Drug Evaluation Committee ICH M11 "Electronically Structured and Harmonized Clinical Study Protocol (CeSHarP)" Questionnaire Results for Domestic Implementation (FY2024)

Data Science Subcommittee

March 2025

The Drug Evaluation Committee's Data Science Subcommittee Task Force 4-1 for FY2024 is working to resolve issues for the domestic implementation of the ICH M11 Electronically Structured and Harmonized Clinical Trial Protocol (CeSHarP) (draft).
This task organized a session on "Challenges of Clinical Trial DX for Clinical Trial Ecosystem (Utilization of Study Protocol Data)" as part of the 2024 DIA Japan Annual Meeting, and conducted a questionnaire survey of Data Science Subcommittee member companies to gather information on the current status and issues of each company's efforts toward the draft ICH M11 guideline. A questionnaire survey was conducted to gather information on the current status of each company's efforts and issues related to the proposed ICH M11 guidelines, and the results were summarized.
In addition, since ICH M11 is expected to be used not only in company-led clinical trials but also in academia-led clinical trials, a questionnaire survey was conducted with the cooperation of the PM Expert Liaison Group of the ARO Council for the purpose of investigating the current situation in academia and raising awareness of ICH M11 through the survey.
The results of these questionnaires revealed the current ICH M11 expectations, issues, and the status of consideration for system implementation in both companies and academia. We hope that this report will help to promote understanding of ICH M11 and to consider the introduction of the system.

Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee FY2024 Task Force 4-1

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