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审计跟踪是记录电子数据被添加、删除或更改等细节的一个过程,可以帮助进行电子数据相关细节的重建。本文介绍了审计跟踪在Ⅰ期临床研究分析检测中的作用与重要性,通过案例研究分析,探讨了审计跟踪在实施过程中所发现的问题,进一步思考了审计跟踪的不足并提出了相应的意见。
Audit trail is a process of recording details such as the electronic data being added, deleted or changed, which can help to reconstruct the relevant details of electronic data. This paper introduces the role and importance of audit trail in the phase Ⅰ clinical research analysis and detection. Through case studies and analysis, it discusses the problems found during the implementation of audit trail, further considers the shortcomings of audit trail and puts forward corresponding opinions .