No surprises at programming
Because shells are reconciled to the SAP before programming starts, TLF production runs against a specification, not a moving target.
What's included
What goes into finalization
- Line-by-line reconciliation of every mock shell against the final SAP's populations, endpoints, and statistical methods
- Removal of shells for analyses dropped by amendment, and addition of shells for any new endpoints
- Footnote and formatting standardization across the full TLF package for CSR readiness
- Final numbering and ordering aligned to the CSR outline so programmers and medical writers reference the same shell IDs
- Sign-off routed alongside the SAP sign-off so shells and methods lock together
Started early, finished on time
This step closes out the mock shells work begun during Mock Shells / TLF Shells Development at study start-up.