E3 Clinical Study Reports
E3 Structure and Content of Clinical Study Reports
The ICH Harmonised Guideline was finalized under Step 4 in November 1995. This document describes the format and content of a clinical study report that will be acceptable to all regulatory authorities of the 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.
Date of Step 4: 30 November 1995
Status: Step 5
Guidelines (Click the links below for complete guidelines)
E3 Q&As (R1) Questions & answers: Structure and Content of Clinical Study Reports
Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the E3 Guideline have resulted in the need for some clarification. This supplementary Questions and Answers document intends to clarify key issues. In July 2012, minor typographical errors were corrected in the Answer to Question 6 and the document was renamed R1.
Date of Step 4: 6 July 2012
Status: Step 5
Questions and Answers (Click the links below for complete guidelines)
E3 Q&As (R1) Questions & answers
Endorsed Document (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
ICH E3 Clinical Study Reports Guidelines:
