The line between conduct and close-out
This is the checkpoint where final TLF production output gets formally confirmed against the locked database and declared final.
What's included
Confirming and freezing datasets and TLFs at database lock
- Final SDTM and ADaM datasets regenerated one last time against the locked database and confirmed identical to the pre-lock dry-run version
- Final TLFs re-verified against the locked-data datasets, with any last-mile discrepancies logged and resolved
- Independent double programming confirmation on primary and key secondary outputs before the freeze
- A documented lock record — timestamps, program versions, and sign-offs — establishing what "final" means for this study
- Frozen datasets and outputs handed off for CSR support and archival with no further edits permitted
What gets archived is what was locked
The frozen dataset and TLF set feeds directly into statistical programming deliverables archival, with no ambiguity about which version is authoritative.