RBQM Ops 2022 - How does monitoring drive quality and efficiency?

How does Monitoring Drive Quality and Efficiency?

SUMMARY KEYWORDS
monitoring, quality, site, study, data, role, efficiencies, band aid approach, mixed metaphors, safety, clinical trials, responsibilities, drive, checking, protocol deviations, matters, industry, trend, trial

DUNCAN HALL:

Our next speaker, Esther Huffman O'Keefe is well known and well respected in the sector for her knowledge, experience and pragmatism when it comes to implementing RBQM. Now I first met Esther at an RBQM industry events and have crossed paths with her many times since, as well as working with her on a very important COVID project for her previous employer. Esther was the RBQM workstream engagement co lead for TransCelerate, working on solutions, publications and education sessions across the industry and clinical trial site forums. Given her wealth of experience, I know this next session on “How does monitoring drive quality and efficiency?” is going to be full of useful insights and information. Esther, welcome to RBQM Operations. 22. Thank you for being here. Over to you.

ESTHER HUFFMAN O’KEEFE:

Thank you so much, Duncan, I am delighted to be here. And even more excited to have been given the chance to talk a little bit about how does monitoring drive quality and efficiency. These are topics that have been near and dear to my heart, and many of our hearts in the last decade or so. And I'm happy to have the chance to go through just a few slides to think about “What is monitoring, what is quality, and how are they related?”

I've put together a set of very mixed metaphors for today. And at least one incredibly curious analogy that will help us think about what is monitoring? Is it a roll? Or is it a process? What is quality? And how can we measure it when we think about our clinical trials? And what, if anything, is it possible to understand about efficiencies in clinical trials, especially in the risk-based monitoring or risk-based quality management space. So I'm looking forward to our discussion today and even more to the panel discussions that will follow.

To get us started. When we think about monitoring and how to get our hands around what monitoring is, GCP includes a definition that requires a role whose focus is to ensure subject protection by checking written informed consent, ensure accurate and complete data by looking at the source documents, and confirm that the study is being conducted per protocol by reviewing the site documents, including IP accountability...