Systematic Risk Assessment for Risk-Based Monitoring

Identification of Key Risk Indicators and Thresholds

What are Key Risk Indicators?

Key Risk Indicators (KRIs) are metrics that are identified during the Systematic Risk Assessment of the clinical study process. These KRIs are used to track the status of critical processes and data which were identified by a score-based prioritization. If the metric of this dynamic risk exceeds certain predefined thresholds, corrective actions are triggered to rapidly mitigate the risk.