Copyright © 2012 Quintiles SDTM IG 3.1.4 (Batch 1 – Release for Public Review) Standards for Therapeutic Areas Quintiles QBLM SDTM Forum

Copyright © 2012 Quintiles

SDTM IG 3.1.4(Batch 1 – Release for Public Review)

Standards for Therapeutic Areas

Quintiles QBLM SDTM Forum


Part 1:SDTM IG 3.1.4

(Batch 1 – Release for Public Review)

Quintiles QBLM SDTM Forum

3

SDTM-IG 3.1.4 (Batch 1)

Given the volume of new specialty IG and domains, the SDS Team decided

to divide materials targeted for inclusion in SDTM-IG 3.1.4 into two manageable

batches for public review

• Batch 1 package:

Exposure Domains Supplement:

o Clarification on variables, Added/Updated Variables

o Variables proposed for Deprecation

o New domain is introduced, Exposure as Collected (EC).

Immunogenicity Domains Supplement:

o Immunogenicity Specimen Assessments (IS) {Findings Domain}

o Skin Response (SR) {Findings About Domain}

Reproductive Details Domain Supplement:

o Reproductive Details {Findings Domain}

http://www.cdisc.org/sdtm Public review Aug/Sep

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IG 3.1.4 (Batch 1)

Exposure Domains Supplement :

o Clarification on variables

o Added / Updated Variables



Clarified Definitions

EX Domain: Recognized as a derived dataset

Reflecting Subject Exposure: to protocol-specified study treatment(s), in protocol-specified unit(s)

Reflecting collected information descriptive of doses not taken, not given or missed

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IG 3.1.4 (Batch 1)




Clarified DefinitionsEXDOSU:

Values to reflect protocol-specified unit(s) Derivation from collected unit to protocol-specified unit may be required

EXDOSE: Values to reflect the amount of active ingredient administered in protocol-

specified unit EXDOSE = Number of units (e.g., TABLET) multiplied by Pharmaceutical Strength (active ingredient/unit), adjusted as-needed to protocol-specified unit.

EXVAMT: Values to reflect the total amount of the prepared product (treatment +

vehicle) administered

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IG 3.1.4 (Batch 1)






Added / Updated VariablesAdded as permissible variables : EX domain• EXOCCUR , EXREASND

Definition Updates:

• --DOSE: SDTM definition updated by adding –DOSTOT to the following sentence: ‘Not populated when --DOSTXT or --DOSTOT is populated.’

• --REASND: SDTM definition expanded; used in conjunction with --STAT value of ‘NOT DONE’ or --OCCUR value of ‘N’. .

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IG 3.1.4 (Batch 1)http://www.cdisc.org/sdtm Public review Aug/Sep

Added / Updated Variables (continued)

New Interventions General Observation Class :

-- MOOD Identify records as either ‘SCHEDULED’ or ‘PERFORMED’.

--FAST Describe the fasting status at the time of the administration

--METHOD Describe the method of administration

--PSTRG Reflect the pharmaceutical strength of a treatment defined as the content of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form

--PSTRGU Reflect the associated unit of the pharmaceutical strength (e.g., mg/mL, mg/TABLET).

--DOSTKN Represent the number of doses taken within an interval of time defined by --STDTC and --ENDTC or --DUR.

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IG 3.1.4 (Batch 1)http://www.cdisc.org/sdtm Public review Aug/Sep

Added / Updated Variables (continued)

New General Observation Class :

-- MTHOBS Represent the method of observation (e.g., OBSERVED, AUTOMATED DISPENSEMENT, SUBJECT DIARY, SUBJECT RECALL). If more than one value applies at the record-level, then --MTHOBS should be populated.

--PTTMFL Permissible Timing variable to indicate if an intervention or event occurred at a point in time. If ‘Y’, then --ENDTC must be null. If null, then --ENDTC or --DUR should be populated

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IG 3.1.4 (Batch 1)






DeprecationEXDOSTOT: was not intended to reflect a derived total daily dose (EXDOSE multiplied by EXDOSFRQ). Deprecation of this variable allows exposure dose representation to be in a single variable (i.e., EXDOSE) and eliminates inconsistent implementations of the variables across industry. • (--DOSTOT will be deprecated (phased out) by the next (post v1.4 / v3.1.4) release )TAETORD: Deleted from EX domain table; intended use in the domain was unclear.EXVAMT and EXVAMTU: With the addition of the EC domain model and use of FA to represent doses in

alternative units, EXVAMT and EXVAMTU will be deprecated (phased out)

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IG 3.1.4 (Batch 1)


o New domain


EC: Exposure as Collected

EC Definition a. The Exposure as Collected domain model reflects protocol-specified study treatment administrations, as-collected. • EC should be used in all cases where collected exposure information cannot or should not be directly represented in EX or DA. For example, administrations collected in tablets but protocol-specified unit is mg, administrations collected in mL but protocol-specified unit is mg/kg, or administration details are collected as Drug Accountability. • If EC is an exact duplicate of EX, then EC is not necessary. • Exposure data are either represented in EX only or EC & EX or DA & EX.

