In this article, a new TCM clinical trial of phaseⅢ was served as an example of application of Clinical Data Interchange Standards Consortium (CDISC). It briefly introduced seven data acquisition modules commonly used in clinical research of new traditional Chinese medicine, namely demographics, subject characteristic, clinical event, medical history, questionnaire, laboratory inspection and adverse event. It also introduced the process of transferring the above modules to Study Data Tabulation Models (STDM), and discussed the feasibility and some issues that required attention of CDISC application in clinical research of new traditional Chinese medicine.%以一个中药新药Ⅲ期临床研究为例，简要介绍在数据库中构建人口统计学、受试者特征、临床事件、病史、量表、实验室检查、不良事件等7个中药新药临床研究中常用的数据采集模块，以及将其转换到研究数据表格模型（SDTM）的过程，探讨临床数据交换标准协会（CDISC）临床数据交换标准在中药新药临床研究中应用的可行性和需要注意的问题。
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