Built alongside the datasets, finalized alongside the lock
Define.xml development starts in start-up, not at the end — final QC here confirms it against Pinnacle 21 validation results rather than reverse-engineering it from scratch.
What's included
Finalizing the metadata that makes datasets reviewable
- Define.xml updated to match the final, locked SDTM and ADaM datasets — every variable, codelist, and value-level metadata entry reconciled
- SDTM Reviewer's Guide (SDRG) and ADaM Reviewer's Guide (ADRG) finalized, documenting mapping decisions, conformance findings, and analysis derivations
- Cross-checks between define.xml, the reviewer's guides, and the annotated CRF for consistency
- Any conformance findings from Pinnacle 21 validation documented and explained, not left unresolved
- Final documents version-controlled and ready to drop into the eSubmission package
The document a reviewer opens first
SDRG and ADRG go straight into eSubmission package preparation — no last-minute rewrite to match what actually shipped.