Clinical trial monitoring has traditionally relied on routine on site visits and exhaustive source data verification (SDV) to ensure patients’ safety and data integrity. While effective at detecting individual errors, this approach is resource-intensive and often limited in its ability to identify systemic risk patterns across complex trials. In response, regulatory authorities advocated for more targeted, risk-proportionate oversight models. The European Medicines Agency’s ‘Reflection Paper on Risk-Based Quality Management in Clinical Trials’ and the U.S. FDA’s guidance on ‘Oversight of Clinical Investigations – A Risk-Based Approach,’ (2013) formally endorsed these strategies. Likewise, ICH E6(R2) and the evolving E6(R3) revisions emphasise systematic risk management throughout the trial lifecycle, integrating risk identification, assessment, control, communication and review.