Analysis Data Reviewer's Guide (OBX319-301)

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

Analysis Data Reviewer's Guide (ADRG) — OBX319-301

Orients the reviewer to the ADaM datasets for OBX319-301: analysis-set derivations (ADSL flags), the BDS structures (ADLB/ADVS/ADAE) and the time-to-event dataset (ADTTE), traceability from SDTM to ADaM to the TFL outputs, and any analysis conventions. Conformance is summarised in the CDISC validation report. CDISC ADaM; Define-XML 2.1.