Drug Evaluation Committee Start Today! Process Management of Clinical Trials at Medical Institutions
Clinical Evaluation Subcommittee
July 2021
The FY2020 Clinical Evaluation Subcommittee TF-2 developed "Starting Today! Process Management of Clinical Trials at Medical Institutions" (hereinafter referred to as "TF-2") as a reference material for medical institutions to address process management in clinical trials! Process Management of Clinical Trials Conducted at Medical Institutions" (hereinafter referred to as "this document").
In this document, 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 book is proposed as "9 steps" consisting of Risk Management and Issue Management and a methodology that "anyone" can "correctly" and "practically" implement.
This document consists of two main bodies and four appendices.
Two versions of the main body have been prepared: (1) a Word version, in which the proposal is explained in slides plus text, and (2) a Power Point version, in which the proposal is summarized on slides. Please use these versions as appropriate depending on the situation of your medical institution.
Attachments include a case study based on a hypothetical study protocol (Attachment 1) and practical tools (Attachments 2-4) that can be used in actual practice to help medical institutions visualize the proposal in practical terms.
This document is intended to enable all medical institutions to engage in process management in clinical trials. Since we believe that sponsors also need to improve their process management efforts, we hope that not only medical institutions but also sponsors will use this document as a reference.
In order for medical institutions to engage in process management, it is important for medical institutions and sponsors to cooperate with each other and fulfill their respective roles in a responsible manner.
We hope that this document will help to promote process management at medical institutions and help to maintain and improve Japan's international competitiveness.
- Process Management in Medical Institutions_Body 1 (5.4MB)
- Process Management in Medical Institutions_Body 2（3.9MB)
- Attachment 1_Case Study (4.8MB)
- Attachment 2_Process Construction Flowchart (128KB)
- Attachment 3_Draft Explanatory Material for Medical Institutions on Process Management (1.3MB)
- Attachment 4_Issue tracking log（58KB)