RBQMLive On-Demand: Enhancing Data Quality through Advanced Audit Trail Review

Featuring: Paola Peshkepija, Senior Associate Central Monitor, Pfizer; Jennifer Nielsen, Senior Specialist, Clinical Data Management, Lundbeck

As regulatory expectations around data integrity continue to rise, audit trail review (ATR) has become essential for ensuring oversight, transparency, and confidence in clinical trial data. Once a niche, retrospective task, ATR is quickly evolving into a proactive, risk-based practice central to modern quality management.

Experts from Pfizer and Lundbeck join CluePoints to clarify what ATR truly involves, how emerging definitions are shaping industry adoption, and the practical challenges and opportunities teams face when implementing ATR across EDC, eCOA, ePRO, and other digital systems.

The discussion explores key definitions from the EMA, MHRA, and ICH E6(R3), provides real-world examples of issues uncovered through ATR, highlights the differences between system-level and trial-level reviews, and examines the operational realities of accessing, processing, and analyzing audit trail data in today’s clinical trials.