Statistical Documentation Appendix
ICH E3 appendix 16.1.9 is designated for detailed documentation of statistical methods supporting the analyses summarized in the clinical study report. This appendix is distinct from merely telling readers where a protocol or statistical analysis plan can be accessed and should remain scoped to the ICH E3 CSR structure.
The Statistical Documentation Appendix holds the detailed statistical-method material that supports and expands on the methods described in the CSR body.
Key details
Important caveats
Scope Boundary
This appendix is distinct from merely telling readers where a protocol or statistical analysis plan can be accessed and should remain scoped to the ICH E3 CSR structure.
Further guidance
Content
Place detailed statistical documentation, including the applicable analysis-plan material and supporting method detail, in the designated appendix while keeping enough method description in the report body for reviewers to follow the analyses.
Purpose
The Statistical Documentation Appendix holds the detailed statistical-method material that supports and expands on the methods described in the CSR body.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E3 Structure and Content of Clinical Study Reports (opens in a new tab)U.S. Food and Drug Administration · FDA-hosted ICH E3 guidance defining the structure and content of a core clinical study report