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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".
Since the publication of the 2021 position paper, the eClinical Forum has received requests for further guidance on implementing Audit Trail Review (ATR) strategies. ICH E6(R3) has called out the need for planned review of audit trail data. In response, this paper offers a structured and actionable framework to help organizations prioritize, operationalize, and scale their audit trail review activities. This publication marks an important advancement in how audit trail review is understood and operationalized within the context of ICH E6(R3), and focuses on three domains - Clinical Relevance, Data-Enabled Analytics, and Operational Integration.