Drug Evaluation Committee Ensuring Effective and Efficient Quality in Clinical Trials Based on the Quality by Design Concept - Toward Consistent Quality Management from Planning to Implementation
Clinical Evaluation Subcommittee
July 2023
In TF-2 of the Clinical Evaluation Subcommittee in FY2022, the Committee discussed the "Ensuring Effective and Efficient Quality in Clinical Trials Based on the Concept of Quality by Design" with the aim of protecting the human rights, maintaining the safety and improving the welfare of participants (subjects) and ensuring the quality of clinical trials effectively and efficiently by planning clinical trials based on an understanding of the concept of quality by design. Ensuring Effective and Efficient Quality in Clinical Trials Based on the Quality by Design Concept: Aiming for Consistent Quality Management from Planning to Implementation" (hereinafter referred to as "this document").
This document 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, in the following structure.
Chapter 1:
- Trends in GCP Renovation
- Past activities of the Clinical Evaluation Subcommittee and issues addressed in this document
Chapter 2:
- Important concepts in understanding quality by design (fitness for purpose, critical factors for quality, risk-based approach)
Chapter 3:
- Concept of quality by design for clinical trials
- Quality management of clinical trials from planning to implementation
Chapter 4:
- Specific measures to implement consistent quality management of clinical trials
Columns (information that will be helpful in reading this document):
- Basic concepts of QMS (process approach, PDCA cycle, risk-based approach)
- Purpose and quality of clinical trials
The main target readers of this book are assumed to be those who are involved in the planning of clinical trials on the sponsor side and those who are in charge of monitoring the implementation of clinical trials, as well as those who are in charge of the practical affairs at the medical institution side. However, since the content of this book is applicable not only to clinical trials but also to clinical trials and clinical research, it should be read widely by persons in charge of clinical trials other than those mentioned above.
Deliverables of the Drug Evaluation Committee Return to list of all deliverables