于永沛, 姚晨. 数据盲态核查对数据质量的作用J. 药学学报, 2015,50(11): 1498-1501.
引用本文: 于永沛, 姚晨. 数据盲态核查对数据质量的作用J. 药学学报, 2015,50(11): 1498-1501.
YU Yong-pei, YAO Chen. Data quality in clinical trials: the role of blind reviewJ. Acta Pharmaceutica Sinica, 2015,50(11): 1498-1501.
Citation: YU Yong-pei, YAO Chen. Data quality in clinical trials: the role of blind reviewJ. Acta Pharmaceutica Sinica, 2015,50(11): 1498-1501.

数据盲态核查对数据质量的作用

Data quality in clinical trials: the role of blind review

  • 摘要: 盲态审核是数据管理与统计分析的衔接环节, 盲态审核对数据质量应从数据管理和统计的角度综合予以考虑。盲态审核阶段对试验数据进行最终的稽查和质量评价有助于保证经过数据管理后提交的数据能达到统计分析的质量要求; 对方案违背和/或偏离情况的分析和评价是研究结论科学可靠的必要保证, 同时也为后续的统计分析中数据质量问题的处理提供了参考。

     

    Abstract: Blind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group. Database auditing, listing data reviewing and reconciliation should become a good clinical data management practice. Statisticians, on the other hand, will focus on quality findings related to protocol deviations or protocol violations. To investigate the protocol deviations and/or violations and relevant impacts on data outcomes, it is important to provide the essential basis of data quality through the blind review, and to assess the reliability of study outcomes.

     

/

返回文章
返回