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 Webinar September "ICH E6 (R3) Annex 2"

Join us for a discussion on CH E6 (R3) Annex 2 and its role in modernizing GCP to better reflect the evolving landscape of clinical research on Wednesday, September 9, 2026.

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