Abbreviated Clinical Study Report
ICH E3 states that an abbreviated report may be acceptable in certain circumstances depending on regulatory review policy, while controlled safety studies should be reported in full and safety aspects should remain fully described. Abbreviation is context- and authority-dependent, not a general shortcut for efficacy or safety reporting; controlled safety studies are specifically treated differently in ICH E3.
Use an abbreviated CSR only where the reviewing authority’s policy and the study context permit it, while preserving a full safety description and enough design/results detail for review.
Key details
Important caveats
Scope Boundary
Abbreviation is context- and authority-dependent, not a general shortcut for efficacy or safety reporting; controlled safety studies are specifically treated differently in ICH E3.
Further guidance
Content
If sections are summarized or deleted, retain enough information for the authority to decide whether a full report is needed and consult the authority when the reporting level is uncertain.
Purpose
Use an abbreviated CSR only where the reviewing authority’s policy and the study context permit it, while preserving a full safety description and enough design/results detail for review.
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