Risk_Based_Monitoring_Implementation

Implementing Risk-Based Monitoring from a Data Perspective

Each sponsor and their partners enter the Risk-Based Monitoring (RBM) process at different places. Now that the new version of GCP (ICH GCP E6 (R2) addendum) mandates risk-based thinking, all of us in clinical trials need to embrace risk-based processes. What exactly does this mean? We need to begin implementing risk assessment, risk measurements, task…