This is where Risk-Based Monitoring (RBM) comes into play. RBM is a complementary strategy employed during the trial execution, focusing resources on significant and likely risks to data quality and processes critical to human subject protection and trial integrity.
In essence, RBM acts as a dynamic component within the QbD framework. QbD lays the groundwork, pinpointing the critical quality aspects during the design phase. RBM then uses this information to guide the monitoring strategy throughout the study. Working together, these methods form a robust shield to ensure the quality and safety of clinical trials. Their use is endorsed and encouraged by regulatory authorities worldwide, reinforcing their importance in clinical research landscape.