Annual Report 2023

Research Audit Section

Shinya Motonaga

Introduction

 The Research Audit Section conducts audits for investigator-initiated clinical trials on Good Clinical Practice (GCP) and other regulations led by the investigators at the National Cancer Center Hospital East (NCCHE). In addition, other activities include the revision of audit procedures and providing consultation.

The Team and What We Do

 We independently established audit procedures, formulated audit plans, and conducted audits for investigator-initiated clinical trials and clinical studies planned and implemented by the physicians at the NCCHE, based on GCP and other regulations.

 In addition, we provided consultation upon request regarding tasks related to clinical trials.

 Furthermore, through auditing, we supported the clinical research departments and other relevant sections within the hospital, working to improve the quality of clinical trials.

Future Prospects

 Through audits and related activities, we will continue to support the quality improvement of investigator-initiated clinical trials and other clinical studies based on GCP and other regulations. As an independent auditing department, we will also explore auditing methods that enable more efficient evaluations and contribute to the quality improvement of more audited departments.