the body. It consists of the epidermis, dermis, and skin appendages.
Treated SKIN/SUBCUTIS: A treated tissue sample that contains the epidermis, dermis, and subcutaneous adipose tissue.
Untreated Skin/subcutis: An untreated tissue sample that contains the epidermis, dermis, and subcutaneous adipose tissue.
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New terms proposed for the SDTM LOC codelist. III
New terms proposed for the SDTM UNIT codelist. III
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Team decides to remove this from existing terminology. II
Use when LBTEST=ETHANOL III
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CDISC Definition: Named, stand-alone task-based evaluations designed to provide an assessment of mobility, dexterity, or cognitive ability.
CDISC Definition: Captures the agents administered to the subject as part of a procedure or assessment as opposed to drugs, medications and, therapies administered with therapeutic intent.
A measurement of the proportion of oxygen contained in the inspired air.
A relative measurement (ratio or percentage) of the force per unit area (pressure) of oxygen dissolved in arterial blood to the percentage oxygen of an inhaled mixture of gasses.
A measurement of the percentage of hemoglobin in the arterial blood which is bound with oxygen.
SHORT PHYSICAL PERFORMANCE BATTERY is a standard test to measure the mobility disability. Points is the unit from SHORT PHYSICAL PERFORMANCE BATTERY score calculation.
When whole assessment is not performed,the data will be collected on a single record. The parameter name will be 'EGALL', Status should be 'NOT DONE' and REASON should be provided
Proposed definition is "A relative measurement (ratio or percentage) of the Type II Collagen C-Telopeptides to the creatinine in a biological specimen."
These terms are part of two new questionnaires being developed for traumatic brain injury, GOSE and MPAI. They are the evaluator choices given on the CRFs. Interviewer is on GOSE whereas the others are all options on the MPAI.
Add 3 new terms to LBTEST/CD and UNIT codelists. Please see attached spreadsheet in separate email.
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INHAND talks about them as a single entity "preputial/clitoral gland". They are currently separate SPEC terms in CDISC. Biologically it is the same gland in both males and females - the name is just different in the different sexes. Some sites use one term to make things simpler, so we only need one list of findings rather than replicating the findings in two separate tissues.
Does not conform to STDM nomenclature. Should read: DEVICE OPERATIONAL ISSUE NON-STUDY EQUIPMENT ISSUE
Request content is modeled after the content of the CDISC term for Interleukin 1 Beta. Definition of new term: A measurement of interleukin 1 alpha in a biological specimen.
BPI SHORT FORM is currently the QSCAT but the developer of the questionnaire has allowed Merck to use the 24 Hour version that you have posted and a 7 Day version. We ask that the QSCAT be updated to read as: BPI SHORT FORM (24H)since the timepoint is inbedded within the test name and the questions. Merck will be submitting a request to add BPI SHORT FORM (7D) as another option.
Add terms to LBTEST/CD
File emailed separately
Should Transposon be updated to all upper case (TRANSPOSON) to be consistent with the other terms in codelist (e.g.RIBOZYME)
TSPARM-CD. Multiple new term requests for Trial Summary Parameter Test Codes and Test Names. QT Studies TA team request. This information is requested by the FDA for TQT studies as part of the FDA Study Level Specification. File emailed separately.
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Please add the test name MELD Score with the test code MELDSCR to the laboratory test name codelist. The MELD (Model for End-Stage Liver Disease) Score is a numerical scale used for liver allocation. The MELD score is based on a patient's risk of dying while waiting for a liver transplant, and are based on objective and verifiable medical data. The MELD Score is calculated using Creatinine, Bilirubin and INR results. The MELD formula is: MELD Score = (0.957 * ln(Serum Cr) + 0.378 * ln(Serum Bilirubin) + 1.120 * ln(INR) + 0.643 ) * 10 (if hemodialysis, value for Creatinine is automatically set to 4.0) This looks like a similiar concept as the existing term of FibroTest Score that uses the value of lab tests to calculate a score.
Currently a term or synonym is not available for mapping. The suggested definition would be "A unit of substance concentration defined as the number of micrograms of a substance per millimole of substance". This unit was used for LBTEST= Type II Collagen C-Telopeptides/Creatinine.
New Terms add to the SDTM-UNIT and Route of Administration Codelists; File emailed separately
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Lab data often describe relationships to numeric reference values with terms which are more descriptive that simply 'LOW', 'HIGH', or 'NORMAL'. Conforming to current controlled terminology requires mapping both 'LOW PANIC' and 'LOW NORMAL' to 'LOW' and both 'HIGH PANIC' and 'HIGH NORMAL' to 'HIGH'. This results in a loss of information or the need to include additional information in a supplemental qualifier.
Draft Definition for 'LOW PANIC': Reported value below a critical value indicating the result may be medically important
Draft Definition for 'LOW NORMAL': Reported value below the typical range but above a critical value indicating the result may be medically important
Draft Definition for 'HIGH PANIC': Reported value above a critical value indicating the result may be medically important
Draft Definition for 'HIGH NORMAL': Reported value above the typical range but below a critical value indicating the result may be medically important
New QS Codelist = BPI Short Form (7D)
File emailed separately
The General Terminology Team decided to remove ANGIOGRAM (C16805) from the Method codelist. And they want to add ANGIOGRAPHY.
