Annual Report 2021

Research Audit Section

Hidekazu Arai, Atsushi Okazaki

Introduction

 Our mission is to contribute to maintaining and improving the quality of clinical trials/studies conducted at the National Cancer Center Hospital (the NCCH). To that 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 2021 to March 2022, seven audits were conducted on investigator-initiated clinical trials, and fifteen were performed 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 has provided Good Clinical Practice (GCP) training courses for the 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/studies have been revised. We perform audits tailored to individual clinical trials/studies. For example, we are required to conduct audits as part of our quality management system.