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Clinical Trial Optimization Podcast

Defining QTLs and KRIs that Detect Risks in a Timely Manner – Part 1 Relationship of QTLs & KRIs with Steve Young, Keith Dorricott, and WCG Senior Advisor Linda Sullivan


In the first of this three-part series on defining and using Quality Tolerance Limits (QTLs), WCG Senior Advisor discusses the relationship of QTLs & KRIs with Steve Young and Keith Dorricott. Young is the Chief Scientific Officer at CluePoints, who oversees the research and development of advanced methods for data analytics, data surveillance, and risk. Dorricott is a Master Black Belt who has spent more than 15 years applying process improvement techniques to address clinical research problems. Young and Dorricott co-led a groundbreaking, WCG Metrics Champion Consortium QTL working group, which developed a guidance on QTL emerging best practices for Consortium members. In April 2022, a three-part series summarizing those discussions and recommendations was published on the Applied Clinical Trials Journal website:

The three-part podcast series is designed to be a valuable podcast companion resource to the website article. In this episode, Young, Dorricott, and Sullivan discuss parameters and thresholds as they apply to QTL and KRIs, concluding QTLs should be considered as a designated subset of KRIs. The group also discusses the working group’s mission; its process for determining best practices; the vendor perspective on QTLs; the importance of tracking risk; and the relationship of QTLs to centralized monitoring. The second part of the series will concentrate on defining QTLs and the final part of the series will focus on methods for early detection of risk.

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