Database lock should confirm a prepared delivery system—not trigger a scramble to define it. The highest-value readiness review makes inputs, specifications, roles and release criteria explicit before final data arrive.
Questions to resolve
- 01
Confirm source extracts, transfer format, timing and ownership
- 02
Approve SDTM and ADaM specifications and identify unresolved derivations
- 03
Approve TLF shells and connect each output to its analysis source
- 04
Agree production and validation responsibilities, issue handling and evidence
- 05
Define the post-lock change process and final release approvals
The exact checklist should follow the protocol, sponsor SOPs, approved systems and agreed acceptance criteria.