Add terms to C-SSRS Children's Baseline; File emailed separately
Add terms to C-SSRS Children's Baseline/Screening; File emailed separately
Add terms to C-SSRS Children's Since Last Visit; File emailed separately
Add terms to C-SSRS Screening; File emailed separately
Add terms to FAQ; File emailed separately. III
Add terms to FAQ-NACC; File emailed separately III
Add terms to MRS; File emailed separately III
Add terms to SDS; File emailed separately III
Add terms to AQ20; File emailed separately III
Add term to QS-DS; File emailed separately III
Add term to QS-EDSS; File emailed separately III
Add terms to FAMS; File emailed separately III
Add terms to KFSS; File emailed separately III
Add terms to MHIS-NACC; File emailed separately III
Add term to QS-PDDS; File emailed separately III
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Add terms to QS-SGRQ Past 3 months Add terms to QS-SGRQ Past 4 weeks; File emailed separately
Add new terms to VFQ24-IA; File emailed separately
Add new terms to VFQ25-SA; File emailed separately
Add terms to QS-BLCS; File emailed separately
Add terms to QS-BORG CR-10 Scale; File emailed separately
Add terms to QS-BWCS; File emailed separately
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Add terms to QS-MFIS; File emailed separately III
Add terms to QS-MSQOL-54; File emailed separately III
Add terms to RAND-36 V1.0; File emailed separately III
Add terms to FT-CAT SIXMW; File emailed separately III
Add terms to QS-DRS; File emailed separately III
Add terms to QS-GOSE; File emailed separately III
Add new terms to FTCAT QS-HAI; File emailed separately III
Add terms to QS-MPAI; File emailed separately III
Add terms to FTCAT QS-NHPT; File emailed separately III
Add terms to FTCAT QS-PASAT; File emailed separately III
Add term to FTCAT QS-SDMT; File emailed separately III
Add new terms to QS-SWLS; File emailed separately III
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Add term to FTCAT QS-TUG; File emailed separately III
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Add terms to QS-C-SSRS Pediatrc/Cognitively Impaired Lifetime/Recent; File emailed separately
Add terms to QS-EQ-5D-3L; File emailed separately
Add terms to QS-EQ-5D-5L; File emailed separately
Add terms to QS-FSS; File emailed separately
Add terms to QS-IVIS; File emailed separately
Add terms to FTCAT QS-T25FW; File emailed separately
Change submission term for the unit concept uIU/mL to mIU/L since the latter is SI compliant and the former is not.
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Aerosol Administration through a mask. III
Aerosol Administration through a whole-body chamber. III
Add new terms to the Unit Codelist; File emailed separately. III
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DLQI to be added to QS Domain; File emailed separately. III
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Please add this specific arbitrary unit is support of Complement Hemolytic CH50. Please consider adding both CH50 unit and CH50 unit/mL.
File emailed separately; Questionnaires can be completed by a subject's proxy, as with the EQ5D.
nmol/day is supported in PK units but not the general unit codelist. Can it please be added.
C84507 BUFFY COAT Current Definition: The upper clear layer of fluid which is separated from a blood clot following density gradient centrifugation. It contains most of the white blood cells. (NCI) Can the definition be changed to : The upper clear layer of fluid middle fraction which is when separated from an anticoagulated blood clot specimen following density gradient centrifugation. It contains most of the white blood cells and platelets.
The LAB Terminology Team is asking if the definition could be changed to: The upper clear layer of fluid middle fraction which is when separated from an anticoagulated blood clot specimen following density gradient centrifugation. It contains most of the white blood cells and platelets.
EORTC QLQ-MY20 to be added to QS Domain terminology; File emailed separately.
Asthma Control Diary (ACD) to be added to QS Domain terminology; File emailed separately.
SF-36 V2 Acute to be added to QS Domain terminology; File emailed separately.
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FACT-Bl to be added to QS Domain; File emailed separately III
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New QSCAT and Codelist for CHART-SF questionnaire used in traumatic brain injury assessment. Can the QS team also help with accessing the original article reference for this questionnaire?
C48475 Submission Value currently is BAR (A dosing measurement based on the bar unit.). The lab terminology team would like to change the submission value to DBAR. BAR is for the BAR Unit of Pressure, which is currently being added as a new unit code. This request is from the lab terminology team.
FACT-B: For patients with Breast cancer to be added to QS Domain terminology; File emailed separately
Request FACT-G to be added to QS Domain; File emailed separately
Request NCCN-FACT FBSI-16 to be added to QS Domain; File emailed separately
Request FACT-Taxane to be added to QS Domain; File emailed separately
New synonym for existing term "Smooth Muscle Antibody". Add "F-Actin Antibody"
Add new terms to LBTESTCD and LBTEST; File emailed separately.
New test and test codes for the Respiratory Test Codelists; File emailed separately.
CDISC and NCI definitions appear to be in error; this is not a concentration unit.
Existing Definition: Unit of arbitrary substance concentration (biologic activity concentration) defined as the concentration of one international unit per one milligram of substance.(NCI)
Correct definition: A unit of measure of quantity of substance per unit mass, expressed in terms of International Units per milligram. This request is from the PK Terminology Team.
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Add new CDISC SY to 'Smooth Muscle Antibody'. II
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Add 2 new TEST/CDs; File emailed separately. III
File emailed separately. Several definition updates for multiple C-SSRS questionnaires.
CYTOMEGALOVIRUS is a submission value and Human Cytomegalovirus is a synonym to the term HUMAN HERPESVIRUS 5.Is this a duplicate? Or does the submission value of CYTOMEGALOVIRUS represent Unclassified Cytomegalovirus?
Pseudocowpox Virus (C112401) has a SY that's all uppercase: PARAVACCINIA VIRUS. Change this to lowercase. Change implemented in P18.
please consider updating the LBTESTCD APP to reflect total Amyloid Precursor Protein. As the current version consider APP to be only Amyloid Precusor Protein Beta, to accomodate this change i suggest to add APPA (Amyloid Precusor Protein Alpha) and APPB (Amyloid Precusor Protein Beta) so that both amyloid precursors can be referenced.
so in short:
APP = Total Amyloid Precusor Protein APPA= Amyloid Precusor Protein Alpha APPB= Amyloid Precusor Protein Beta
Add new terms to LBTEST/CD codelist; file emailed separately.
Add new terms to MICROORG codelist; File emailed separately.
Now that we have upgraded COTTON RAT to a species, we need to include strains: Please include the following strains: hispidus, fulviventer
Add 4 new TEST/CDs; File emailed seperately.
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New Term Request = Disease Outcome: Virologic Failure, Sustained Virologic Response. File emailed seperately.
New Codelist Request = Transplant Outcome; and two new terms in this codelist: Success, Re-Transplant; File emailed separately.
I’ve attached a request to add three additional terms to the RACE code list: MULTIPLE, OTHER, UNKNOWN. The implementation guide for DM domain mentions these values in the assumptions and examples, and does a very good job of explaining how they should be used appropriately. The IG approach is more consistent with how subjects respond when asked about their race, and how the data is often collected. At any rate, the RACE code list and the implementation guide should be consistent with each other.
The term ENTEROBACTER TAYLORAE is a submission value as well as a synonym to ENTEROBACTER CANCEROGENUS.
The NCBI considers ENTEROBACTER TAYLORAE a synonym to the term ENTEROBACTER CANCEROGENUS, therefore the submission value of ENTEROBACTER TAYLORAE should be removed and it should remain as a synonym to ENTEROBACTER CANCEROGENUS.
