Track 54: Risk-Based Monitoring

Overview: Risk-Based Monitoring (RBM)

Risk-Based Monitoring (RBM) is a modern clinical trial oversight approach that focuses monitoring efforts on critical study data, processes, and sites most likely to impact patient safety and data integrity. Unlike traditional 100% source data verification (SDV), RBM is strategic and adaptive, using centralized and remote monitoring tools to identify risks early and allocate resources efficiently. RBM is encouraged by regulatory authorities like the FDA, EMA, and ICH-GCP E6(R2) guidelines. It enhances trial quality, cost-efficiency, and regulatory compliance, especially in large or multi-center trials.

Key Sub-Topics in Risk-Based Monitoring:

Centralized Monitoring · Remote Monitoring · Site Risk Assessment · Key Risk Indicators (KRIs) · Critical Data and Process Identification · Triggered Site Visits · Monitoring Plan Development · Source Data Review (SDR) vs. Source Data Verification (SDV) · Data Trend Analysis · Root Cause Investigation · CAPA Implementation (Corrective and Preventive Actions) · Regulatory Expectations for RBM · Role of Clinical Data Management · Use of eClinical Tools and Dashboards · Benefits and Challenges of RBM