Annual Report 2022

Research Audit Section

Hidekazu Arai, Atsushi Okazaki

Introduction

 Our mission is to contribute to maintaining and improving the quality of clinical trials and studies conducted at the National Cancer Center Hospital (the NCCH). To this end, we perform audits to assure the quality of clinical trials/studies.

The Team and What We Do

 Our section has two experienced auditors. During the period from April 2022 to March 2023, we conducted six audits on investigator-initiated clinical trials and seven audits on other clinical studies.

Research Activities

 Auditing clinical trials/studies*

 *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

 The regulatory requirements for clinical trials and studies have been revised. New operations such as Decentralized Clinical Trials (DCT) are also in progress in Japan. We perform audits tailored to individual clinical trials and studies. We will revise the audit operating procedures to improve the auditing process.