Research Audit Section

  Hidekazu Arai, Atsushi Okazaki

Introduction

 Our mission is to contribute to the maintenance and improvement of the quality of clinical research conducted at the National Cancer Center. We are sharing information regarding audits conducted at the Tsukiji Campus and Kashiwa Campus.

The Team and What We Do

• Clinical Research: 10

 Regarding the reporting of audit results, we reported general summary reports to President of the National Cancer Center, 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.

 When necessary, the operations and standard operating procedures will be reviewed and revised in consultation with the Research Audit Office at the Kashiwa Campus and other related organizations.