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Add muscle, extensor digitorum longus. III
New LBTESTCD and LBTEST terms requested that currently aren't available.
LBTESTCD = CD161ALY, LBTEST = CD161a/Lymphocytes, Description = A relative measurement (ratio or percentage) of CD161a cells to all lymphocytes in a biological specimen LBTESTCD = CD45RALY, LBTEST = CD45RA/Lymphocytes, Description = A relative measurement (ratio or percentage) of CD45RA cells to all lymphocytes in a biological specimen. LBTESTCD = CD34LY, LBTEST = CD3/4/Lymphocytes, Description = A relative measurement (ratio or percentage) of CD3/4 expressing cells to all lymphocytes in a biological specimen. LBTESTCD = CD38LY, LBTEST = CD3/8/Lymphocytes, Description = A relative measurement (ratio or percentage) of CD3/8 expressing cells to all lymphocytes in a biological specimen. LBTESTCD = CD161LY, LBTEST = CD161/Lymphocytes, Description = A relative measurement (ratio or percentage) of CD161 cells to all lymphocytes in a biological specimen. LBTESTCD = CD45LY, LBTEST = CD45/Lymphocytes, Description = A relative measurement (ratio or percentage) of CD45 cells to all lymphocytes in a biological specimen.
Why is the controlled terminology called 'CVEXAMCD/CVEXAM' when it is attached to the CVTESTCD/CVTEST variables. That is inconsistent with all the other xxTESTCD/xxTEST codelists - the 3.3 IG refers to CVTESTCD/CVTEST CT not CVEXAMCD/CVEXAM.
This is for the influenza TA. Please add: RETEST = Peak nasal inspiratory flow; RETESTCD = PNIF
This request comes from the Lab Terminology Team. The lab rule is that if the test code/name has Creatinine or HGB in it then it does not need to be in the unit code.
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Suggested definition: Total number of animals purchased for the study, including replacement animals.
This Parameter code is suggested added as it is necessary regulatory information to certain regulatory authorities in Europe.
Education level and years of education; File e-mailed separately. The TBI team is submitting this request because the current EDLEVEL Subject Characteristic Test Code/Name has a conflicting synonym (Education Level) and definition (Years of education that a person has completed.). The name also implies that EDLEVEL is for a person's highest level of education completed, which matches the synonym, but not the definition.
We would like to change the definition of EDLEVEL to match it's name and synonym, or drop this variable and create a new one for education level as per the general terminology team's decision. The values for the new codelist would need to be developed by the general terminology team as this would affect many therapeutic areas.
We would also like to create a new Subject Characteristic Test Code/Name which contains the years of education that a person has completed.
Please remove NAG as a synonym from C103419. It already exists as a Submission Value for C79459 in the same codelist. This goes against our rule that we cannot have a synonym for one ccode be a submission value for a different ccode in the same codelist.
There is also another request from a different source that also complains about the NAG synonym.
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CVTESTCD: change CVEXAMCD (C101847) to CVTESTCD III
CVTEST: Change CVEXAM (C101846) to CVTEST III
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This request is for SEND-FXLOC (Fetal Pathology Examination Test Location) team. The CDISC definition for C12389, Esophagus, needs to be updated to remove the 25cm. This length of the esophagus is for adults. For animals and kids, the Esophagus is much shorter and different in length.
Here is the updated DEF from SEND: The portion of the digestive canal between the pharynx and stomach. It consists of three parts: the cervical part, from the cricoid cartilage to the thoracic inlet; thoracic part, from thoracic inlet to the diaphragm; and abdominal part, below the diaphragm to the cardiac opening of the stomach. (NCI)
Please see: http://en.wikipedia.org/wiki/Transthyretin Transthyretin is the current name for this test.Pre-albumin and Thyroxine-binding Pre-albumin should be synonyms.
If this proposal is not accepted please add TTR Transthyretin as a synonym of PREALB Prealbumin.
File emailed separately; CDISC_Multi_Term_Request_2014-07-03_Robert Dempsey
Please remove Ohm from the Vital Sign Units codelist.
New terms to be added to the SDTM-LOC codelist; File emailed separately.
Definition: A person actively involved in a specific study activity without having formal GLP responsibility. Example: Pathology peer review, TK evaluation in the absence of a formal TK delegated phase, or other non-GLP study activities.
Definition: focal lesions to the vessel wall due to the passage of the needle into the vessel at the injection site.
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Please add the following terms to the Specimen Type codelist: CORD BLOOD - Blood from the umbilical cord of a newborn baby. CORD SERUM - The clear portion of the blood that remains after the removal of the blood cells and the clotting proteins from the umbilical cord of a newborn baby. GASTRIC SECRETION - The digestive secretions of the gastric glands in the stomach, consisting mainly of pepsin, hydrochloric acid, rennin, and mucin. GASTRIC JUICE - synonym to GASTRIC SECRETION VAGINAL FLUID - a fluid produced by glands in the vaginal wall and cervix that drains from the opening of the vagina.
CDISC Submission Value capitalization change, should read "in".
The team feels that since there is a term of ""Other Event"" that this would cover what does not fit into the two other choices in the codelist: ""Disposition Event"" and ""Protocol Milestone"". The FDA has complained about the additional terms that have appeared in this codelist during a submission.
Should this codelist be NOT EXTENSIBLE? And also should there be additional terms like LOST or something else?
File emailed separately C-SSRS (QS-FT) Terminology definition updates.
The CDISC Definition for "Once" refers to an intervention (i.e. A one time intervention. (NCI)). This frequency could also apply to an Event. Note: The CDISC Notes for AEPATT (SDTM IG v3.2) state: "Used to indicate the pattern of the event over time. Examples: INTERMITTENT, CONTINUOUS, SINGLE EVENT.". For "single event", "ONCE" could be used as the controlled terminology. The BRIDG model includes the same 3 values for occurrencePatternCode associated with Adverse Events.
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Please add ICV and Intracranial Volume to MOTESTCD and MOTEST codelist respectively OR confirm the representation of Intracranial Volume in SDTM. Please add ICVNF and Intracranial Volume Normalization Factor to MOTESTCD and MOTEST codelist respectively OR confirm the representation of Intracranial Volume Normalization Factor in SDTM. Total intracranial volume may be included as part of structural MRI results. I have seen this referred to in the literature as ICV (http://web.mit.edu/daz/Public/O'Brien,%20Ziegler%20et%20al%20(2011)%20Psychiatry%20Res%20Neuroimaging.pdf) or TIV (http://www.ajnr.org/content/22/8/1483.full). In my opinion, ICV could be represented as a unique test code or using the existing MOTESTCD = VOLUME and MOLOC = SKULL.
