Annual Report 2018

Research Audit Section

Takako Kuwaki

Introduction

 The Research Audit Section conduct audits for GCP (Good Clinical Practice) trials/ B-type advanced medical service 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, eight audits were conducted on GCP (Good Clinical Practice) trials, and two audits on clinical research. Other activities included revision of audit procedure, GCP-related training and consultation. GCP-related training utilized an eLearning system. In addition, the issue management process flow was clarified and developed a tracking tool.

Clinical trials

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

Education

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

Future prospects

 An additional audit procedure should be developed for specified clinical trial under the Clinical Trials Act; the audit will be conducted by requests of researchers. Considering the expected increase of the requests, introduction of the riskbased audit plan will be effective for improving our research process. The development and improvement of our quality management system will be continued to support clinical research.