Annual Report 2024

Research Audit Section

Sumio Tanabe, Mishima Toyohiro

Introduction

 The Research Audit Section is responsible for audits of investigator-initiated clinical trials based on Ministerial Ordinance on Good Clinical Practice for Drugs, audits of specified clinical research under the Clinical Research Act, and audits and internal audits of clinical research based on ethical guidelines for life science and medical research involving human subjects. It also plays a role in quality management activities related to ensuring the reliability of clinical trials and clinical research.

The Team and What We Do

 Based on the auditor appointment letter, audit plan, and audit procedures approved by the President, the Coordinating Investigator Representative, or the Principal Investigator, the auditor conducted the audit. The audit report included audit findings based on observations and recommendations for improvement that contribute to the establishment of an appropriate framework for conducting clinical trials or clinical research. Responses to the audit findings were received from the audited department, and their response status was confirmed.

Research Activities / Clinical Trials

 In fiscal year 2024, a total of 13 audit reports were issued. For investigator-initiated clinical trials, audits included 7 at implementing medical institutions, 1 audit of the coordinating investigator and the coordinating committee secretariat, and 3 audits of summary reports. For clinical research, 1 audit was conducted on the research administrative office and 1 internal audit was performed.

Education

 Regarding audit personnel, in addition to self-development through participation in research ethics seminars and internal and external training programs, monthly liaison meetings are held with the Research Audit Section of the NCC Hospital to share audit findings, including those related to non-compliance with regulatory requirements such as standard documents, thereby enhancing the competencies of audit personnel. Furthermore, discussions with audited departments help auditors understand on-site responses and perspectives, contributing to the strengthening of their knowledge and skills. For audit respondents in the audited departments, explanations are provided regarding audit findings and special notes identified during audits. These sessions serve as opportunities to reaffirm the background of regulatory requirements and the principles of quality assurance and are considered to contribute to improving the quality of clinical research.

Future Prospects

 We will continue to contribute to the development of a robust framework for conducting high-quality clinical trials and clinical research.