Advanced Risk-Based Monitoring (RBM) Masterclass: Data-Driven Oversight & Implementation

Stop Looking at Every Page. Start Looking at the Trends.

The industry has shifted. Regulators (FDA, EMA) and the ICH-GCP E6(R2 & R3) guidelines now expect a risk-based approach. If you are still relying on 100% Source Data Verification (SDV) as your primary quality control, your trials are inefficient and at risk.

The Advanced RBM Masterclass moves beyond the “why” and focuses on the “how.” We teach you the mechanics of designing a Monitoring Plan that uses data analytics to target high-risk sites, reducing onsite burden while actually increasing data quality.

What You Will Master

• The RBM Architecture: How to build a monitoring strategy that blends On-site, Remote, and Centralized monitoring.
• Data Analytics: How to define and track Key Risk Indicators (KRIs)—such as high screen failure rates or AE under-reporting—to trigger interventions.
• Quality Tolerance Limits (QTLs): Setting the boundaries for trial acceptance (and what to do when they are breached).
• Centralized Statistical Monitoring (CSM): How to identify data fabrication or sloppiness by analyzing patterns across sites without visiting them.

Course Curriculum

Module 1: The Regulatory Mandate (R2 & R3)

• Why 100% SDV fails to detect critical errors.
• Interpreting ICH-GCP E6(R2) Section 5.0 (Quality Management).
• The impact of the upcoming E6(R3) on data governance.

Module 2: Risk Assessment & Planning

• Workshop: Conducting a Protocol Risk Assessment (RACT).
• Categorizing risks: Critical vs. Non-Critical data.
• Designing the “Integrated Monitoring Plan.”

Module 3: Metrics that Matter (KRIs & QTLs)

• Selecting the right Key Risk Indicators (KRIs) for your specific study.
• Setting thresholds: When does a “warning” become an “action”?
• Case Study: Detecting a site with “perfect” data (fraud detection).

Module 4: Centralized Monitoring Operations

• The role of the Central Monitor vs. the Field CRA.
• Remote reviewing of source data (rSDV) and privacy concerns.
• Using visualization tools (Spotfire/Tableau basics for clinical data).

Module 5: Change Management

• How to sell RBM to skeptical sites and PIs.
• Adjusting monitoring visit frequency based on site performance.
• Documentation: Proving to an auditor that you didn’t just “monitor less.”

Certification

Upon passing the final strategy assessment, you will be awarded the Certified RBM Implementation Specialist credential.