EDC越来越普及,法规也越来越关注数据的完整性,而审计追踪(audit trail)可以记录电子数据相关的who、what、when、why,是一种非常重要的工具。 本文概述了一种行业观点,就是如何最大限度地提高实施有针对性的、常规的审计追踪审核(audit trail review, ATR)的价值。提供了基于风险的ATR的建议,以及何时使用可视化技术和...
审计追踪审核（ATR）作为确保数据完整性的关键工具，已成为行业内的共识。本篇论文由eClinical Forum和SCDM合作撰写，旨在提供实现对大型审计追踪数据集进行针对性例行审核价值的行业观点。文章提出了基于风险的ATR用例建议和相应的报告标准，以及关于何时使用可视化和异常报告生成关键、可操作见解的建议。此外，...
临床研究领域正以快速的步伐发展,特别是随着适应性设计、eSource解决方案的引入以及各种新的数据采集方法的兴起,确保数据的完整性与可靠性变得尤为重要。审计追踪审核 (ATR) 作为确保数据完整性的关键工具,在这个过程中扮演着核心角色。本文旨在概述如何最大限度地实现对审计追踪数据集的有针对性的例行审核,为ATR的基于...
谈到常用短语，我们不得不提“audit trail”和“audit report”。前者指的是“审计轨迹”，即记录审计过...
Bertini, RobertoBlume, FlorianBrown, StevenBudimir, ChristophJung, DirkKühn, MichaelHrmeyer, HelmutMalordy, UlrikeMensch, IrisScheidl, ChristianPharmazeutische Industrie (Pharmind)
英文:The system should be able to generate detailed audit trail reports for future review and analysis. 英文同义表达: Audit log(审计日志):这是另一种说法,主要强调记录审计信息的日志或文件。 Audit record(审计记录):这个短语侧重于每次审计活动或交易后留下的具体记录。 Audit t...
The newest release of OpenLab CDS is the only CDS that allows electronic review of the audit trail and its associated records, together. Other systems require the user to print out and sign audit trail reviews. Figure 1 The OpenLab CDS audit trail is focused on the record being reviewed, ...
data acquisition, audit trail review, versioning data, data retention, data availability, data retrieval, regulations, data security, third party instrument control, multi- vendor control Summary Audit Trails are an important regulatory requirement and are a proven effective means of detecting data integ...
Use audit trail to identify Product Hub business objects that you want to track for data changes and object definition changes.
英文: Review daily Audit Trail Report.中文: 检查每日的稽核报告。英文: Who keeps an audit trail?中文: 谁来检查跟踪?英文: Record the audit outcome and send audit report.中文: 记录稽查结果并发出稽查报告。英文: This article has emphatically summarized the audit function, the audit goal, the ...