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Is Risk-Based Monitoring The Same As Remote Monitoring?



While it’s true that both terms include “monitoring,” it’s not true that they’re synonymous. In fact, remote monitoring is actually a subset of risk-based monitoring – a type or form of monitoring, rather than a monitoring strategy, like RBM. 

In an RBM strategy, sites that need the most help get the most intense monitoring. Sites that need less help probably don’t need in-person visits at regular intervals throughout the study. Their records can be reviewed from a distance, sometimes independently of site involvement and other times including conference or video calls with site personnel. This is the concept of remote monitoring; it just means monitoring from somewhere other than the physical site.

RBM is a totally different animal. RBM is a strategy for monitoring that involves performing a detailed risk assessment for each and every study, and then building a monitoring plan that mitigates the risks specific to the study. The monitoring plan describes the circumstances under which sites require on-site vs. remote monitoring, as well as identifies the most critical source data points that need to be verified.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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