Annual Report 2019

Research Audit Section

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, 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 we developed a tracking tool.

Research activities

 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

 Continue to support clinical research departments in order 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.