As noted in the second article, ""variations in individual head size may be corrected by normalization with use of a total intracranial volume (TIV) measurement."" I have seen the ICV normalization value collected on multiple studies. In theory, this could be represented using a test code and location, but that seems cumbersome. Please advise.
Please add ASL FUNCTIONAL MRI or ARTERIAL SPIN LABELING FUNCTIONAL MRI to SDTM METHOD.
http://fmri.research.umich.edu/research/main_topics/asl.php http://fmri.ucsd.edu/UserTools/asl.html
Please add NA (as a representation for Not Applicable) to the EGLEAD codelist.
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Our vendors provide these codes all the time. II
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RETEST Multiple term request; File emailed separately III
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The CDISC Definition for AUCPEO is incorrect. It is currently the same value as AUCPBEO (back extrapolation). The definition should be "The area under the curve (AUC) from the last observed non-zero concentration value to infinity as a percentage of the area under the curve extrapolated to infinity." The same applies for the corresponding PKPARM code.
The definition should be "The area under the curve (AUC) from the last observed non-zero concentration value to infinity as a percentage of the area under the curve extrapolated to infinity." The same applies for the corresponding PKPARM code.
It will be beneficial to have terminology that uncouples the site and histology of neoplasms from each other, if for example analysis of Adenocarinomas from multiple anatomical sites are to be compared with Squamous cell carcinomas from multiple sites.
Add new terms to the Unit codelist; Sent a separate eMail to Bernice Yost and Erin Muhlbradt containing list of new unit terms requested.
Peak Nasal Inspiratory Flow is defined as: The maximal instantaneous airflow achieved during forced inspiration through the nose.
SEND team would like to replace the word 'chin' with 'mandible' in the definition so that this concept can be re-used for SEND purposes. Animals do not all have chins.
SEND team would like to change published definition to: 'The anterior or upper limb of an animal.' To make it less human-centric.
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Currently using these terms at Merck for a respiratory study. III
SEND team would like to update published definition to: 'The posterior or lower limb of an animal.' so that SEND can use this for animals that are quadrapedal.
Replace published definition with: 'A reproductive system organ that produces and releases either sperm (testis) or eggs (ovary). (NCI)'. Team didn't like the MeSH definition as much and would prefer to cite NCI.
To Erin: The FXLOC team likes the current NCI DEF rather than the NCI MeSH DEF which is published as the CDISC DEF for this term. FXLOC would like to update the CDISC DEF for this term, which is currently used by SEND-SPEC only, need SEND-SPEC approval.
There are multiple occurrences of this throughout various codelists. CT has terms that include umol/L, but really that's just the long way of saying "uM" (micromolar). 1mol/L=1M, 1 umol/L = 1 uM, and so on. At the very least, these should be added as synonyms (even if you don't want to change the submission value) as they are standard units throughout labs around the world.
This unit was used to measure Urine Protein/Creatinine. Suggested definition would be "A unit of substance concentration defined as the number of grams per millimole of creatinine.
New terms to be added to the UNIT Codelist; File emailed separately.
"Hepatitis G Virus" relates to a request for a seperate labtest under the review. "Hepatitis C Virus RNA"" HCVRNA This test detects active hepatitis C viral (HCV) replication (RNA). At Lilly we report in a Unit of 'International Unit per Milliliter' (313), a specimen type of 'Plasma'(PLS), and using the method 'PCR TAQMAN HCV/HPS 2.0'"
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File e-mailed separately, for a multiple term request. Thank you!
Hi Bob and Bernice, this term request was submitted on May 29 to add 226 'new terms' to multiple codelists. The actual submitted request file does not follow the format of the standard CDISC new term request template (in fact this person did not use the CDISC template posted on the NCI EVS site). Also, when I counted the # of new terms I noticed that the only relevant INFO provided by this request is the submission values of the new terms. There are NO use cases, examples or draft definitions for any of the proposed terms. Also from a quick glance I think a lot of the terms she requested are already in the published SDTM. I responded to the requester on May 29 asking whether she could provide more use case examples for the terms. I then followed up with her on June 25th to check if she is ready to re-submit the term request. She has not gotten back to me since then. This change request is now logged in this file. Bernice and Bob, perhaps you could get in touch with her again for the appropriate submission.
Remove Coronary Anatomy Dominance because it is not a synonym of Coronary Artery Dominance according to Dr. Tcheng.
Dr. Tcheng said that Coronary Anatomy Dominance is not a synonym for Coronary Artery Dominance.
We only need to have extra synonyms for PKPARMCD and PKPARM when we believe that it is absolutely necessary for the public to understand what the test is.
For Test Code/Test name or Long Name/Short Name or Parameters/Parameters Code codelists: there should only be one synonym if possible.
For Test Code/Test name or Long Name/Short Name or Parameters/Parameters Code codelists: there should only be one synonym if possible.
The requestor did not ask for this. It was added by the Device Terminology team. For Test Code/Test name or Long Name/Short Name or Parameters/Parameters Code codelists: there should only be one synonym if possible
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There are 2 synonyms: Sex of Participants and Sex Of Participants. The only difference is the upper case of the O in the word Of.
Either the testname should be changed to Body Fat or the test code should be changed to something like ADIPOSET. The synonyms are Adipose Tissue, Body Fat, Fat Tissue. For Test Code/Test name or Long Name/Short Name or Parameters/Parameters Code codelists: there should only be one synonym if possible.
The requestor did not ask for these synonyms, they were added by the Device Terminology Team. For Test Code/Test name or Long Name/Short Name or Parameters/Parameters Code codelists: there should only be one synonym if possible.
C12392 New Definition: A triangular-shaped organ located under the diaphragm in the right hypochondrium.
C12468 New Definition: One of a pair of viscera occupying the pulmonary cavities of the thorax, the organs of respiration in which aeration of the blood takes place.
C13272 New Definition: An organ present in true mammals during embryonic development that provides the fetus with nutrients and oxygen, facilitates gas and waste exchange between the fetus and mother.
