尹芳, 陈君超, 刘红霞, 何迎春, 郑青山. 临床试验纸质与电子化数据管理的比较研究J. 药学学报, 2015,50(11): 1461-1463.
引用本文: 尹芳, 陈君超, 刘红霞, 何迎春, 郑青山. 临床试验纸质与电子化数据管理的比较研究J. 药学学报, 2015,50(11): 1461-1463.
YIN Fang, CHEN Jun-chao, LIU Hong-xia, HE Ying-chun, ZHENG Qing-shan. Comparison of paper and electronic data management in clinical trialsJ. Acta Pharmaceutica Sinica, 2015,50(11): 1461-1463.
Citation: YIN Fang, CHEN Jun-chao, LIU Hong-xia, HE Ying-chun, ZHENG Qing-shan. Comparison of paper and electronic data management in clinical trialsJ. Acta Pharmaceutica Sinica, 2015,50(11): 1461-1463.

临床试验纸质与电子化数据管理的比较研究

Comparison of paper and electronic data management in clinical trials

  • 摘要: 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。

     

    Abstract: Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase Ⅲ studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.

     

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