Samples / TILA-278 / regulatory/m5-clinical/sap/ADaM-SPEC-201_dataset_specification.md

ADaM Dataset Specification (TILA278-201)

Document ID: ADaM-SPEC-201
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): CDISC ADaM

ADaM Dataset Specification — TILA278-201

The ADaM dataset specifications for TILA278-201: 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.