The objective of this guideline is to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The regulatory authority specific additions will consist of modules to be considered as appendices, available upon request according to regional regulatory requirements.

The objective of this guideline is to facilitate the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions.

This document aims to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. Read together with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline E3: Questions and answers (R1) .

ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports (PDF - 240KB)

The objective of this guideline is to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The regulatory authority specific additions will consist of modules to be considered as appendices, available upon request according to regional regulatory requirements..

ICH Guidelines. All Guidelines; Quality Guidelines; Safety Guidelines; Efficacy Guidelines; Multidisciplinary Guidelines; Index of Guidelines; ICH Standards. MedDRA; CTD; Electronic Standards (ESTRI) Other Work . Reflection Papers & Discussion Groups; Consideration Documents; CIOMS Glossary of ICH Terms & Definitions; ICH PQKM Task Force ...

ich 三方协调指南 临床研究报告的结构和内容 e3 现行第4 阶段版本 于1995 年11 月30 日发布 本指南由适用的ich 专家工作组制订，并已按照ich 程序经监管方商讨。在此 程序的第4 阶段，建议欧盟、日本和usa 监管部门采纳最终草案。

2012年6月21日 · This supplementary Questions and Answers document intends to clarify key issues which were identified since the ICH E3 Guideline was published in the three ICH Regions. The ICH E3 Q&As document is available for download from the E3 Section on the Efficacy Guideline page.

Some in the pharmaceutical industry have expressed concern that the ICH E3 Guidance, Structure and Content of Clinical Study Reports (hereafter, E3), is intended as a requirement, i.e. a template that must be followed.

ICH E3 is a Guideline, not a set of rigid requirements or a template, and flexibility is inherent in its use. “The Guideline is intended to assist sponsors in the development of a report that is complete, free from ambiguity, well organized, and easy to review.”