What's included

What goes into the final validation pass

  • Final SDTM & ADaM conformance checks against the locked, close-out datasets
  • Findings resolved or documented before the package is called final
  • Run against current CDISC-aligned rule sets
  • Results carried directly into eSubmission package preparation

The last check before it's final

This pass runs against the locked, post-database-lock datasets — the version that actually ships in the submission package, not an interim snapshot.