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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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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

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

The eClinical Forum is releasing the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review". 

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Registrations open for eCF Spring Workshop 2026

We are happy to announce that registrations are now open for our Spring Workshop 2026. 

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

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eCF Webinar on RBQM, ATRA, and Fit-for-Purpose Data

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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