What's included

What gets tested before sign-off

  • Test data sets constructed to trigger every SAS-programmed cross-domain check, including edge cases and boundary values
  • Round one execution against the full check specification, with every discrepancy logged and routed back to programming
  • Round two re-test limited to confirming each logged issue is resolved and no new issue was introduced
  • Check logic verified against CDASH-aligned field structures so downstream SDTM derivations aren't compromised
  • UAT sign-off documentation retained as part of the study's audit trail

Confidence before conduct starts

Ensures cross-domain logic behaves correctly before it's relied on to flag real discrepancies.

The last build gate before launch

Once this and edit checks UAT both pass, the database is ready for go-live.