Risk-based monitoring (RMB) approach has been adopted by many sponsors and contract research organizations(CROs) to enhance the safety and efficiency of clinical trials and improve data quality. However, we see the adoption has been slow and implementation has been challenging. In this session we will cover from RBM concept, methodology and process to site risk assessment which is important for assuring patient safety and data integrity. Also we will share the experiences and lesson learned during RBM implementation in global and local pharma companies. Finally we will present the RBM metrics evolved in TransCelerate member companies as a method of measuring the impact of RBM and some trends which could be considered for future preparation.?