M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability
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Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance includes three documents: a guidance, a template, and a technical specification document. The guidance provides the rationale and recommendations for implementing a harmonized digital clinical trial protocol. The template features standardized content structure and formatting, including headers and common text elements. The technical specification document contains harmonized terminologies and standardized data fields to enable electronic exchange of clinical protocol information. The intent of the guidance is to create an internationally harmonized standard for the content and exchange of clinical trial protocol information, facilitating the review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. This guidance finalizes the draft guidances "M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP)" issued on December 22, 2022 (87 FR 78696), and "M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol" issued on June 6, 2025 (90 FR 24146).
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