AQC QbD-RBQM-Quality Improvement CoP Group Exploring Current QTL Practices and Use of KRIs

The WCG MCC QTL working group – a multistakeholder group of industry experts – met on 10 occasions over a 5-month period in 2021 to discuss challenges and best practice approaches for implementation of Quality Tolerance Limits (QTLs). The work culminated in a three-part article in Applied Clinical Trials. MCC founder Linda Sullivan and QTL Working Group co-leads Steve Young (CluePoints) and Keith Dorricott (WCG Avoca) shared highlights of the work with WCG AQC QbD-RBQM-Quality Improvement Community of Practice (CoP) members at a virtual meeting on 8 June 2022. During the meeting, they shared how the sub-team worked together and some of the key concepts discussed in the Applied Clinical Trials article. Meeting participants shared information about current QTL practices such as QTL implementation progress (e.g., proportion of studies, phase / types of studies); number of QTLs implemented for each study; sources used to determine QTL thresholds; and practices related to modifying QTL parameters and thresholds during study conduct. Consortium members can view the polling results by downloading the meeting slides or viewing the archive recording of the meeting available in the QbD-RBQM-Quality Improvement meeting archive library in the AQC Knowledge Center.

Consortium members will continue to explore lessons learned from early QTL adopters at the next Community of Practice meeting on 13 July 2022. The topic of the meeting is Using KRIs as Companions to QTLs – Getting Earlier Signals of Risk QTL focusing on where QTLs work, and where they don’t as well as using KRIs as companions to QTLs.

AQC Members can log into the AQC Knowledge Center and visit the meeting calendar to register. Contact us for information on establishing an AQC user account.

Additional Resources

Applied Clinical Trials, 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), (Part 2), and (Part 3)

CTO Podcast Episode 34: 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

CTO Podcast Episode 35: 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

CTO Podcast Episode 36: QTLs & Early Detection of Risk (Part III of the QTL Series) with Steve Young, Keith Dorricott, and WCG Senior Advisor Linda Sullivan