When efficacy data arenot covered by existing CDISC SDTM domains, thefirst resourcethe Data Manager should consult is theCDISC Therapeutic Area Implementation Guide (TAIG)for that therapeutic field.
According to theGCDMP (Chapter: Standards and Data Mapping), CDISC’s Therapeutic Area User Guides (TAUGs) and Implementation Guides providestandardized data structures, variable definitions, controlled terminology, and implementation examplesfor specific diseases or therapeutic areas. These guides ensure consistency across studies, promote interoperability, and align data collection with regulatory submission expectations.
Consulting other sponsors’ forms or external registries (options A and C) can be informative but do not provide authoritative CDISC-compliant standards. SNOMED terms (option B) address medical terminology, not structural data domain definitions.
Therefore,Option Dis correct—CDISC TA Implementation Guidesare the recognized primary reference when extending or designing SDTM-compliant CRFs.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Standards and Data Mapping, Section 4.2 – Use of CDISC Standards
CDISC Therapeutic Area User Guides (TAUGs) – Implementation Guidance for Domain Extension
FDA Data Standards Catalog – CDISC Therapeutic Area Standards
