Independent from the drafting team
Review is performed separately from the biostatistician who wrote the statistical input, giving the CSR a second set of eyes before submission.
What's included
What goes into the review
- Full-text review of the CSR's statistical methods and results sections against the signed-off SAP
- Verification of every in-text number, percentage, and p-value against its source TLF
- Confirmation that any deviations from the SAP are disclosed and justified in the report
- Cross-check of appendix tables and in-text tables for consistent formatting and labeling
- A documented set of comments and resolutions before the CSR is released to clinical study report finalization
Nothing left unreconciled
Any discrepancy traces back to either the database QC or the post-DBL TLF finalization that produced the numbers in question.