Courtney McBean

Often overlooked in early evaluation of RBM are the tools and technologies required for successful implementation. Without the right tools to track and prioritize the shift from traditional monitoring to RBM, successful implementation is doubtful, posing detrimental consequences not only for the monitors, but also the overall trial.

That's because the discussion shifted away from one focused on changing monitoring methods and doing reduced source document verification (SDV) to 'intelligent monitoring.'

With so many sponsors and CROs focused on finding the right technology solution for implementing risk based monitoring, a key element often gets overlooked--the risk assessment.