Risk Index Calculator
The Risk Index (RI) Calculator is a Microsoft Excel application designed to generate study-specific analytics for the centralized statistical monitoring of investigational sites as part of a clinical trial risk management process.
The RI calculator namely uses periodically imported datasets to compute Key Risk Indicators (KRI) metrics that guide the implementation of risk mitigation actions. Metrics can also be used to plan site visits and set source data verification (SDV) requirements in accordance with a Risk-Based Monitoring approach. Reports can be periodically generated with the RI Calculator to ensure the traceability of the clinical trial risk management process.
- A RI Calculator validation plan and associated validation scripts
- An Integrated Quality Risk Management Plan (IQRMP) template