张新佶, 于浩, 魏朝晖, 贺佳. 临床数据管理中的统计学监查J. 药学学报, 2015,50(11): 1425-1427.
引用本文: 张新佶, 于浩, 魏朝晖, 贺佳. 临床数据管理中的统计学监查J. 药学学报, 2015,50(11): 1425-1427.
ZHANG Xin-ji, YU Hao, WEI Zhao-hui, HE Jia. Quality control of statistical analysis in data management of clinical trialsJ. Acta Pharmaceutica Sinica, 2015,50(11): 1425-1427.
Citation: ZHANG Xin-ji, YU Hao, WEI Zhao-hui, HE Jia. Quality control of statistical analysis in data management of clinical trialsJ. Acta Pharmaceutica Sinica, 2015,50(11): 1425-1427.

临床数据管理中的统计学监查

Quality control of statistical analysis in data management of clinical trials

  • 摘要: 数据是临床研究的基础和生命, 临床研究需要严格、标准、规范的数据管理。其整个生命周期需要贯穿统计学监查的思想。本文简要介绍了临床研究数据管理中统计学监查的目的、内容、方法与形式, 为临床研究数据管理中统计学监查工作的顺利开展提供支持和依据。

     

    Abstract: Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.

     

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