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Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper
Jana Summa
/ Categories: Regulatory, Audit Trail Review (ATR), Visible by Public, Active, Working Group, PUBLIC DOWNLOADS, Report

Public release of "Strategies for implementing Audit Trail Review" Industry Position Paper

Public Release PR2026.1

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.

This is a significant work done by the eCF ATRA team over the past year. The team will provide a webinar to discuss the paper's practical implementations in March 2026 - if you are interested in attending, keep an eye on our "News" section or the monthly eCF Views & News Newsletter for more information 

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