Annual Report 2023

Research Audit Section

Hidekazu Arai, Atsushi Okazaki

Introduction

 Our mission is to contribute to the maintenance and improvement of the quality of clinical trials and other clinical research conducted at the National Cancer Center Hospital. To this end, we perform audits to assure the quality of research including clinical trials.

 The auditors themselves make an effort to improve themselves through training and audit work organized by the Center.

The Team and What We Do

 Our section has two experienced auditors. During the period from April 2023 to March 2024, we conducted four audits on investigator-initiated clinical trials and eight audits on other clinical studies.

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

Research Activities

 The section itself does not engage in specific research but performs audits* for the following clinical trials and research in FY2023:

• Clinical trials: 4
• Specified Clinical Research under the Clinical Trials Act: 2
• Clinical Research based on the Ethical Guidelines for Medical and Biological

 Research Involving Human Subjects: 6

  *A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Education

 Our section participates in the GCP training courses for investigators and other staff of the NCCH. We also self-improve by taking the NCC training courses and/or external training in clinical trials/studies.

Future Prospects

 It is necessary to keep updating auditing procedures to adapt to the revised regulatory requirements and new operations related to clinical research. We are currently revising the standard operating procedures in consultation with the Research Audit Office at the Kashiwa Campus and related organizations.