审计跟踪在Ⅰ期临床研究分析检测中的应用与思考

Application and thinking of audit trail in analysis of phase Ⅰ clinical trials

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 that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the course of such details relating to the electronic record. This paper introduces the role and importance of tracking audit in drug clinical trial research, The problems found in the implementation of the audit trail were discussed by case analysis. We put forward further thinking about the disadvantage of audit trail and the corresponding opinions.