Annual Report 2020

Research Audit Section

Takako Kuwaki

Introduction

 The Research Audit Section conducts audits for GCP (Good Clinical Practice) trials/clinical research for clinical studies led by the NCCHE’s investigators, and other internal audit which are independent of quality functions. The audits are to evaluate trial conduct and compliance with the GCP.

The Team and What We Do

 For clinical studies led by the NCC’s investigators, audits were conducted on GCP (Good Clinical Practice) trials and on clinical research/trial. Other activities included revision of audit procedure, GCP-related training and consultation. The GCP-related training was provided using an eLearning system. In addition, we clarified the issue management process flow, developed a tracking tool, and reviewed the CAPAs.

Research activities

 We have continued to support clinical research departments in order to improve the quality of clinical trials by implementing GCP-related training and conducting audits.

Future Prospects

 We will continue to support clinical research departments in order to improve the quality of clinical trials by implementing GCP-related training and conducting audits. In addition, we will continue to consider audit techniques for efficient evaluation.

 The development and improvement of our quality management system will be continued to support clinical research.