Drug Evaluation Committee Event for medical institutions "Symposium on Promoting the Use of ICF Common Template: Case Studies of its Introduction in Medical Institutions" (Web-based event: Feb. 26, 2025)
Apr 03, 2025
On February 26, 2025, the Clinical Evaluation Subcommittee of the Committee on Drug Evaluation of the Japan Pharmaceutical Manufacturers Association (JPMA) held a symposium titled "Symposium for Promotion of ICF Common Template Utilization: Examples of Introduction at Medical Institutions" for medical institutions involved in ICF, with the aim of promoting the introduction and utilization of the "ICF Common Template". The symposium was held to promote the introduction and utilization of the "ICF Common Template" for medical institutions involved in ICF. The symposium introduced the background of the standardization of the "ICF Common Template," the use of the "ICF Common Template," and actual examples of its use by medical institutions that have experience in its use. The panel discussion included medical institutions, the Ministry of Health, Labour and Welfare, sponsors, and others. During the panel discussion, there was a lively exchange of opinions on the necessity of promoting the introduction of the template from the sponsor side, improving the quality of the contents of Section C, which is the study-specific part of the template, and explaining the significance of the template and the policy for its use to IRB members.
Agenda of the day
- Opening Remarks (Japan Pharmaceutical Manufacturers Association)
- Significance of ICF Common Template and Further Efficiency of Clinical Trials (Ministry of Health, Labour and Welfare)
- Background of the creation of the ICF common template and how to use it (Japan Pharmaceutical Manufacturers Association)
- Examples of introduction of ICF common template and advantages of its use (①) (Medical institutions ①)
- Examples of introduction of common ICF templates and advantages of their use (2) (Medical institution ②)
- Examples of introduction of the ICF common template and advantages of its use (3) (Medical institution 3)
- Panel Discussion
- Closing Remarks (Japan Pharmaceutical Manufacturers Association)
The recording of this symposium can be viewed at the following link.
-
As of December 2023
The symposium recording and presentation materials may not be quoted, reprinted, reproduced, provided to a third party, or modified without permission.
The common ICF template should be widely used by sponsors and medical institutions so that participants in clinical trials can receive the same information and make the same decision to participate in a clinical trial. We hope that both sponsors and medical institutions will understand the significance of the introduction of the ICF common template, and that all related parties will make the best use of it. We hope that both sponsors and medical institutions will understand the significance of the introduction of the ICF common template, and we would like to ask all related parties to please promote the introduction of the ICF common template.
Special Project 3 (TP-3), Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (JPMA)