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Question:

请问源数据确认表(Source Data/Document Agreement Log)的使用有什么法规依从性风险吗?

Answer:

源数据确认表是一个工具,用于协助参与研究的各方(如试验现场研究团队人员、申办者监查员/稽查员、药品监督管理部门检查员,等)了解试验源数据的类型、来源、记录地方、格式等。可以参考2023年3月9日EMA发布的Guideline on Computerised Systems and Electronic Data in Clinical Trials Section 4.4 “The location of source documents and the associated source data they contain, should be clearly identified at all points within the data capture process.  The correct identification of source data is important for adequate source data verification and archiving.”