E3: Structure and Content of Clinical Study Reports

Regulatory Resource: E3: Structure and Content of Clinical Study Reports

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in November 1995. This document describes the format and content of a study report that will be acceptable in all three ICH regions. It consists of a core report suitable for all submissions and appendices that need to be available but will not be submitted in all cases.

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