Taking the ′Risk′ out of risk-based monitoring

Critical utility of e-solutions in risk based monitoring

“…Ordinarily, such a risk-based plan would include a mix of centralized and on-site monitoring practices. [1][2][3][4][5] Thus, RBM, which involves centralized/offsite monitoring, is an evaluation carried out by sponsor personnel or representatives (e.g., central monitors, data management associates, or statisticians) at an offsite location i.e. not at the sites at which the clinical investigation is being conducted, based on risk assessment for the study & site, and accordingly directs the requirement for centralized/remote monitoring, or onsite monitoring.…”