Current Edition

Centralised ECG Monitoring and its Role in Clinical Trials

Electrocardiogram (ECG) data collection and monitoring constitutes an integral part of the safety evaluation of any new drug in all phases of clinical trials. The widespread adoption of the ICH E14 guidance, following its implementation in 2005, has brought into focus the important role played by central ECG labs in collecting high-quality cardiac safety data that meet regulatory requirements. This paper by Gopi krishna Panicker, J. Rick Turner and Snehal N kothari, of Quintiles, reviews the activities related to ECG monitoring for clinical trials in general, the gaps and overlaps in its workflow and how centralised ECG monitoring streamlines this workflow, and the current scenarios where centralised ECG monitoring is essential.