Nicky Dodsworth on the EFGCP Workshop on Risk-Based Monitoring

In this interview with Nicky Dodsworth, we discuss the recent EFGCP Workshop on risk-based monitoring.

At the conference, speakers from industry, academia and regulators shared their perspectives on how to adapt the oversight and monitoring of a clinical trial, and of individual sites within a study, according to their risk profile relating to patient safety and the quality of resulting study data. The risk profile is based on the novelty and complexity of the study, and the capability and quality of the site performance.