C12782 New Definition: Any one of the paired bones extending from the thoracic vertebrae toward the median line on the ventral aspect of the trunk.
C12392 New Definition: A triangular-shaped organ located under the diaphragm in the right hypochondrium.
C12468 New Definition: One of a pair of viscera occupying the pulmonary cavities of the thorax, the organs of respiration in which aeration of the blood takes place.
C12782 New Definition: Any one of the paired bones extending from the thoracic vertebrae toward the median line on the ventral aspect of the trunk.
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ADENOMA, ADRENOCORTICAL , BENIGN and EPENDYMOMA, ANAPLASTIC , MALIGNANT. Remove the space after Adrenocortical and Anaplastic respectively.
This is a two item request. 1. The oncology team began discussing why the phrase 'by other methods or modalities' was added to the definition for these two terms when confirmation could be done using the same imaging modality as was done when the tumor was first identified. Team needs to revisit why this phrase was added to the definition initially. 2. Team needs to determine how to deal with update to codelist name in relation to New Tumor Confirmed value: either create a new concept 'New Tumor or Lesion Confirmed' and retire C103421 or keep C103421 and create a term New Lesion Confirmed.
Please add the term CARDIAC CATHETERIZATION to the Method codelist. This method is used for the measurement of Ejection Fraction (EF).Test used to measure EF include: echocardiogram, cardiac catherization, magnetic resonance imaging (MRI), computed tomography (CT), and nuclear medicine scans. (Reference: http://www.hrsonline.org/Patient-Resources/The-Normal-Heart/Ejection-Fraction#axzz38rpBW4fs) I wasn't sure if this should be a procedure or method but since there are other tests used to measure EF in the Method codelist, I am asking for the term to be added there.
Please add the term PDu with the synonym Progressive Disease Unconfirmed to the Tumor Result Response codelist.
This response criteria is used to support imaging results using PCWG2 (prostate cancer working group 2) criteria.
How should tests that are specific for one organism and are capturing only a absent/present result be captured? For example, a culture testing only for Cytomegalovirus and be reported as absent or present. A similiar secenario is capturing RNA replication for a specific organism. Discussed briefly in Virology Terminology meeting as possibly adding Species/strain field to LB domain.
Add new terms to the MICROORG Codelist; File emailed separately.
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OEFOCID; File emailed separately. III
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See attached HEP C TA new term request for Morphology and Microscopy test name and test code; File emailed separately.
definition - a condition presenting as a heart rhythm originating at or above the atrioventricular node.
The terms PDc (Progressive Disease Confirmed) and Non-PD are used for Prostate Oncology trials using PCGW2 criteria.
PDc: PD is a term that captures progressive disease per RECIST related to a new lesion, unequivocal progression of non target, or an increase in tumor burden of ?20% compared to nadir. The proposed work around solution was to use this existing term for PC-C per PCWG2, though they are not truly equivalent. Per PCWG2, PD-C or Progressive Disease-Confirmed implies that the patient has a previous timepoint of Progression as noted by at least one bone lesions by bone scan which was subsequently confirmed by the development of at least 2 additional bone lesions, per bone scan.
Non-PD: Non CR/Non PD is a term in RECIST that specifically refers to non target disease only with an overall response that is not response or progression. The proposed work around solution was to use this existing term for Non-PD term per PCWG2 , though they are not truly equivalent. Per PCWG2, non PD is the term that refers to a time point that follows a PD-Unconfirmed and this time point is not confirmed.
Please create new terms as follows: DSG1AB - Desmoglein 1 Antibody DSG3AB - Desmoglein 3 Antibody
The SDTM implementation guide requires that we place the name and version of the AE grading scale in the define XML (in a similar way that it asks that we put the coding dictionaries and versions in the define XML). For this reason it makes no sense to actually store the grading scales as controlled terminology, since they are governed by external controlled lists. Can this be explained. Will these be removed and if not, would you like me to submit values for other versions of CTC and also all version fo DAIDs, DMID etc?
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Definition: A physiologic assessment of platelet function that measures the amount of time required to achieve hemostasis following application of a small incision to a test subject?s skin.
A comparable term would also need to be added for VSTESTCD.
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Bazett's Correction formula (QTcB = QT/SqRootRR(seconds)) for beat 1. To be used with EGTESTCD=QTCB1
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Bazett's Correction formula (QTcB = QT/SqRootRR(seconds)) for beat 1. To be used with EGTEST=Bazett's Correction for beat 1
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Bazett's Correction formula (QTcB = QT/SqRootRR(seconds)) for beat 2. To be used with EGTESTCD=QTCB2
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Bazett's Correction formula (QTcB = QT/SqRootRR(seconds)) for beat 2. To be used with EGTEST=Bazett's Correction for beat 2
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Bazett's Correction formula (QTcB = QT/SqRootRR(seconds)) for beat 3. To be used with EGTESTCD=QTCB3
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Bazett's Correction formula for beat 3. To be used with EGTEST=Bazett's Correction for beat 3
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A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Bazett's Correction formula (QTcB = QT/SqRootRR(seconds)) for beat 4. To be used with EGTESTCD=QTCB4
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Bazett's Correction formula (QTcB = QT/SqRootRR(seconds)) for beat 4. To be used with EGTEST=Bazett's Correction for beat 4
The mean duration (time) of the QTc interval, obtained from a set of measurements of the QT interval and corrected using the Bazett's Correction formula (QTcB = QT/SqRootRR(seconds)). To be used with EGTESTCD=QTCBMEAN
The mean duration (time) of the QTc interval, obtained from a set of measurements of the QT interval and corrected using the Bazett's Correction formula (QTcB = QT/SqRootRR(seconds)). To be used with ECGTEST=Summary (MEAN) Bazett's Correction
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) for beat 1. To be used with EGTESTCD=QTCF1
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) for beat 1. To be used with EGTEST=Frederica's Correction for beat 1
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) for beat 2. To be used with EGTESTCD=QTCF2
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) for beat 2. To be used with EGTEST=Frederica's Correction for beat 2
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A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) for beat 3. To be used with EGTESTCD=QTCF3
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) for beat 3. To be used with EGTEST=Frederica's Correction for beat 3
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) for beat 4. To be used with EGTESTCD=QTCF4
A formula which takes into account the physiologic shortening of the QT interval which occurs as the heart rate increases, using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) for beat 4. To be used with EGTEST=Frederica's Correction for beat 4
The mean duration (time) of the QTc interval, obtained from a set of measurements of the QT interval and corrected using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) . To be used with EGTEST=QTCFMEAN
The mean duration (time) of the QTc interval, obtained from a set of measurements of the QT interval and corrected using the Frederica's Correction formula (QTcF=QT/CubeRootRR(seconds)) . To be used with EGTEST=Summary (MEAN) Frederica's Correction
The terms suggested in this request are modeled after the existing terms for Cardiolipin IgG Antibody and Cardiolipin IgM Antibody.
