Traceable back to source
Everything archived here traces to the same package verified in statistical QC of the database, so the archive can withstand independent reproduction.
What's included
What goes into the archive
- The final signed-off SAP and every prior approved version, with a documented amendment history
- All production and QC analysis programs, retained in a runnable, documented state
- The final TLF package confirmed in post-DBL TLF finalization, alongside the pre-lock QC record
- The unblinding log, where applicable, retained with the same access controls used during the study
- A file index and retention record that maps every archived item to its regulatory purpose, ready for sponsor or inspector request
Ready before it's asked for
Archival is built to be inspection-ready from day one, not assembled reactively when a request for the unblinding record or SAP history arrives.