How Artificial Intelligence Can Enhance the Clinical Data Review and Cleaning Process
Learn how AI/ML can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
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.
