A risk-based monitoring (RBM) approach has opened a pathway to the enhanced quality conduct and reporting of clinical study that the industry has been seeking for many years. Ashok Ghone of MakroCare, Sandra Sather of Clinical Pathways LLC, Sue Fitzpatrick of Redtree People, and Jane Tucker discuss some of the key aspects of RBM-like risk assessment, including: risk management, monitoring plan, centralised monitoring, and technology.