Drug Evaluation Committee Common Templates for Explanatory and Consent Documents (ICF)
Clinical Evaluation Subcommittee
November 2025
The preparation of the explanatory documents used in clinical trials is the responsibility of the investigator. The sponsor provides the investigator with an ICF form that includes the necessary information for each clinical trial. This form is unique to each sponsor, and in many cases, medical institutions also stipulate their own forms. This places a heavy burden on both the medical institution and the sponsor in creating and checking the ICF, and is one of the inefficient factors in the Japanese clinical trial environment. Another issue is that this results in different information being provided to trial participants at different medical institutions, even for the same clinical trial.
Against this background, the Clinical Evaluation Subcommittee of the Committee on Drug Evaluation of the Japan Pharmaceutical Manufacturers Association (JPMA) has developed a common ICF template based on the Common ICF template Version 1.1 published by the R&D Head Club, with input from medical institutions, patient groups, lawyers and others.
This Common ICF Template is to be used in common throughout Japan without compromising the significance of the Common ICF Template, and to ensure uniformity of information for clinical trial participants, by making the overall structure and general explanatory items regarding the clinical trial unchangeable, and by setting certain rules for describing the content specific to the clinical trial. The purpose is to reduce the burden on both medical institutions and sponsors in preparing, reviewing, and explaining ICFs.
We hope that all parties concerned will understand the significance of introducing a common ICF template in Japan for all sponsors and medical institutions, and we urge all parties concerned to proceed with the introduction of this common ICF template.
In order to promote drug development without lagging behind overseas countries, it is necessary to establish an internationally accepted clinical trial implementation system and environment, and the widespread use of the common ICF template by Japanese sponsors and medical institutions will enable participants in clinical trials to receive the same information and make decisions on participation in clinical trials, We hope that this will improve efficiency by reducing the burden in the preparation and review of ICFs, maintain the environment in which Japan is selected as a country to conduct global clinical trials, and help lead to the prompt provision of new drugs to patients.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation, Clinical Evaluation Subcommittee
Special Project 3
Common Template for Explanatory and Consent Documents (ICF) (Version 1.2)
Explanatory and Consent Document (ICF) Change Comparison Chart
Notice of Revision of the "Common Template for Explanatory and Consent Documents (ICF) (Version 1.2)
Common Template for Explanatory and Consent Documents (ICF) Explanatory Materials
Q&A on the Common Template for Explanatory and Consent Documents (ICF)
Common Template for Explanatory and Consent Documents (ICF) Educational Pamphlet
The Ministry of Health, Labour and Welfare (MHLW) has issued a "Request for the Use of Common Forms for Explanatory Documents and Consent Documents in Clinical Trials (Medical Affairs Bureau, No. 0704-1, Pharmaceutical Affairs Bureau, No. 0704-2, July 4, 2024)" regarding the active use of ICF common templates.
Names of companies that have implemented the ICF common template are now available (scheduled to be available until the end of March 2027).
| Names of companies that have already introduced the ICF (in alphabetical order) |
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Asahi Kasei Pharma, Asuka Pharmaceutical, Astellas, AstraZeneca, AbbVie, Amgen, EA Pharma, Eisai, MSD, Otsuka Pharmaceutical, Ono Pharmaceutical, Kissei Pharmaceutical, Kyorin Pharmaceutical Ltd., GlaxoSmithKline K.K., Sanofi K.K., Shionogi & Co. Ltd., Teijin Pharma Limited, Toa Eiyo Co. Ltd., Bristol-Myers Squibb K.K., Maruishi Pharmaceutical Co. |
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As of December 2023Of the companies that have already introduced the system, only those that are members of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and have agreed to make their websites available to the public are listed. The number of companies that have already introduced the system is 45 (as of November 6, 2025).
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As of December 2023If there are multiple templates depending on the characteristics of the study, a company is considered to have "implemented" the ICF Common Template if one of them stipulates the use of the ICF Common Template. It does not indicate that the ICF Common Template is used for all tests.
Reference English translation
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