U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. E3 Structure and Content of Clinical Study Reports
  1. Search for FDA Guidance Documents


E3 Structure and Content of Clinical Study Reports July 1996

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The objective of this guideline is to facilitate the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The regulatory authority-specific additions will consist of modules to be considered as appendices, available upon request according to regional regulatory requirements.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-1995-D-0201.

Back to Top