ADaM Dataset Specification (OBX319-301)
Document ID: ADaM-SPEC-301
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): CDISC ADaM
ADaM Dataset Specification — OBX319-301
The ADaM dataset specifications for OBX319-301: ADSL and the BDS datasets (ADLB/ADVS/ADAE) and the time-to-event dataset (ADTTE), with variable-level metadata, derivations, and controlled terminology, providing SDTM-to-ADaM-to-results traceability. CDISC ADaM; Define-XML 2.1.