"This is the best use of my time to remain current with what is going on in the industry."
The eClinical Forum is releasing the public version of its industry position paper "Audit Trail Review: Strategies for implementing Audit Trail Review".
This group will develop standard approaches, processes, expectations - generate minimum standards for us to meet the opinions of global regulators. Address the problem of generic regulations and create industry guidelines more tangible and actionable.
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.
The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial.
The joint Working Group on AI/ML by eClinical Forum and EUCROF is monitoring the evolution of AI/ML technologies in the Life Sciences domain and addressing relevant topics that are of major interest for clinical research.
Aligning the existing eCF best practices document with the most recent regulatory expectations
Best practices for meeting regulatory expectations for Audit Trail Review
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.
eCF Public Webinar March: Turning the ATRA Position Paper into Practice
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
eCF Spring 2026 Workshops Announced!
We are happy to announce our Spring workshops!
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