DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

International guidelines suggest that clinical trial data should be actively monitored to ensure data quality. Traditional on-site review is time consuming, expensive, and as is true for any manual effort, limited in scope and prone to error. In contrast, risk-based monitoring (RBM) employs centralized review of trial data to determine if sites should receive more extensive review. We demonstrate the RBM and fraud detection capabilities of JMP Clinical to assess clinical trial data quality.