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.

Congratulations to the joint C-Path/eCF :eCOA Best Practices" Team for publishing their paper “Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes” in the peer-reviewed SCDM Journal “Digital First”. 

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.

Elected team providing strategic direction and governance.

The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites).

Maintaining the free eSRA (eSource-Readiness Assessment) questionnaire used by sites to self-evaluate electronic systems originating or managing data for clinical research.