Introduction to the CDISC standard system and its application status

Clinical Data Interchange Standards Consortium (CDISC) is a global non-profit standard development organization. Based on the consensus of clinical research, it has established a set of standard systems, including core standards, data interchange standards, controlled terminology standards, and treatment domain standards. These standards play different roles in research and span various stages of the research process. With the development of automated software, international regulatory agencies and large pharmaceutical companies have implemented the application of CDISC standards. The standard system is gradually gaining recognition and promotion in China, and professional technical services are also being gradually developed and popularized. This article provided a detailed introduction to various standards under the CDISC standard system, including their relationships, and application processes. It summarized the application status at home and abroad and provides suggestions, aiming to provide important references for the standardization of relevant research.