A second, independent check
This QC step is separate from and additional to the reconciliation performed as part of database lock, giving the sponsor two independent confirmations before committing.
What's included
What goes into the QC check
- Independent verification of analysis population counts against the SAP's population definitions
- Spot checks of key derived variables and CDISC-aligned analysis datasets against source data
- Confirmation that outstanding queries and data management sign-offs are closed before lock
- A final data completeness and consistency check, run separately from the data management database lock process
- A documented go/no-go recommendation to the sponsor ahead of lock
What lock unlocks
Once lock is called, TLFs move to post-DBL finalization against the confirmed dataset.