GUIDANCE DOCUMENT
M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol June 2025
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2022-D-3054
- Docket Number:
- FDA-2022-D-3054
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research, Office of Regulatory PolicyCenter for Biologics Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of the revised draft technical specification entitled “M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol (CeSHarP)” and a supplemental document entitled “M11 Template.” The revised draft technical specification and template were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The revised draft technical specification recommends the use of an open, nonproprietary standard to enable electronic exchange of clinical protocol information. The template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. These ICH documents create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This revised draft technical specification and updated template revise and replace the draft versions of the same titles issued in December 2022.