薬理と治療

Abstract

The introduction, dissemination and implementation of the CDISC standards in academia is important, but it has not actually progressed. It is considered meaningful for academia to build a CDISC information sharing system in collaboration with industries with abundant CDISC work experience. In order to make a“ CDISC information sharing system proposal for facilitating cooperation with industries”, we conducted a questionnaire survey targeting companies when extracting problems and issues and proposing solutions. We received suggestions on the company’s CDISC standard compliance work, ARO’s work scope and system construction related to the support, and it was recommended to cooperate with companies by holding seminars（training sessions etc.）and providing materials and information. It is interesting that some companies think the collaboration with AROs has the advantages of reducing the burden on the company and saving the creation time and cost, which may lead to the formulation of a collaboration model between the company and ARO in creating CDISC compliant data.