ICH M11 clinical electronic structured harmonised protocol final guidance
FDA issues final ICH M11 guidance for harmonised digital clinical trial protocol content and exchange.
What this means
The International Council for Harmonisation has finalized a new standard for designing and sharing digital clinical trial plans. Today the FDA published the final guidance, template, and technical specifications for this harmonized electronic protocol format. This means drug developers worldwide can now use a single, structured digital format for their trial protocols, which should make regulatory reviews and data sharing between countries faster and more consistent.
From the source
Docket Number: FDA-2022-D-3054
Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy
Documents in this Guidance
• M11 Clinical Electronic Structured Harmonized Protocol Final Guidance (PDF)
• M11 Template (PDF)
• M11 Technical Specification Document (PDF)
This 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.
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All written comments should be identified with this document's docket number: FDA-2022-D-3054.
Reproduced from FDA Drugs (Whats New) · view original · public domain or open-licensed government work