Output generation
TLFs generated from mock shells defined in the statistical analysis plan, keeping outputs traceable back to their specification.
What's included
What goes into the mock shells
- Table, listing, and figure shells drafted directly from the SAP's methods and population specifications
- Titles, footnotes, and column structures laid out so programming can build against them without rework
- Shells organized to map cleanly onto SDTM/ADaM structures ahead of production
- Shell package reviewed against the protocol's endpoints before it moves to final sign-off
- Finalized later against the locked SAP at TLF Shells Finalization, then produced at TLF Production after database lock
Validation & reporting handoff
Independent programming checks on primary and key secondary outputs before tables move into clinical study report writing.