"This is the best use of my time to remain current with what is going on in the industry."
Team started in August 2024. The goal is to review, prioritize and standardize the audit trail review data checks based on the eCF ATR position paper (2021) and create a list of high impact checks that can be implemented by sponsor companies and technology vendors.
In Sep 2025, the team provided a webinar to the eCF members on their paper "Strategies for Implementing Audit Trail Review". The recording is available to eCF members in the "Members" section of this website (un/pw required). The paper was released to eCF members for a 6-month exclusive use in October 2025. The ATRA team welcomes feedback (please contact Jana.Summa@eclinicalforum.org). We anticipate releasing the paper to the public via this website sometime in 2Q 2026.
Americas Autumn Workshop, October 13-15, 2026, Bloomington IL, USA, hosted by GenInvo
APAC/Hybrid Autumn Workshop, October 22-23, 2026, Shanghai, China, hosted by Clario
Europe/Hybrid Autumn Workshop, October 27-29, 2026, Zurich, Switzerland, hosted by BSI Software
eCF Webinar November: FDA warning letters for audit trail analytics
FDA warning letters tell us what went wrong, but what could your audit trail analytics program have caught earlier? Join our upcoming webinar for a practical, in-depth look at an FDA warning letter and learn how to identify missed signals, uncover blind spots, and strengthen your audit trail review program.