ICH publishes guideline M11 proposing a harmonized model for test protocols

The International Council for Harmonization (ICH) has released draft guidelines that outline a harmonized template for clinical trial protocols to promote consistency in reporting between sponsors.

The draft guidelines, along with the template and template specifications, were approved by the ICH Assembly on September 27 and released for public comment on October 21.

The guideline aims to have clinical trial protocol templates that are “complete, unambiguous, well-organized and aligned with quality-by-design principles as set out in other ICH guidelines.”

The guideline notes that “variability in the basic format and content” of clinical trial protocols “contributes to inefficiencies and difficulties in searching, reviewing, and evaluating clinical trial protocols.”

Clinical trial protocols describe the processes and procedures governing the conduct of clinical trials. The guideline states that “to date, no internationally adopted harmonized standard has been established for the format and content of the clinical trial protocol to support consistency between sponsors and for the electronic exchange of ‘protocol information’.

Compliance with this model and the technical specifications would promote a “harmonised data interchange format acceptable to regulatory authorities”.

The model and specifications apply to clinical trials in all areas of clinical research and include human, exploratory, confirmatory, and post-approval pharmaceutical studies.

The model contains a set of basic information for clinical trials called “Clinical Electronic Structured Harmonized Protocol (CeSHarP)”. It covers fonts that should be used in protocols, numbering of tables and figures, and acceptable abbreviations. It also includes a draft protocol.

Technical specifications describe structured content components, such as specific data fields. The specifications are designed to promote structured common core content, define content specifications for electronic interchange, and use an open, non-proprietary interchange message standard.

This topic was approved by the ICH Management Committee in November 2018.

ICH M11 guideline



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