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For Mitchell Katz, PhD, Executive Director, Medical Research Operations, Purdue Pharma, risk-based monitoring is a key discussion for clinical operations executives now. Katz told Applied Clinical Trials, “Historically, we always looked at monitoring as something you had to do on a routine interval for any program. And it’s extremely costly. Yet it’s known that the increased frequency in monitoring doesn’t necessarily deliver better quality.”
For decades, most sponsors have conducted on-site monitoring visits every six to eight weeks with the goal of 100% source document verification, for all of the data, on all of the subjects. In its Guidance Document released in August 2011, the FDA put forth its thoughts on risk-based monitoring as a way to create a monitoring plan, as well as determining centralized monitoring over on-site monitoring needs.
Using Risk-Based Monitoring and the move away from 100% Source Document Verification gets to the heart of resources and how to more intelligently and effectively monitor trials. The industry is still working through this less-than-a-year-old FDA guidance, however, the following articles help explain centrally-based monitoring; SDV and more:
Kenneth Getz, MBA, Research Fellow at Tufts CSDD; Founder of CISCRP and CenterWatch; and Applied Clinical Trials columnist’s Low Hanging Fruit in the Fight Against Inefficiency.
Wayne Kubick, Chief Technology Officer, CDISC and Applied Clinical Trials columnist, blogs FDA’s Remote Monitoring Guidance: How Much is Enough?
An Idea Whose Time Came, how remote monitoring appears in patient-facing trials.