Clinical Study Report Appendices Section
ICH E3 places specified supporting materials and individual-patient/listing material in CSR appendices, and the FDA-hosted E3 Q&A clarifies that documents needed to review the CSR should be included even when copies also exist in the Trial Master File. Do not treat the CSR appendix as a substitute for the Trial Master File or as permission to include every trial record. Include the material required for CSR review and any region-specific additions.
A Clinical Study Report Appendices section organizes the protocols, analysis documentation, forms, investigator/site material, patient listings, and other supporting records needed to review the study report.
Key details
Important caveats
Scope Boundary
Do not treat the CSR appendix as a substitute for the Trial Master File or as permission to include every trial record. Include the material required for CSR review and any region-specific additions.
Further guidance
Content
Use the applicable E3/CTD/regional structure to place supporting documents and listings where reviewers can locate them without overloading the main report body.
Purpose
A Clinical Study Report Appendices section organizes the protocols, analysis documentation, forms, investigator/site material, patient listings, and other supporting records needed to review the study report.
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
- E3 Structure and Content of Clinical Study Reports — Questions and Answers (R1) (opens in a new tab)U.S. Food and Drug Administration · FDA-hosted ICH E3 questions and answers clarifying the CSR synopsis and core report implementation