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Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

An Industry Position Paper

Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback.  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.

This paper 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.

We’d like to thank SCDM and eClinical Forum contributors for their invaluable support in the development of this document.

For more information please contact... info@eclinicalforum.org and/or Audit Trail Review Team chair Linda King (linda.king@astellas.com)

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BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing: “Can we develop best practices for implementing standards across sponsors and CROs of all sizes to drive efficiencies that result in medical advancements getting to patients faster?”

  • Can we facilitate a mechanism to share standards across organizations to avoid process changes from one trial to the next?
  • Can we track standard utilization across organizations to be data driven about when and how updates are needed?
  • With the increase in digital trials, what additional standards should we be considering?
  • What does an optimal standards committee look like? 
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