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Risk Index Calculator

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.

It is an open-source software distributed under the terms of the GNU Affero General Public License.
This download includes a User Manual that describes the different functionalities of the application and presents the quality management model in which the RI Calculator is used.
Other documents templates related to the implementation of a quality management model can be provided on demand including:
    • A RI Calculator validation plan and associated validation scripts
    • An Integrated Quality Risk Management Plan (IQRMP) template
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