Plan development
SAPs built in coordination with sample size assumptions and protocol endpoints, finalized ahead of database lock.
What's included
What goes into the SAP
- Analysis populations (ITT, PP, safety) defined precisely enough for programming to implement without interpretation
- Statistical methods specified for every primary, secondary, and exploratory endpoint
- Missing data and sensitivity analysis rules pre-specified ahead of database lock
- Mock table, listing, and figure shells drafted to drive TLF generation
- Amendment tracking so changes to the SAP stay documented and defensible under review
TLF specification
Mock table, listing, and figure shells specified within the SAP to drive efficient TLF generation once data is locked.