基于临床数据获取协调标准的中医药临床试验病例报告表设计

Design of Case Report Form for Traditional Chinese Medicine Clinical Trials Based on Clinical Data Acquisition Standards Harmonization

目的探讨基于临床数据获取协调标准(CDASH)的中医药临床试验病例报告表(CRF)的设计原则、方法及内容。方法对照最新版CDASH v 2.0,结合中医药临床试验数据特点,设计符合中医药临床试验实际需求的标准化CRF。结果将CDASH引入中医药临床试验CRF的设计中,规范中医药临床试验数据采集字段和变量,达到CRF设计的标准化,提高数据质量的目的。结论执行CDASH进行中医药临床试验CRF设计,可以促进中医药临床研究数据的交换与共享。

Objective,CDASH. Methods According to CDASH v2.0 and characteristics of TCM clinical trial data,a standardized CRF which meet the actual needs of TCM clinical trials was designed. Results The application of CDASH in designing of CRF for TCM clinical trials is helpful for standardizing the data collection fields and variables, achieving the standardization of CRF design and improving data quality. Conclusion Implementing CDASH into design of CRF for TCM clinical trials can promote exchanging and sharing TCM clinical research data worldwide.