中医临床研究中电子化数据采集过程的质量控制探讨

Discussion on Quality Control of TCM Clinical Research in the Electronic Data Capture

目的探讨基于电子化数据采集的临床研究质量控制。方法根据中医临床研究项目的需求,运用SQL数据库技术建立临床研究电子化数据采集系统,使用该系统将患者随访资料录入数据库;在数据库设计、测试、实施过程中,分析电子化数据采集对于临床研究质量的影响,探讨通过电子化的数据采集系统的合理设计进行数据质量控制的方法,如逻辑核查、数据有效性检查、数据自动计算、关键指标的质量检查等。结果电子化数据采集系统的应用对于提高临床研究的数据质量具有极大的促进作用。结论有必要建立临床研究电子化数据采集系统,提高中医临床研究的数据质量。

Objective： To investigate a method for the quality control of clinical research based on electronic data capture （EDC）. Methods： According to the need of traditional Chinese medicine （TCM） clinical research project,SQL database technology was used to build clinical research electronic data capture system by which patient follow-up information was recorded into a database. During the time of design,testing, and implementation of the database, influence of electronic data capture for clinical research quality was analyzed. Some quality control methods including edit checks, data validity check, data automatic calculation, and data inspection were discussed. Results： The application of EDC could greatly promote clinical research data quality. Conclusion： It is necessary to establish the electronic data capture system for clinical research and to improve the quality of data from clinical study of TCM.