Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection

Clin Trials: December 2, 2013

Background Site monitoring and source document verification account for 15%‒30% of clinical trial costs. An alternative is to streamline site monitoring to focus on correcting trial-specific risks identified by central data monitoring. This risk-based approach could preserve or even improve the quality of clinical trial data and human subject protection compared to site monitoring focused primarily on source document verification.

Purpose To determine whether a central review by statisticians using data submitted to the Food and Drug Administration (FDA) by clinical trial sponsors can identify problem sites and trials that failed FDA site inspections. Read More