薬理と治療

Abstract

Sharing clinical research data is essential for the development of medicine, and the introduction of CDISC standards in academia is expected for that purpose. However, few academia have introduced the CDISC standards. The first barrier to the introduction of the CDISC standard is that it is difficult to correctly correspond the variables defined in the CDISC standard to the input items on the case report form. To overcome this obstacle, we have created a portal site on the Internet to collect and put case report forms annotated with the CDISC variables used in existing clinical studies. Anyone can freely view and use the annotated case report forms. So far, annotated case report forms from eight existing clinical studies have been put on the website as of April 2021. By imitating these case report reports, it is expected that the introduction of CDISC in academia will be promoted.