Very Large Trial Clinical Study Report Format
ICH E3 recognizes that some provisions may be impractical or inappropriate for very large trials and encourages contact with regulatory authorities when planning and reporting an appropriate format. This is not a blanket exemption from E3 content; it is a format-planning boundary for very large trials.
For a very large trial, adapt the CSR format only with the study context and reviewing authority in view rather than mechanically forcing every ordinary-format convention.
Key details
Important caveats
Scope Boundary
This is not a blanket exemption from E3 content; it is a format-planning boundary for very large trials.
Further guidance
Content
Identify which ordinary E3 provisions become impractical, preserve the information needed for review, and discuss the proposed report format with the authority when appropriate.
Purpose
For a very large trial, adapt the CSR format only with the study context and reviewing authority in view rather than mechanically forcing every ordinary-format convention.
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