Annual Report 2022

Research Audit Section

Nozomu Fuse

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); other activities included revision of audit procedure, GCP-related training and consultation.

The Team and What We Do

 We formulated audit plans for investigator-initiated clinical trials on GCP and other regulations that are planned and implemented by the investigators at the NCCHE and conducted audits from an independent standpoint.

 We also planned and provided GCP-related training at the National Cancer Center and prepared an e-learning program. At the NCCHE, we conducted the post-tests for two GCP training sessions, and the director of the NCCHE issued a GCP Training Certification (valid for 3 years). We also provided the counter services for the principal investigator certification.

 In addition, we provided consultation in response to requests regarding work related to clinical trials.

 Furthermore, as part of the clinical research quality system, we reported serious deviations/inappropriate incidents that occurred in individual trials to the committees in the NCCHE and managed the progress of corrective action/preventive action (CAPA) and provided training and support as necessary.

Future Prospects

 We will continue to support the quality improvement of investigator-initiated clinical trials on GCP and other regulations through auditing and related services. Additionally, as an independent auditing department, we will contribute to improving the quality of audited departments and consider auditing methods to enable more efficient evaluation.