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IG 3.1.4 (Batch 1)

Immunogenicity Specimen Assessments (IS) :


Domains introduced in IG 3.1.4

Definition:The Immunogenicity Specimen Assessments (IS) domain model is used for assessments, which determines whether a therapy provoked/caused/induced an immune response. For example, a vaccine is expected to induce an immune response to the therapeutic agent. Alternatively, a cellular therapy such as Erythropoiesis stimulating agents may induce an immune response that is not desired.

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IG 3.1.4 (Batch 1)

Skin Responses (SR):



Definition:

The SR domain is a Findings About domain used to submit dermal responses to antigens. The method of assessment is typically a skin-prick test.

Because a subject is typically exposed to many test materials at the same time. SROBJ is needed to represent the test material for each response record. .

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IG 3.1.4 (Batch 1)

Reproductive Details (RD):



Definition:o This domain captures all Reproduction details captured in a study related to the subject in a FINDINGS domain o Many of the findings proposed originated in legacy data conversions. Any new prospective reproductive tests need to be proposed with the CDISC Terminology Committee for formal inclusion o All medication questions related to Reproduction Details should be mapped to the CM Interventions domain and categorized accordingly o The current practice proposed for some Therapeutic Area’s is to populate a subject’s Birth Control Method in the Subject Characteristics (SC) domain. This was a practice based on previous SDTM alignment, with no specific Reproduction type domain existing. This finding should now be populated in the RD Findings domain as RDTESTCD=BCMETHOD and RDTEST=Birth Control Method to formalize the capture of this data value

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Part 2: Therapeutic Area Standards

QBLM SDTM Forum

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Therapeutic Specific Standardshttp://www.cdisc.org/therapeutic

Draft Standards up for public review:

Virology Draft StandardsThis is CDISC’s first attempt to develop submission standards for virology-focused

trials. This document contains 5 proposed new SDTM domains, which includes basic information gene expression, human genetic variation, viral genetics and resistance data.

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Therapeutic Specific Standardshttp://www.cdisc.org/sdtm

Draft Standards up for public review:

Parkinson’s Disease Therapeutic Area User GuideThis is a supplement to the SDTM User Guide and will be used with the SDTMIG. It will guide the user in the organization, structure and format of standard Parkinson’s disease clinical trial tabulation datasets. The PD User Guide includes the following in the review package:• Assumptions and examples for using 10 existing SDTM standard domains implemented with PD specific common data elements.

• Draft domains and examples for 5 new SDTM draft domains that are important for PD and are included here to provide context for reviewers.

• Mapping and examples for the core questionnaires, along with their SDTM annotated CRF’s

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Therapeutic Specific Standardshttp://www.cdisc.org/sdtm

Standards Available Pain Therapeutic Area Standards• User Guide, • 19 Questionnaire Supplements• 13 SDTM Annotated CRFs.(CT relevant to this PAIN User Guide is being been prepared through the CDISC Terminology Team and will be released as part of terminology package 12)

Tuberculosis Therapeutic Area User Guide Includes 4 Draft Domains:• Device in Use (DU) • Morphology (MO) • Microscopic Findings (MI)• Skin Response (SR)

(CT relevant to this TB User Guide is being been prepared through the CDISC Terminology Team and will be released as part of terminology package 12)

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Therapeutic Specific Standardshttp://www.cdisc.org/therapeutic

Standards Available

Alzheimer’s disease/Mild Cognitive Impairment User Guide• This document comprises version 1.0 of the Alzheimer's disease-specific Therapeutic Area Supplement User Guide ((SDTMUG-ALZHEIMERS v1.0). • This guide describes the explicit implementation of a subset of the existing and new SDTM safety domains.• The Questionnaires selected for standardization in Alzheimer's disease studies• The UG describes the assumptions and rules for the SDTM domains, a data example of specific domains and a SDTM mapping strategy as necessary

The CDISC Questionnaire Terminology Team in the process of assessing copyright issues and developing controlled terminology for questionnaires. The CDISC website will be updated on a regular basis to inform you of their progress

Documents

Copyright © 2012 Quintiles SDTM IG 3.1.4 (Batch 1 – Release for Public Review) Standards for Therapeutic Areas Quintiles QBLM SDTM Forum