Reconciling EDC & Safety Systems

In clinical trials, details of Adverse Events (AEs) and Device Malfunctions (DMs) are captured by two separate systems. The Electronic Data Capture (EDC) system captures the AE/DMs for clinical research and the safety system captures it for regulatory safety reporting.

This paper discusses the need for a robust reconciliation between these two systems. It starts by describing the problem and then describes an approach to achieve reconciliation