EMA publishes Comments on ICH M11 CeSHarP

Recommendation

5/6 June 2024

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The European Medicines Agency (EMA) published the ICH M11 (CeSHarP) draft Guideline for comments in October last year. ICH's new M11 Guideline is intended to provide a comprehensive clinical protocol organization with standardized content. The Guideline consists of the following three individual documents:

• The core Guideline M11 (CeSHarP),
• A template that presents the format and structure of the protocol, including the table of contents, common headings, and content with explanatory notes,
• A technical specification that presents the technical attributes that enable the interoperable electronic exchange of protocol content.

Following the end of comment period in February 2023, the EMA has now updated the website to include overviews of comments received on these three documents. In particular, a huge number of comments were received from organizations relating to the ICH M11 template (more than 100 pages).

More information is provided under ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline published on the EMA website.