The sample is either fresh plasma or dried blood. The method is PCR (QUANTITATIVE REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION, I think).
The only test we see for this now is HIV Viral Load but this is not specific enough. We modeled this pair after these: HGRNA/Hepatitis G RNA.
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A person who has observed and/or interacted with the study subject and supplies information regarding their characteristics or behavior.
Updates to first 100 rows of SEND-SPEC terms to de-specify and remove functional information from published SEND definitions; File emailed separately.
Old DEF: An organ behind the lower part of the stomach that is the shape of a fish and about the size of a hand. It is a compound gland composed of both exocrine and endocrine tissues. The endocrine pancreas makes insulin so that the body can use glucose (sugar) for energy. The exocrine pancreas makes enzymes that help the body digest food. Spread all over the pancreas are areas called the Islets of Langerhans. The cells in these areas each have a special purpose. The alpha cells make glucagon, which raises the level of glucose in the blood; the beta cells make insulin; the delta cells make somatostatin. There are also PP cells and D1 cells, about which little is known. (NCI)
Change to: An organ located behind the lower portion of the stomach that contains both exocrine and endocrine tissue; the exocrine tissue produces enzymes that help digest food and the endocrine tissue produces insulin.
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Old DEF: An organ behind the lower part of the stomach that is the shape of a fish and about the size of a hand. It is a compound gland composed of both exocrine and endocrine tissues. The endocrine pancreas makes insulin so that the body can use glucose (sugar) for energy. The exocrine pancreas makes enzymes that help the body digest food. Spread all over the pancreas are areas called the Islets of Langerhans. The cells in these areas each have a special purpose. The alpha cells make glucagon, which raises the level of glucose in the blood; the beta cells make insulin; the delta cells make somatostatin. There are also PP cells and D1 cells, about which little is known. (NCI)
Change to: An organ located behind the lower portion of the stomach that contains both exocrine and endocrine tissue; the exocrine tissue produces enzymes that help digest food and the endocrine tissue produces insulin.
Old DEF: An artery arising from the right ventricle of the heart that carries deoxygenated blood to the lungs. (NCI)
Change to: Either one of two arteries arising from the pulmonary trunk that carry deoxygenated blood to the lungs.
Remove Bone, Cranial from CDISC SYs.
Old DEF: The section of the intestines between the pylorus and cecum. The small intestine is approximately 20 feet long and consists of the duodenum, the jejunum, and the ileum. Its main function is to absorb nutrients from food as the food is transported to the large intestine. (NCI)
Change to: The section of the intestines between the pylorus and cecum. The small intestine consists of the duodenum, the jejunum, and the ileum.
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Old Def: An organ located under the diaphragm, between the liver and the spleen as well as between the esophagus and the small intestine. The stomach is the primary organ of food digestion. (NCI)
Change to: An organ located under the diaphragm, between the liver and the spleen as well as between the esophagus and the small intestine.
Old Def: An artery located below the clavicle that supplies blood to the head and the arms forelimbs. The right subclavian artery originates from the innominate brachiocephalic artery and the left subclavian artery originates from the aortic arch. (NCI)
Change to: An artery located below the clavicle that supplies blood to the head and the forelimbs. The right subclavian artery originates from the innominate artery and the left subclavian artery originates from the aortic arch. (NCI)
Old Def: The flexible prolongated structure of the posterior part of an animal's body. (NCI)
Change to: The appendage that extends from the posterior trunk of animals. (Dorland, W. A. N. (2007). Dorland's illustrated medical dictionary. Philadelphia, PA: Saunders.)
Old Def: The region of the body that includes the arm, the forearm, and hand. (NCI)
Change to: The anterior, front or upper limb of an animal.
Arterial oxygen saturation - This could be a LBTESTCD but most health systems and HL7 CDA categorizes this as a Vital Signs measurement. [Peripheral capillary oxygen saturation (SpO2) is an estimation of the oxygen saturation level usually measured with a pulse oximeter device.] See Wikipedia http://en.wikipedia.org/wiki/Oxygen_saturation_(medicine).
File emailed separately. CDISC_Multi_Term_Request(METHOD terms for opthalmic data) Marcelina Hungria 2014-08-18.xls
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File emailed separately. CDISC_Multi_Term_Request(METHOD terms for opthalmic data) Marcelina Hungria 2014-08-18.xls
BOTH: Use of an active comparator control and an inactive placebo control.
DOSE: Use of a dose control, or study product comparing dosage.
NONTRT: A control group not receiving intervention. (possible Synonym = Non Treatment)
Is this an error in the published definition of "Summary (MAX) Heart Rate" (C39779)? (Capitalization has added to aid in your review.)
The MINIMUM time between successive cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI)
If yes, then please also check the definition of "HRMIN" and "Summary (MIN) Heart Rate" (C62096) - "The MAXIMUM time between successive cycles of contraction and subsequent relaxation of the heart, usually expressed as beats per minute, obtained from a set of measurements of the heart rate. (NCI)"
small ducts leading from the testis to the head of the epididymis.
Submitted on behalf of LAB team. New method for LB Test Mapping (Albumin)
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C12432 Spleen Updated Definition: An organ of the hematopoietic and immune systems that consists of two types of tissue, red and white pulp, and is bounded by a fibrous capsule. It is located in the left diaphragmatic region of the abdomen.
C12433 Thymus Updated Definition: A bi-lobed organ of the immune system located in the upper anterior portion of the chest, behind the sternum.
C12405 Uterus Updated Definition: A hollow, thick-walled, muscular organ located within the pelvic cavity. Within the uterus the fertilized egg implants and the fetus develops during pregnancy.
C12813 Vas Deferens Updated Definition: Duct carrying spermatozoa from each epididymis to the urethra.
C12405 Uterus proposed updated definition: A hollow, thick-walled, muscular organ located within the pelvic cavity. Within the uterus the fertilized egg implants and the fetus develops during pregnancy.
