To submit study data to theFDA in CDISC SDTM format, the sponsor mustmap and transformthe collected data from the study’s operational database (e.g., EDC) intoSDTM-compliant domains.
According toGCDMP (Chapter: Standards and Data Integration)andCDISC SDTM Implementation Guide, this process includes:
Mappingraw data elements from the clinical database to SDTM domains (e.g., DM, AE, VS).
Transformingdata to comply with SDTM structural and naming conventions.
Validatingthe output using CDISC compliance tools (e.g., Pinnacle 21).
Re-entering data (B) is unnecessary, and a letter of intent (C) is not required. SDTM is explicitly accepted by FDA for both retrospective and prospective submissions, so (D) is incorrect.
Thus,option Ais correct —map and transform existing data to SDTM formatfor regulatory submission.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Standards and Data Integration, Section 5.3 – Data Transformation and CDISC Mapping
CDISC SDTM Implementation Guide, Version 3.4 – Data Conversion and Submission Requirements
FDA Study Data Technical Conformance Guide, Section 2.2 – SDTM Mapping and Validation
