论文部分内容阅读
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。
The quality of clinical trials and the credibility of the data are not only correctness of the data analysis, but also the data quality throughout the life cycle of the trials where they are obtained and the true integrity of their data documents and their process compliance . Compliance with good clinical trial quality management standards means that the management of test data and its data files should also be truthful and complete so that the test data can be a powerful evidence of the safety and efficacy of test drugs. Therefore, the monitoring of clinical trials and their data quality can not be limited to verifying the credibility and reliability of the test data analysis. It should also include the experimental management procedures and procedures that generate these relevant data, the data document’s compliance And scientific considerations.