NEWS FROM THE ECF

Audit Trail Review Analytics (ATRA)

Audit Trail Review Analytics (ATRA)

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.

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«March 2026»
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eCF Webinar on RBQM, ATRA, and Fit-for-Purpose Data

Log in to your eCF website account to see more:

RBQM is now a requirement under ICH E6(R3). But how does it fit with other data review activities? 

The webinar is available to all our members. Date and Time: Wednesday, 25 February 2026, 14:00 UTC.

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eCF Public Webinar March: Turning the ATRA Position Paper into Practice

Log in to your eCF website account to see more:

This webinar focuses on practical implementations of the eCF industry position paper "Strategies for implementing Audit Trail Review"

The webinar is available to all our members as well as the general public. Date and Time: Thursday, 19 March 2026, 9:00 am EDT / 1:00 pm UTC. Sign up here

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