ICH E3 - Structure and Content of Clinical Study Reports

What it says

E3 provides a standard structure and content for a clinical study report so a single report is acceptable to regulatory authorities in all ICH regions. It sets out the sections, from synopsis, ethics and study design to efficacy and safety results, discussion and conclusions, and the appendices, such as protocol, sample consent form and listings.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A clear, standard report structure helps reviewers find information and compare studies.
• The report must accurately reflect the protocol, any amendments and deviations, and the analysis actually performed.
• It forms the basis for Module 5 of the Common Technical Document.

What inspectors look for

• Whether the report is consistent with the protocol, plan and source data.
• Whether deviations and amendments are described.
• Whether results presented can be traced back to the data.

Related regulations