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Clinical Monitoring
What Is Risk-Based Monitoring in Clinical Trials?
Risk-based monitoring is a way of deciding where monitoring effort goes. Instead of visiting every site on a fixed calendar regardless of what the data show, the plan directs review toward the procedures, data and sites that carry more risk to participants or to the credibility of the results.
It is not an excuse to monitor less and hope. A risk-based plan that has no thresholds, no central review, and no route back to an on-site visit is just a thinner traditional plan.
What has to be true for it to work
Someone has to define the risks in the protocol, not in a slogan. Someone has to look at the signals often enough to change the next visit. Someone has to record why a site was, or was not, visited. And someone on the sponsor side has to be able to see that this is happening. That last part is sponsor oversight, including review of the monitoring plan itself.
Teams designing the visit model can start from clinical monitoring and from the comparison in monitoring versus oversight.