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.

Dec 11, 2024 · ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports (PDF - 240KB)

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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..

Jun 21, 2012 · 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 …

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.”

The objective of this guidance document 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.