刘红霞, 吕映华, 周茂生, 孟庆恒, 陈君超, 何迎春, 郑青山. 基于EDC的临床试验数据质量控制J. 药学学报, 2015,50(11): 1470-1473.
引用本文: 刘红霞, 吕映华, 周茂生, 孟庆恒, 陈君超, 何迎春, 郑青山. 基于EDC的临床试验数据质量控制J. 药学学报, 2015,50(11): 1470-1473.
LIU Hong-xia, LV Ying-hua, ZHOU Mao-sheng, MENG Qing-heng, CHEN Jun-chao, HE Ying-chun, ZHENG Qing-shan. Quality control of clinical data management based on EDCJ. Acta Pharmaceutica Sinica, 2015,50(11): 1470-1473.
Citation: LIU Hong-xia, LV Ying-hua, ZHOU Mao-sheng, MENG Qing-heng, CHEN Jun-chao, HE Ying-chun, ZHENG Qing-shan. Quality control of clinical data management based on EDCJ. Acta Pharmaceutica Sinica, 2015,50(11): 1470-1473.

基于EDC的临床试验数据质量控制

Quality control of clinical data management based on EDC

  • 摘要: 随着电子化数据管理 (EDC) 的广泛应用, 数据管理模式正在发生转变。为充分认识EDC的优势, 本文选择20个代表性注册临床试验项目, 其总样本量为5 404例, 321个研究中心, 深入分析EDC在临床试验数据管理过程中的作用, 包括在数据采集、数据清理、数据质量控制及临床试验决策等方面的优势和特点, 以期为EDC的选择提供参考。

     

    Abstract: With the wide application of electronic data management (EDC), the data management is shifting to a new mode. In order to recognize the advantages of EDC, we choose 20 representative registered clinical trials, which involve 5 404 subjects and 321 sites. We found that EDC has many beneficial impacts on the course of clinical trial data management, including the process of data collection, data cleaning, data quality control and clinical trial decision-making. The result also provides a reference for the adoption of EDC in clinical trials.

     

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