For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes.
Regulatory guidance like ICH, and FDA encourage sponsors to adopt advancedconcepts of monitoring in clinical research. Risk-based monitoring, centralised monitoring or remote monitoring have been very effective means of monitoring so far. Certainly, there have been magnificent improvements in the quality of the trial, safety of patients, efficiency and cost over the traditional monitoring approach. This article focuses on RBM Methodology as compared to traditional monitoring methods, challenges and rationale for Risk-Based Monitoring (RBM).