Locked before the data is
Sign-off happens ahead of database lock, closing the door on post-hoc changes to methods once results are visible — the same discipline established in the original SAP development.
What's included
What goes into sign-off
- Final reconciliation of the SAP against the locked protocol and all approved amendments
- Confirmation that every analysis population, endpoint definition, and missing-data rule matches what is programmed
- Cross-check of the SAP against the finalized TLF shells to confirm every planned output has a specified method
- Version control and a documented approval trail, with signatures dated ahead of database lock
- Distribution of the signed-off SAP to programming, data management, and medical writing as the single source of truth for analysis
The reference for everything downstream
Programming for TLF production and drafting for the CSR both work from this single signed-off version.