Monday, December 6, 2010

E3: Structure and Content of Clinical Study Reports

Structure and content of clinical study report

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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