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

CDISC Conformance Validation Report — TILA278-201

Document ID: DEF-201-VAL Version: 1.0 Effective: 2026-07-08 Standard: CDISC SDTM-IG / ADaM-IG / Define-XML 2.1 (Pinnacle 21 rule subset)

Generated by tools/validate_cdisc.py — a documented subset of CDISC/Pinnacle 21 rules (required variables, controlled terminology, referential integrity, define↔data consistency). Not a substitute for an official Pinnacle 21 Community report (see SDRG §6).

Change History

Version Date Author Summary
1.0 2026-07-08 Data Management Initial automated subset validation

Summary — Errors: 0 · Warnings: 0 · Datasets checked: 9

No issues found across the implemented rule subset. ✅