C12813 Vas Deferens proposed updated definition: Duct carrying spermatozoa from each epididymis to the urethra.
Ophthalmology Sub-team is part of the MS team, this counts as a TA request. OETEST/OETESTCD and MOTEST/MOTESTCD terms; File emailed separately.
Please add the term Buprenorphine to the Laboratory Test Name codelist with the test code BUPREN.
Buprenorphine is a semi-synthetic opioid analgesic that can be ordered as a stand-alone test or can be added to an existing drugs-of-abuse testing panel.
IIITo be used with SDTM_LBTEST Human beta-defensin 2
Definition: The measurement of the Human beta-defensin 2 peptide in a biological sample
Additional Info: Beta-defensin 2 (BD2) is also know as skin-antimicrobial peptide 1 (SAP1).
Human ?-Defensin 2 (HBD-2) is a 4.3 kDa cysteine-rich cationic low-molecular weight peptide recently discovered in psoriatic lesional skin and in the infected lung epithelia of patients with cystic fi brosis. Human ?-Defensin 2 is produced by stimulation of Epithelial cells with microorganisms such as cytokines TNF-alpha and IL-1 beta. It is speculated that Human ?-Defensin 2's role is to protect the local epithelial and respiratory tract from infection, providing a possible reason why skin and lung infections with Gram-negative bacteria are rather rare. In addition to their direct antimicrobial activities, they are chemoattractant towards immature dendritic cells and memory T cells.
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To be used with SDTM_LBTESTCD HBD2
Definition: The measurement of the Human beta-defensin 2 peptide in a biological sample
Additional Info: Beta-defensin 2 (BD2) is also know as skin-antimicrobial peptide 1 (SAP1).
Human ?-Defensin 2 (HBD-2) is a 4.3 kDa cysteine-rich cationic low-molecular weight peptide recently discovered in psoriatic lesional skin and in the infected lung epithelia of patients with cystic fi brosis. Human ?-Defensin 2 is produced by stimulation of Epithelial cells with microorganisms such as cytokines TNF-alpha and IL-1 beta. It is speculated that Human ?-Defensin 2's role is to protect the local epithelial and respiratory tract from infection, providing a possible reason why skin and lung infections with Gram-negative bacteria are rather rare. In addition to their direct antimicrobial activities, they are chemoattractant towards immature dendritic cells and memory T cells.
See attached Spreadsheet. These terms already exist in the CV Terminology spreadsheet but we need to assign request codes to them; File emailed separately.
See attached Spreadsheet. These terms already exist in the CV Terminology spreadsheet but we need to assign request codes to them.File emailed separately.
Move some existing terms to the Morphology Test codelists; File emailed separately.
Move some existing terms to the Morphology Test codelists; File emailed separately.
PK team wants to update the CDISC definitions for terms that are used by both SDTM-UNIT and SDTM-PKUNIT codelists; File emailed separately.
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PK team wants to add a new term to the SDTM-UNIT codelist. This term already exists in the SDTM-PKUNIT codelist; File emailed separately.
This is for the Oncology team. All of these terms are already in the Oncology Terminology Spreadsheet. They are being submitted to get a request number; File Emailed Separately.
Add new terms to EGTEST/CD and ECG Result codelists. Already exists in the ECG spreadsheet, just need a request #.
Modify terms in EGTEST/CD and ECG Result codelists. Already exists in the ECG spreadsheet, just need a request #.
Remove green shaded concepts from the current codelist. They will be moved to the MO domain.
Green shaded columns are propose to be moved to and created in the MO domain based on strucutre as part of their definition.
See attached spreadsheet of CVEXAMCD code-list. File EMAILED separately. Yellow shaded rows need confirmation that they are physiology based tests.
Update definition to broaden concept to include multiple species of COTTON RAT: The rat of the genus Sigmodon.
To broaden its use and since the term 'Rat' is non-taxanomic, update definition to: Any of numerous species of small rodents belonging to the genus Rattus and various related genera of the family Muridae.
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I was asked to confirm the use of single quotes ( ? ) in the CDISC Submission values for various codelists. According to our statisticians - a single quote causes issues in SAS by turning the character into an upside question mark ( ). �There are certain other characters that create issues in SAS. But the only other one that we are seeing besides the single quote ( ' ) is the greater than sign ( > ).
Single quote is seen in both the general terminology codelists as well as the questionnaire codelists. Greater than sign is seen in the general terminology spreadsheet.
Is it OK to remove the single quotes and > signs from the terminology or how should it be handled during submissions.
Thanks in advance for your help in answering our questions.
Please add Lysine as a LBTEST/LBTESTCD. Lysine is an essential amino acid produced in the body that has multiple functions such as calcium absorption, muscle repair and growth and production of hormones, enzymes and antibodies. It also acts as a depressant on the nervous system and contains anti-seizure properties. A urine amino acid test or a plasma amino acid test can measure the levels of all amino acids in your body and determine whether you have an imbalance. Normal lysine levels in children should be 19 to 140 micromol/dL while adults should be 32 to 290 micromol/dL. Suggested LBTEST NAME: Lysine and LBTESTCD: LYSINE
http://www.ehow.com/how_7984564_test-serum-lysine.html
Add new terms to the SDTM Microorganism codelist; Multiple Term Request, file emailed separately.
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DLQI1: Dermatology Life Quality Index (DLQI) (copyright AY Finlay, GK Khan, April 1992).
WLQ01: Work Limitations Questionnaire (WLQ) (copyright 1998. The Health Institute; Debra Lerner, PhD., Benjamin Amick, III, PhD., and GlaxoWellcome, Inc. All rights reserved).
Copies of the CRFs will be mailed to Bernice Yost and Jordan Li separately. Copyright permissions for CDISC use are being purused, but have not yet been secured.
For % 'Percentage', Please add the word 'Percent' as a Synonym. Although it's comprehensible, having 'Percentage'as a decode on a CRF just feels 'clunky'.
The Tanner Scale could probably fit into multiple domains, MO, PE, RP, a TBD physiological Findings Class domain. I have selected MO for the purpose of the new term request. Please note, the NCI-T has defined a term for the Tanner Scale: http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C82394&ns=NCI_Thesaurus. Additional information about the Tanner Scale can be found here: http://healthvermont.gov/family/toolkit/tools%5CJ-1%20CARD%20Tanner%20Stages.pdf.
