Annual Report 2018

Research Audit Section

Hidekazu Arai, Atsushi Okazaki, Teruhiko Yoshida

Introduction

 The Research Audit Section was established in January 2017. Two experienced staff of our section perform audits to assure the reliability and integrity of clinical studies planned and performed by the staff of the National Cancer Center Hospital (NCCH).

The Team and What We Do

 During the period from April 2018 to March 2019, three audits were conducted on investigator initiated clinical trials, six audits on the study performed in accordance with the Japanese Advanced Medical Care B program, and five audits on other clinical studies.

Education

 Our section has provided Good Clinical Practice (GCP) training courses for the staff of the NCCH. Our section staff, in turn, have participated in various training seminars in the NCCH.

Future prospects

 Our section will continue to contribute to improving the quality of clinical studies such as GCP trials and advanced medical B trials, through audits and related work.

 In addition, our section has prepared an audit procedure for "Specified Clinical Trials" associated with the enforcement of the "Clinical Trial Act". Audits will be conducted by request from the investigators.