Annual Report 2017
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 investigators of the National Cancer Center Hospital (NCCH).
Our team and what we do
During the period from January 2017 to March 2018, six audits were conducted on investigator initiated clinical trials, one audit on the study performed in accordance with the Japanese Advanced Medical Care B program, and four 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 the various training seminars in the NCCH.
Future prospects
Audits have been conducted by request from investigators for clinical interventional studies involving invasive procedures for research subjects in accordance with the "Ethical Guidelines for Medical and Health Research Involving Human Subjects". In addition, Clinical Research Act was enacted on April 14, 2017, and audits shall be performed for Specified Clinical Trials when necessary. Our section will revise its procedures to respond to audit requests by investigators. Considering the expected increase in the demand, the risk-based audit planning may be required.