刘川, 韩秀兰, 孙华龙, 代囡. 临床试验及其数据质量管理的国际观点J. 药学学报, 2015,50(11): 1434-1442.
引用本文: 刘川, 韩秀兰, 孙华龙, 代囡. 临床试验及其数据质量管理的国际观点J. 药学学报, 2015,50(11): 1434-1442.
LIU Daniel, HAN Xiu-lan, SUN Hua-long, DAI Nan. Global views on clinical trials and data qualityJ. Acta Pharmaceutica Sinica, 2015,50(11): 1434-1442.
Citation: LIU Daniel, HAN Xiu-lan, SUN Hua-long, DAI Nan. Global views on clinical trials and data qualityJ. Acta Pharmaceutica Sinica, 2015,50(11): 1434-1442.

临床试验及其数据质量管理的国际观点

Global views on clinical trials and data quality

  • 摘要: 临床试验质量和数据可信性不仅只是数据结果分析的正确性, 还涉及到获得这些试验结果的试验全生命周期中的数据质量及其数据文档的真实完整性, 和获得它们的过程合规性。遵循良好临床试验质量管理规范标准意味着试验数据及其数据文件的管理也应当做到真实完整, 这样才能使试验数据成为验证试验药物安全有效的有力证据。所以, 对临床试验及其数据质量的监查不能只停留在试验数据分析的可信性和可靠性的验证上, 还应当包括产生这些相关数据的试验管理过程和规程、数据文档的合规性和科学性的考量上。

     

    Abstract: The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.

     

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