As noted in literature, the Tanner Scale is location based. I am assuming one TESTCD/TEST will be defined and LOC will differentiate the scale being reported. As CDISC has done for ECG findings, it would be helpful to define standardized results for each scale.
Having withdrawn from employment at the conclusion of one's working or professional career.
A person whom an individual knows, likes, and trusts. III
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By default the test name should also be the synonym for both the TEST and TESTCD. This default was missed so Thyroglobulin needs to be added as a CDISC synonym to C103446. This is a type I request and should be fixed with P19.
Proposed updates to CDISC submission values and synonym for the SEND trial summary parameter name and code codelists. 'of' shouldn't be capitalized in CDISC submission values; File emailed Separately.
A period in a clinical study, for example with a crossover design, during which the subject receives a first treatment.
A period in a clinical study, for example with a crossover design, during which the subject receives a second treatment.
A period in a clinical study, for example with a crossover design, during which the subject receives a third treatment.
A period in a clinical study, for example with a crossover design, during which the subject receives a fourth treatment.
A period in a clinical study, for example with a crossover design, during which the subject receives a fifth treatment.
A period in a clinical study during which information about the health status of an individual is obtained after treatment has concluded, however study procedures are ongoing.
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A period of time in a clinical study between Treatment Periods, for example with a crossover design, when a participant is first taken off study drug or other medication to eliminate the effects of the treatment.
A period of time in a clinical study between Treatment Periods, for example with a crossover design, when a participant is taken off study drug or other medication for the second time to eliminate the effects of the treatment.
A period of time in a clinical study between Treatment Periods, for example with a crossover design, when a participant is taken off study drug or other medication for the third time to eliminate the effects of the treatment.
A period of time in a clinical study between Treatment Periods, for example with a crossover design, when a participant is taken off study drug or other medication for the fourth time to eliminate the effects of the treatment.
A period of time in a clinical study between Treatment Periods, for example with a crossover design, when a participant is taken off study drug or other medication for the fifth time to eliminate the effects of the treatment.
Add Spinal Column as a synonym. The repro team is using VERTEBRAL COLUMN as their submission value in FXLOC codelist so they felt it was necessary to add Spinal Column as a synonym.
Repro team is suggesting this update to make the definition less human specific.
A disorder resulting from the presence and activity of a microbial, viral, or parasitic agent. It can be transmitted by direct or indirect contact. -- 2003 (NCI)
A disorder resulting from the presence and activity of a microbial, viral, or parasitic agent. It can be transmitted by direct or indirect contact. (NCI)
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ASPERGILLUS TERREUS - Any fungal organism that can be assigned to the species Aspergillus terreus.
RHIZOMUCOR - Any fungal organism that is not assigned to the species level but can be assigned to the Rhizomucor genus level.
CANDIDA INTERMEDIA - Any fungal organism that can be assigned to the species Candida intermedia.
Our clearance unit in Phoenix / PKS is (mg/kg/day)/(hr*ng/mL); we cannot see any reasonable conversion factor to transform the value into an available PKUNIT in Controlled Terminology relevant to ""Clearance"". Therefore, we are asking for a new PKUNIT to be added. Currently we need it for SEND Terminology, but I see PKUNIT is in the SDTM CT. We need this new PKUNIT for our corresponding pk parameter; PKPARMCD=CLFO
Attached is our terminology request for the Influenza TAUG and a copy of the guide for context. I tried to complete as much of the spreadsheet as possible but neither I nor our SMEs are great at definition writing so we left many of them blank. Our SMEs did say that they would be happy to review any draft definitions that were created. Please let me know if you have questions.
Create new codelist and new terms in this codelist. Virologic Response terms, synonyms, and definitions are attached.
New questionnaires for EXACT-PRO, E-RS, CRQ-SR, CRQ, CAT, SOBDA, CCQ (24 hours and 1 week versions), PGA, and PSQI. The request, copyright permission info/URL and CRF supporting information are attached.
A unit of a mass fraction expressed as a number of micrograms of substance per gram of mixture.
PKUNIT currently has only "/h" as an inverse time unit (to be used with LAMZ). It is desirable to add "/min" and "/day" to provide for alternative time scales. All three time scales are provided in various other units (eg AUC units).
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PKUNIT currently has only "/h" as an inverse time unit (to be used with LAMZ). It is desirable to add "/min" and "/day" to provide for alternative time scales. All three time scales are provided in various other units (eg AUC units).
I suggest changing this submission value and the accompanying synonym. MIDPTLST is defined as ""The midpoint of collection interval, which is associated with last Measurable rate"". This definition is very similar to the definition for ERTMAX, ""The midpoint of collection interval associated with the maximum excretion rate"". I suggest changing MIDPTLST to ERTLST using ERTMAX as the model. Since there are many terms beginning with ER (excretion rate), it seems reasonable to suggest changing MIDPTLST to look like ERTMAX rather than changing ERTMAX to look like MIDPTLST. Further, I suggest changing the synonym for MIDPTLST from ""Midpoint of Collection Interval"" to ""Time of Last Nonzero Excretion Rate"" using the synonym of TLST as the model.
18F NaF PET Definition: A procedure used to find out if cancer has spread to the bone. A small amount of a radioactive substance called fluorine F 18 sodium fluoride is injected into a vein. A PET scan is then used to make detailed pictures of the bones. Bones with cancer in them take up more fluorine F18 sodium fluoride than normal bones do. NCI Thesaurus Code: C93202
SPECT SCAN Definition: A type of tomography in which gamma photon-emitting radionuclides are administered to the patient and then detected by one or more gamma cameras rotated around the patient. From the series of two-dimensional images produced, a three-dimensional image can be created by computer reconstruction. NCI Thesaurus Code: C17203
BONE SCAN Definition: A nuclear imaging method used to evaluate pathological bone metabolism. NCI Thesaurus Code: C17646
Definition : Administration after biting something continuously.
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Definition : Administration within or into a vein or veins or Administration within a muscle.
I have the case which we cannot know either INTRAVENOUS or INTRAMUSCULAR. In this case, how we convert this data to SDTM?
We need to either add a term or replace the existing term (IC50T/IC50 Treatment Result; ccode = C116247). The term "Treatment Result" is too generic as both the subject sample and the lab control are exposed to the treatment drug. The corresponding IC95T variable should also be modified.
