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) .

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.

2024年12月11日 · 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 ...

Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process.