EMA publishes ICH M11 (CeSHarP) for Comments

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The International Council for Harmonisation (ICH) approved the draft Guidance M11 for a harmonized electronic study protocol in clinical trials (CeSHarP) for public comment in Step 2b of the ICH process on September 27, 2022. Now, the EMA's Committee for Human Medicinal Products (CHMP) published it for information and comment in the EU on October 26, 2022. The comment period runs until February 26, 2023.

Background

The creation of the M11 Guidance was endorsed by the ICH Management Committee in November 2018. According to the ICH, the new guideline is proposed to provide a comprehensive clinical protocol organization with standardized content. The Guidance consists of three separate documents:

• The core document M11 (CeSHarP),
• A template that presents the format and structure of the protocol, 
• A technical specification that enables the interoperable electronic exchange of protocol content.

The purpose of this harmonized guideline is to ensure that protocols are created consistently and provided in a harmonized data exchange format that is acceptable to regulators. The template provides a comprehensive clinical protocol organization with standardized content including required and optional components. The technical specification, which should be accepted by all ICH member regulators, presents conformance, cardinality, and other technical attributes that enable interoperable electronic exchange of protocol content. The specifications are intended to develop an open, non-proprietary standard that enables the electronic exchange of clinical protocol information.

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