Drug Evaluation Committee Promotion of consistent quality management as a clinical trial ～Toward Further Collaboration between Clinical Trial Sponsors and Medical Institutions
Clinical Evaluation Subcommittee
May 2024
In TF-2 of the Clinical Evaluation Committee in FY2023, "Promotion of Consistent Quality Management as a Clinical Trial: Toward Further Collaboration between Clinical Trial Sponsors and Medical Institutions" was prepared as a reference material for sponsors and medical institutions to work on consistent quality management as a clinical trial based on mutual understanding.
The content of this document is useful for sponsors, CROs, medical institutions, SMOs, and other parties involved in clinical trials. In addition to the slides (main body and attached materials), explanatory drafts of the main body of the slides and explanatory videos are also included. Please select the format that best suits your purpose.
<Slide Structure and Summary> (Slides 1-3 below are the main body of the document)
- Promotion of consistent quality management as part of clinical trials: Toward further collaboration between sponsors and medical institutions (slide 1)
- Promotion of consistent quality management in clinical trials: Toward further collaboration between sponsors and medical institutions (explanatory note)
- Promotion of consistent quality management as a clinical trial - Toward further collaboration between sponsors and medical institutions - (explanatory video)
- Attachment_How to proceed with process-focused monitoring -Monitoring according to 4 Stages and 10 Steps
This document is composed of materials on quality management that have been published by the Clinical Evaluation Subcommittee. Please refer to the links below for details of the past documents. (Please refer to the above Appendix for "Monitoring in Consideration of Process Management at Medical Institutions" as it is not available on the website of the Pharmaceutical Manufacturers Association of Japan).
| Documents | Target audience | Summary |
|---|---|---|
|
ICH E6 (R2) Training Materials (July 2018) |
Sponsor |
Slides used in the training session for understanding the content of ICH-E6 (R2) (revised content of ICH-E6 (R2), QMS, Risk Management, Issue Management, and examples of questions to ICH-E6 (R2)) are available as training materials. |
|
How Medical Institutions Should Focus on the Changing Environment of Clinical Trials - 16 Key Points for Clinical Trial Sponsors ( September 2018) |
Medical Institutions |
From the perspective of a sponsor, the report proposes 16 key points considered necessary for an autonomous medical institution from six perspectives: "education," "roles," "staffing," "systems," "outcomes," and "culture. |
|
Start Today! Process Management of Clinical Trials Con ducted by Medical Institutions (July 2021) |
Medical Institutions |
The desirable form of process management by medical institutions is proposed as "9 steps" consisting of Risk Management and Issue Management, and a methodology that "anyone" can "correctly" and "feasibly" implement. The "9 steps" consist of Risk Management and Issue Management and a methodology that "anyone" can "correctly" and "practically" implement. |
|
Monitoring that takes into account the process management of medical institutions (October 2022)
|
Sponsor. |
The report proposes the necessary concepts, monitoring strategies, and specific ways to proceed when implementing process-focused monitoring. |
|
Sponsor |
It proposes a concept and examples of concrete measures to implement consistent quality management of clinical trials from the planning phase to the implementation phase on both the sponsor side and the medical institution side. |
We hope that this document will be of help in your efforts for consistent quality management as a clinical trial.
Japan Pharmaceutical Manufacturers Association
Committee on Drug Evaluation, Clinical Evaluation Subcommittee
2023 Task Force 2
Deliverables of the Drug Evaluation Committee Return to list of all deliverables