Risk-Based Monitoring (RBM) Training
Master centralized monitoring and data-driven oversight strategies aligned with ICH E6(R3). Learn to use Key Risk Indicators (KRIs), remote data review, and targeted site visits to monitor clinical trials more efficiently while maintaining quality.
Centralized
Remote Monitoring
KRI-Driven
Analytics Approach
Targeted
Site Visits
Why Risk-Based Monitoring Matters
- Reduce monitoring costs by 20-30% through centralized review
- Detect data quality issues earlier with real-time analytics
- Focus on-site visits where they matter most
- Meet ICH E6(R3) expectations for risk-proportionate monitoring
RBM vs Traditional Monitoring
Understanding why regulatory agencies and sponsors are moving toward risk-based approaches
Core Components of Risk-Based Monitoring
Centralized Monitoring
Remote review of accumulating data using statistical methods to identify outliers, trends, and patterns across sites.
Key Risk Indicators (KRIs)
Predefined metrics that signal potential quality issues, triggering investigation or intervention when thresholds are exceeded.
Targeted Site Visits
On-site monitoring visits focused on high-risk activities, triggered issues, and critical verification needs.
Remote Data Review
Continuous review of eCRF data, safety reports, and site metrics without travel to clinical sites.
RBM is Part of RBQM
Risk-Based Monitoring is one component of Risk-Based Quality Management. Learn about the complete RBQM framework including Quality by Design and Critical to Quality factors.
Implementing Risk-Based Monitoring
A practical framework for transitioning to risk-based monitoring in your clinical trials
Define Monitoring Plan
Document your risk-based monitoring strategy including KRI definitions, thresholds, and response procedures.
- Identify Critical to Quality factors
- Define KRI metrics and thresholds
- Specify centralized review frequency
- Document escalation procedures
Configure Systems
Set up technology infrastructure for centralized monitoring including data visualization and alerting.
- Implement centralized monitoring platform
- Configure KRI dashboards
- Set up automated alerts
- Integrate data sources (EDC, CTMS, etc.)
Establish Baselines
Collect initial data to establish normal ranges and refine thresholds for meaningful alerting.
- Run pilot phase for KRI calibration
- Analyze historical data if available
- Adjust thresholds based on reality
- Document baseline metrics
Train Teams
Ensure monitors, data managers, and site staff understand RBM processes and their roles.
- Train CRAs on new monitoring approach
- Educate sites on expectations
- Train data management on KRI review
- Document roles and responsibilities
Monitor & Respond
Execute ongoing centralized review, respond to alerts, and conduct targeted site visits.
- Conduct regular centralized reviews
- Investigate KRI threshold breaches
- Schedule risk-driven site visits
- Document findings and actions
Adapt & Improve
Continuously evaluate RBM effectiveness and refine approach based on lessons learned.
- Review KRI performance quarterly
- Assess issue detection effectiveness
- Refine thresholds as needed
- Update monitoring plan
Example Key Risk Indicators (KRIs)
Enrollment & Retention
Data Quality
Protocol Compliance
Safety Reporting
RBM Questions Answered
Common questions about Risk-Based Monitoring and its implementation in clinical trials
Continue Learning
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