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随着国内临床试验电子化数据采集(EDC)应用的不断增多,既往传统的纸质数据管理模式逐渐向电子化数据管理模式转变。本文通过对14个Ⅲ期临床试验(纸质数据管理8个和EDC数据管理6个)定性和定量方面的比较研究,结果发现,与传统纸质数据管理相比,电子化数据管理在数据采集流程、数据管理效率、研究数据质量及临床试验决策等方面存在诸多优势。此外,EDC的成功实施需要相配套的数据管理流程和资源重新配置。
With the increasing use of electronic data collection (EDC) in clinical trials in China, the traditional paper data management mode has gradually shifted to the electronic data management mode. Through the qualitative and quantitative comparison of 14 Phase III clinical trials (8 paper data management and 6 EDC data management), we found that compared with the traditional paper data management, electronic data management in data acquisition Process, data management efficiency, research data quality and clinical trial decision-making and many other advantages. In addition, the successful implementation of EDC requires a coordinated data management process and resource reconfiguration.