CDISC Standards and Clinical Research Data Standardization of Traditional Chinese Medicine

Abstract

More and more attention has been paid to the standardization of clinical research data. International clinical data standards mainly include four categories, which are the File Format, Exchange Standard, Analysis Standard and Terminology Standard. Clinical Data Interchange Standards Consortium (CDISC) is the main criteria of exchanging standard and analyzing standard currently. Backwardness of quality and level of the data management have become one of the most important factors that affect the sustained, rapid and healthy development of domestic clinical trials. How to apply international standards of clinical data to narrow the gap of clinical research of Chinese medicine with the international advanced level is a topic which needs to be continuously explored. This paper firstly introduced the CDISC and its two standards, then analyzed the significance of data standardization in clinical research of traditional Chinese medicine (TCM), and finally discussed problems existed in the process of TCM clinical research using CDISC standards. It was suggested that the strengthening on research of relevant TCM semantic structure and its terminology standard is the key problem. The only way to solve this problem is to use the CDISC standards.