Samples / TILA-278 / regulatory/m5-clinical/define/DEF-201_SDRG.md

Study Data Reviewer's Guide (TILA278-201)

Document ID: DEF-201-SDRG
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): CDISC SDTM

Study Data Reviewer's Guide (SDRG) — TILA278-201

Orients the reviewer to the SDTM datasets for TILA278-201: the trial-design domains, the collected subject-level domains (DM/SC/VS/LB/AE), controlled terminology, and known conformance findings with rationale. CDISC SDTM; Define-XML 2.1.