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

March 2025

The Data Science Subcommittee of the Drug Evaluation Committee’s FY2024 Task Force 4-1 is working to address challenges related to the domestic implementation of the “ICH M11 Electronically Structured and Harmonized Clinical Study Protocol (CeSHarP) (Draft).”
As part of this task force, a session titled“Challenges of Clinical Trial Digital Transformation for the Clinical Trial Ecosystem (Utilization of Protocol Data).” As part of this session, a survey was conducted targeting member companies of the Data Science Subcommittee to gather information on their current initiatives and challenges regarding the draft ICH M11 guideline, and the results were compiled.
Furthermore, since ICH M11 is intended for use not only in industry-sponsored clinical trials but also in academia-sponsored clinical trials, we conducted a survey with the cooperation of the ARO Council’s PM Experts Liaison Group to investigate the current situation in academia and raise awareness of ICH M11 through the survey.
The results of these surveys revealed the current expectations, challenges, and status of system implementation planning regarding ICH M11 in both the industry and academia. We hope this report will serve as a useful resource for promoting understanding of ICH M11 and facilitating the consideration of system implementation.

Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, Task Force 4-1, FY2024

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