Annual Report 2017
Research Audit Section
Takako Kuwaki
Introduction
The Research Audit section conducts audits on GCP (Good Clinical Practice) trials, B type advanced medical service trials, and clinical researches for clinical studies initiated by investigators of the National Cancer Center Hospital East (NCCHE). Other activities include revision of audit procedure, GCP-related training and consultation.
Our team and what we do
For clinical studies initiated by investigators of the National Cancer Center (NCC), eight audits were conducted on GCP trials, and two audits on clinical researches. Other activities included revision of audit procedure, GCP-related training and consultation. GCP-related training was installed as an e-Learning system. In addition, a process flow of issue management was clarified and a tracking tool was developed.
Education
We continue to support departments conducting clinical research in order to improve the quality of clinical trials by implementing GCP-
related training and through audits.
Future prospects
An additional audit procedure should be developed for a specified clinical trial under Clinical Trials Act; an audit will be conducted by request of researchers. Considering an expected increase of requests, introduction of the risk-based audit plan will be effective for the improvement in our research process. The development and improvement in a quality management system will be continued to support clinical research.