Study Data Reviewer's Guide (OBX319-301)

Document ID: DEF-301-SDRG
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): CDISC SDTM

Study Data Reviewer's Guide (SDRG) — OBX319-301

Orients the reviewer to the SDTM datasets for OBX319-301: 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.