Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS

2.3 Geocoding Sites

While a data table of site-level risk indicators is useful for understanding individual site performance, such a presentation fails to consider the role geography and location may play in the collected data and their interpretation. For example, perhaps environmental differences at certain locations lend themselves to an increased incidence of certain safety issues. Sites within certain areas may have received training from a particular vendor, and trial monitors may be responsible for different sites based on their location. Further, countries may have differing standards and regulatory obligations that can impact the findings of an RBM analysis and review. These details are important for understanding why the risk may be ...