ICH releases M11 guideline proposing harmonized template for trial protocols
The International Council for Harmonisation (ICH) has released a draft guideline which outlines a harmonized template for clinical trial protocols to support consistent reporting among sponsors.The draft guideline, as well as the template and specifications for the template, were endorsed by the ICH Assembly on 27 September and released for public consultation on 21 October.
The guideline aims to have clinical trial protocol templates that are “complete, free from ambiguity, well organised, and aligned with quality by design principles as set forth in other ICH guidelines.”
The guideline notes that “variability in format and core content” of clinical trial protocols “contributes to inefficiencies and difficulties in searching, reviewing, and assessing 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 across sponsors and for the electronic exchange of protocol information.”
Conformance with this template and technical specifications would promote a “harmonised data exchange format acceptable to the regulatory authorities.”
Both the template and the specifications apply to clinical trials across all areas of clinical research, and include human pharmaceutical, exploratory, confirmatory, and post-approval studies.
The template has a core set of information for clinical trials called the “Clinical Electronic Structured Harmonized Protocol (CeSHarP). It covers the fonts that should be used in the protocols, numbering for tables and figures, as well as acceptable abbreviations. It also includes a draft protocol.
The technical specifications describe the structured content components, such as the specific data fields. The specifications are designed to promote structured common core content, define content specifications for electronic exchange and use an open, non-proprietary exchange message standard.
This topic was endorsed by the ICH Management Committee in November 2018.
ICH M11 guideline
Template
Specifications
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