Annual Report 2024

Research Audit Section

Hidekazu Arai, Atsushi Okazaki

Introduction

 Our mission is to contribute to the maintenance and improvement of the quality of investigator initiated clinical trials and clinical research conducted at the National Cancer Center Hospital.

The Team and What We Do

• Clinical Trials: 6
• Clinical Research: 10

 Regarding the reporting of audit results, we reported general summary reports to Director of the National Cancer Center Hospital, in addition to an individual report of each audit.

Research Activities

 Research Audit Section is independent of and separate from the conduct, support, preparation and management of clinical trials and clinical research.

Education

 The auditor conducted GCP Advance training for investigators and others at the NCC clinical research seminar. Additionally, the auditor participated in other training sessions for investigator at the National Cancer Center, striving for self-improvement.

Future Prospects

 It is necessary to keep updating auditing procedures to adapt to the revised regulatory requirements and new operations related to clinical research.