Embed Size (px)
Citation preview
Diastolic Blood Pressure C25299
CDISC VSTESTCD = “DIABP”
Blood Pressure C54706
The pressure of the circulating blood against the walls of the blood vessels.
Personal Attribute C19332
The distinguishing qualities or prominent aspects of an individual person.
Property or Attribute C35552
The distinguishing qualities or prominent aspect of a person, object, action, process, or substance.
The blood pressure after the contraction of the heart while the chambers of the heart refill with blood.
NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.
Choriogonadotropin Beta Measurement C64851
CDISC LBTESTCD = “HCG”Synonym: “Pregnancy Test”
Protein or Enzyme Type Measurement C64430
Chemistry Test C49237
Laboratory Procedure C25294
A medical procedure that involves testing a sample of blood, urine, or other substance from the body. Tests can help determine a
diagnosis, plan treatment, check to see if treatment is working, or monitor the disease over time.
CDISC Definition: A measurement of the Choriogonadotropin Beta in a biological specimen.
NCI Defintion: A determination of the presence of Choriogonadotropin Beta protein.
NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.
Intervention or ProcedureC25218
Activity or measure that produces an effect or that is intended to alter the course of a disease in patient or population. This is a general
term encompassing medical, social, behavioral, environmental and other acts that can have preventive and/or therapeutic impact. .
Clinical or Research Activity C16203
Any specific activity undertaken during the course of a clinical study or research protocol.
Postpartum HypertensionC35802
Hypertension C3117
Pathological increase in blood pressure; a repeatedly elevated blood pressure exceeding 140 over 90 mmHg
Blood Pressure Finding C54707
A test result that reports the diastolic and systolic pressure of the blood.
Cardiovascular System Finding C35552
Patient complaints (symptoms), physical/laboratory findings(signs) related to the cardiovascular system.
Finding by Site or System C36278
Finding C3367
Objective evidence of disease perceptible to the examining physician (sign) and subjective evidence of disease perceived
by the patient (symptom)..
Disease, Disorder or FindingC7057
Specification of human conditions relevant to cancer. This includes observations, test results, history, and other concepts
relevant to characterization of human cancer-related conditions. Non-neoplastic conditions of interest are also
included.
NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.
CDISC SDTM and related initativies
HL7 “Health Level Seven”
CDISCClinical Data
Interchange Standards Consortium
Re
latio
nsh
ip H
L7
/CD
ISC
RCRIMRegulated Clinical Research
and Information Management,
technical committee
SDTM variables specifiedas packages of Controlled
TerminologiesPublished as an Excel matrixeson CDISC website
NCI Thesaurus In OWL format
BRIDGBiomedical
Research Integrated Domain Group Model
All terms and conceptsare incorporated from
NCI Thesaurus thorugh NCI EVS
UMLS
CDISC’s Controlled Terminoligy for VSTEST Codesas part of package 1
Published as an Excel matrixeson CDISC website
Vital Signs Test Name
Observation
Action
Heart Rate“HR”
Pulse Rate“PULSE”
Respiratory Rate“RESP”
Personal Attribute
Characteristic
Weight“WEIGHT”
Property or Attribute
Blood Pressure
Diastolic Pressure“DIABP”
Systolic Pressure“SYSBP”
Body Mass Index“BMI”
Temperature“TEMP”
Conceptual Entities
Height“HEIGHT”
Mean Arterial Pressure“MAP”
Blood Pressure Finding
Cardiovascular System Finding
Finding by Site or System
Body Frame Size“FRMSIZE”
Adipose Tissue“BODYFAT”
Soft Tissue
Body Surface Area“BSA”
Connective and Soft Tissue
Tissue
Microanatomic Structure
Anatomic StructureSystem or Substance
Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes
NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.
Vital Signs Test Name
Observation
Action
Heart Rate“HR”
Pulse Rate“PULSE”
Respiratory Rate“RESP”
Personal Attribute
Characteristic
Weight“WEIGHT”
Property or Attribute
Blood Pressure
Diastolic Pressure“DIABP”
Systolic Pressure“SYSBP”
Body Mass Index“BMI”
Temperature“TEMP”
Conceptual Entities
Height“HEIGHT”
Mean Arterial Pressure“MAP”
Blood Pressure Finding
Cardiovascular System Finding
Finding by Site or System
Body Frame Size“FRMSIZE”
Adipose Tissue“BODYFAT”
Soft Tissue
Body Surface Area“BSA”
Connective and Soft Tissue
Tissue
Microanatomic Structure
Anatomic StructureSystem or Substance
Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes
The blood pressure after the contraction of the heart while the chambers of the heart refill with blood.
NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.
Vital Signs Test Name
Observation
Action
Heart Rate“HR”
Pulse Rate“PULSE”
Respiratory Rate“RESP”
Personal Attribute
Characteristic
Weight“WEIGHT”
Property or Attribute
Blood Pressure
Diastolic Pressure“DIABP”
Systolic Pressure“SYSBP”
Body Mass Index“BMI”
Temperature“TEMP”
Conceptual Entities
Height“HEIGHT”
Mean Arterial Pressure“MAP”
Blood Pressure Finding
Cardiovascular System Finding
Finding by Site or System
Body Frame Size“FRMSIZE”
Adipose Tissue“BODYFAT”
Soft Tissue
Body Surface Area“BSA”
Connective and Soft Tissue
Tissue
Microanatomic Structure
Anatomic StructureSystem or Substance
Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes
(Pulse)
The rhythmic wave within the arteries occurring with each contraction ofthe left ventricle.
The rate of the pulse as observed in an artery, expressed as beats per minute. It can be measured at several anatomical sites, including the wrist, neck, temple, groin, behind the knees, or on top of the foot.
NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.
Topic Identifier TimingGrouping
QualSynonym
Qual Res
ResQual
VarVar
Qual
RecordQual
Res
Generic dataset structure for all domainsBased on the descriptions in the Study Data Tabulation Model document
Example from CDISC SDTM Implementation Guideline version 3.1.2
VSTESTCD VSORRES
VSPOSVSLOC
Hypertension can be seen as a Risk Factor in SDTM Medical History for a specific clinical study
A CRF (Case Report Form) asks whether or not the subject had any of a list of 4 specific risk factors, including hypertension, and there is a space for the investigator to write in other risk factors.
In SDTM this is classified as a Medical History and below is an example on row 7 describing how a (sligfhly simplified) record in a MH domain could look like
Example from CDISC SDTM Implementation Guideline version 3.1.2
Pregnancy can be seen as a type of Disposition event in SDTM domain for Disposition for a specific clinical study
From CDISC SDTM Implementation Guideline version 3.1.2, to be published as a controlled terminioligy
Primary Usein Health Care
per patient
Primary use inDrug Development (i.e. Secondary Use of Health Care data in clinical research)
Secondary Usein Drug Developmentas Knowledge Base
Secondary UseEpi / Population / Real life analysis
Secondary Usein Health Care
as Knowledge Base
Patient
Subject
Organizing clinical trials information that is to be submitted to the FDA.
SDTM
Auhortities
Population
![STATISTICAL ANALYSIS PLAN (SAP)Laboratory tests (blood chemistry, hematology, and urinalysis) Vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate)](https://img.pdfslide.net/doc/110x75/61279e6a12637b477c1e6392/statistical-analysis-plan-sap-laboratory-tests-blood-chemistry-hematology-and.jpg)
