Risk-Based Monitoring with adaptive strategies and SDV optimization.
The RBM Plan module translates the RBQM strategy into an operational monitoring plan with adaptive monitoring strategies, targeted SDV, reduced source data verification, and site risk stratification. It enables monitors to focus on critical data and high-risk sites while maintaining comprehensive oversight through central monitoring.
Explore the module's workflow through interactive interface mockups showing each step of the process.
Classify sites by risk level based on enrollment, data quality, deviation history, and monitoring findings.
| Site | Risk Level | Enrollment | Data Quality | Monitoring |
|---|---|---|---|---|
| MSK Cancer Center | Low | 92% | 96.8% | Quarterly |
| Mayo Clinic | Medium | 78% | 92.1% | Monthly |
| AIIMS Delhi | Low | 88% | 95.4% | Quarterly |
| Karolinska | High | 45% | 82.3% | Bi-weekly |
| NCC Tokyo | Medium | 62% | 89.7% | Monthly |
Define source data verification sampling plans with statistical justification and critical data focus.
Risk-adaptive monitoring visit calendar with frequency adjusted by site risk level.
Total Sites
42
across 8 countries
High Risk
4
Bi-weekly monitoring
Medium Risk
12
Monthly monitoring
Low Risk
26
Quarterly monitoring
How RBM Plan integrates with other CTMS modules in the platform.
Receives RBQM strategy and KRI definitions
RBM plan feeds central monitoring triggers
Site risk level drives monitoring schedule
SDV targets identified from EDC data
Monitoring findings linked to CAPA