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Reference cardRegulations and guidance

Someone said 'E3'. What is that, and is it the GCP guideline?

ICH E3 is the guideline on the structure and content of clinical study reports. It sets out one core report format that all ICH regions can accept, with regional requirements handled in appendices. FDA published it as a final guidance in July 1996. It is not the GCP guideline, which is ICH E6.

Open the official source
Official sourceFDA: E3 Structure and Content of Clinical Study Reportswww.fda.gov
Checked on October 13, 2026

Next steps

  • See the E3 Questions and Answers (R1) document on the FDA site.