Issue Date: May 20, 2026
Issued by: Center for Drug Evaluation and Research,Office of Regulatory Policy
Topic(s): ICH-Multidisciplinary
Status: Final
M11 Clinical Electronic Structured Harmonised Protocol
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.M11 Template (PDF)Technical Specification Document (PDF)
Download the Guidance Document
