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AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY


eClinical Forum (eCF) and the Society for Clinical Data Management (SCDM)
eClinical Forum (eCF) and the Society for Clinical Data Management (SCDM)

This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of audit trails. 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.

This paper addresses the ATR process for sponsors, contract research organizations (CROs) and eClinical vendors.

View the Position Paper here

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