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The eClinical Forum is releasing the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review".
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.
Best practices for meeting regulatory expectations for Audit Trail Review
(02/04/2026)
eCF Spring 2026 Workshops Announced!
We are happy to announce our Spring workshops!
Europe/Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well)
Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30
Asia: Hosted by Novartis in Tokyo, Japan on April 2-3