CDISC Conformance Validation Report — GLPI103-301
📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The CDISC conformance validation report — the results of checking the datasets against the SDTM/ADaM standards.
Why it exists. Regulators expect datasets to pass conformance checks. This report documents the checks run and their findings, showing the data are submission-legal (or explaining any accepted deviations).
How it is produced here. It is generated from the standardized study datasets (the SDTM and ADaM data and their define.xml 'data dictionary'), so the guide always describes the exact datasets a regulator would receive.
Format & governing standard. —
CDISC Conformance Validation Report — GLPI103-301
Document ID: DEF-301-VAL Version: 1.0 Effective: 2026-06-29 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 | 2026-06-29 | Data Management | Initial automated subset validation |
Summary — Errors: 0 · Warnings: 0 · Datasets checked: 10
No issues found across the implemented rule subset. ✅
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