The narrative half of reviewer support
Our statistical programming team builds the SDTM/ADaM reviewer's guide for the data side of the submission; this deliverable covers the narrative documentation that sits alongside the full CSR.
What's included
What goes into reviewer support
- Narrative reviewer's guide content drafted to orient a reviewer through the CSR and its appendices
- Cross-references checked between the CSR, patient narratives, and supporting submission documents
- Document-level indexing and navigation aids prepared for the submission package
- Coordination with the statistical programming team so narrative guidance stays consistent with the SDTM/ADaM reviewer's guide
- Terminology and formatting aligned with other submission documents referencing the same study
- Final package reviewed for completeness before it's handed to regulatory affairs for filing
Consistent with the rest of the package
Reviewer's guide content is drafted by the same team writing the CSR and coordinating with CTA/IND documentation, so terminology and cross-references stay aligned across the full submission.
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