Checked before it's submitted
Drafted input here is verified line by line during statistical review of the CSR before the report is finalized.
What's included
What goes into the statistical sections
- Drafted statistical methods narrative, mapped sentence by sentence back to the signed-off SAP
- Results narrative written directly from the finalized TLFs, with every number traceable to its source table
- Population and disposition summaries reconciled against the analysis dataset counts
- Statistical appendices and in-text tables formatted to ICH E3 structure for direct handoff to medical writing
- Coordination with medical writing so the full CSR reads as one document, not two contributions stitched together
Built on locked outputs
Narrative is written from the same package produced in TLF production and reconfirmed in post-DBL TLF finalization.