Defining QTLs & KRIs that Detect Risks in a Timely Manner (Part II) — The Process of Defining QTLs with Steve Young, Keith Dorricott, and WCG Senior Advisor Linda Sullivan

<p><span style="font-weight: 400;">In the second installment of our three-part series on defining and using Quality Tolerance Limits (QTLs), WCG Senior Advisor Linda Sullivan talks about the process of defining QTLs with Steve Young and Keith Dorricott.</span> <span style="font-weight: 400;">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.</span></p> <p><span style="font-weight: 400;">In April 2022, a three-part series summarizing those discussions and recommendations was published on the</span> <em><span style="font-weight: 400;">Applied Clinical Trials Journal</span></em> <span style= "font-weight: 400;">website:</span> <a href= "https://www.appliedclinicaltrialsonline.com/view/defining-quality-tolerance-limits-and-key-risk-indicators-that-detect-risks-in-a-timely-manner-reflections-from-early-adopters-on-emerging-best-practices-part-1"> <span style= "font-weight: 400;">https://www.appliedclinicaltrialsonline.com/view/defining-quality-tolerance-limits-and-key-risk-indicators-that-detect-risks-in-a-timely-manner-reflections-from-early-adopters-on-emerging-best-practices-part-1</span></a></p> <p><span style="font-weight: 400;">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 what factors go into the decision of whether to establish a QTL; the importance of key potential study failure points in developing QTLs; and how to determine the number of QTLs that should be implemented. The first part of this series discussed the relationship between QTLs and KRIs and the final