CDISC Conformance Validation Report — OBX319-301
Document ID: DEF-301-VAL Version: 1.0 Effective: 2026-07-09 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 | 2026-07-09 | Data Management | Initial automated subset validation |
Summary — Errors: 0 · Warnings: 0 · Datasets checked: 9
No issues found across the implemented rule subset. ✅