AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY

In clinical research, data integrity is paramount, and the importance of the right policies, procedures, responsibilities, and governance cannot be overstated. With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool. This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights. It contains practical implementation guidance, covering the people, processes and technology needed to execute ATRs effectively. The authors also take a deep dive into the technical aspects of what constitutes an audit trail, and how collecting and preparing audit trail data is fundamental to successful ATR capability. As an industry, we are at the start of our routine ATR journey. At the eClinical Forum and SCDM, we recognize the need to learn, adjust, and contribute to a continued dialog on this topic. Key words: audit trail, audit trail review, system access, use cases, visualizations

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