Approach to CDISC Standardization of Clinical Research Data at Clinical Research Data Center, Tohoku University Hospital

Abstract

Clinical Research Data Center, Tohoku University Hospital, has been introducing the CDISC standard into its quality management processes since FY2013. In this article, especially based on the experience of participating in the pilot project requiring CDISC Standards of PMDA, we will explain our approaches to promote the CDISC standards and also mention future issues.