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ICH E6(R3) Monitoring Strategy

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.

Compare RBM vs Traditional

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

Aspect
Traditional Monitoring
Risk-Based Monitoring
Source Data Verification
100% SDV for all data points
10-20% targeted SDV based on risk
Site Visit Frequency
Fixed schedule (e.g., every 4-6 weeks)
Risk-driven, adaptive frequency
Issue Detection
Found during next site visit
Real-time with centralized analytics
Cost Efficiency
High travel and time costs
20-30% cost reduction typical
Data Analysis
Site-by-site, retrospective
Cross-site patterns, predictive
Regulatory Alignment
Legacy approach, still accepted
ICH E6(R3) expectation

Core Components of Risk-Based Monitoring

Centralized Monitoring

Remote review of accumulating data using statistical methods to identify outliers, trends, and patterns across sites.

Statistical process controlCross-site comparisonsAutomated alerts

Key Risk Indicators (KRIs)

Predefined metrics that signal potential quality issues, triggering investigation or intervention when thresholds are exceeded.

Protocol deviation ratesQuery response timesMissing data percentages

Targeted Site Visits

On-site monitoring visits focused on high-risk activities, triggered issues, and critical verification needs.

Risk-prioritized schedulingIssue-driven scopeEfficient resource use

Remote Data Review

Continuous review of eCRF data, safety reports, and site metrics without travel to clinical sites.

Real-time data accessQuery managementTrend identification

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.

Learn RBQM

Implementing Risk-Based Monitoring

A practical framework for transitioning to risk-based monitoring in your clinical trials

1

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
2

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.)
3

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
4

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
5

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
6

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

Screen failure rate> 40%
Enrollment rate vs target< 80% of expected
Subject withdrawal rate> 15%

Data Quality

Query rate per CRF page> 0.3 queries
Query resolution time> 7 days
Missing data rate> 5% for critical fields

Protocol Compliance

Protocol deviation rate> 10 per subject
Major deviation rate> 2%
Visit window compliance< 90%

Safety Reporting

AE reporting timeliness> 3 days delay
SAE reporting compliance< 100% within 24h
AE rate vs expected> 2 SD from mean
Frequently Asked Questions

RBM Questions Answered

Common questions about Risk-Based Monitoring and its implementation in clinical trials

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