Annual Report 2021

Research Audit Office

Takako Kuwaki

Introduction

 The Research Audit Section conduct audits for GCP [Good Clinical Practice] trials / clinical research for clinical studies led by the NCCHE’s investigators; other activities included revision of audit procedure, GCP-related training, and consultation.

The Team and What We Do

 For clinical studies led by the NCC’s investigators, audits were conducted on GCP trials and clinical research. Other activities included revision of audit procedure, providing GCP-related training, and consultation. GCP-related training utilized an eLearning system, and GCP Training Certification was issued to each staff member after a training test. In addition, the serious issues/deviations were reported to the NCCHE Clinical Research Management Committee, and we supported creating the hospital’s preventive action plan, including providing training.

 In 2021, an application was submitted for manufacturing approval to expand efficacy using one of our investigator-initiated clinical trials. An inspection support team consisting of relevant staff members was established for this application led by the Research Audit Section. The Research Audit Section led the inspection support team and coordinated the inspection by the regulatory authority, including preparing/creating the documentation and preparing the responses. In addition, we held discussions with the applicants and regulatory authority.

Research activities

 Continue to support clinical research departments to improve the quality of clinical trials by implementing GCP-related training and through the audits.

Future Prospects

 Continue to support clinical research departments to improve the quality of clinical trials by implementing GCP-related training and through the audits. In addition, continue to consider audit techniques for efficient evaluation.

 The development and improvement of our quality management system will be continued to support clinical research.