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Risk-Based Monitoring (RBM) Score Calculator

Monitoring is an essential part of quality management in clinical trials. According to good clinical practice (GCP) and the latest developments in the reg­ulatory environment, risk-based approaches in clinical trials worldwide are encouraged so that limited resources are used efficiently. The Risk-Based Monitoring (RBM) Score Calculator enables you to determine the recommended monitoring strategy for your clinical trial using a simple web-based questionnaire.

Use limited resources more efficiently with the RBM Score Calculator

What it is:

The Risk-Based Monitoring (RBM) Score Calculator is a web-based questionnaire that helps you identify the best monitoring strategy for your clinical trial.

What it can do:

The web app guides you through all the relevant information. At the end of the process, the app indicates which risk category (low, medium, or high) applies to your trial and allows you to download your data as a PDF report. Your monitors can use this report to identify the actions recommended for your risk category. Alternatively, you can use our Guidelines for Risk-Based Monitoring to find the recommended actions.

Who should use it:

This tool is for sponsors and sponsor-investigators planning the monitoring of a clinical trial.

Who is behind this resource:

This calculator was developed by the SCTO’s Monitoring Platform and first published in June 2019. The easy-to-use web app was developed with support from the Statistics and Methodology Platform and was first released in January 2022.

Access

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