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Clinical Trial Optimization Podcast

Grouping Investigative Sites into Risk Groups for “Fit for Purpose” Monitoring with Tammy Finnigan, Elizabeth Robertson, and Linda Sullivan


How can organizations best use data to tier sites into groups to support “fit for purpose” risk monitoring? That’s one of the key issues explored during Linda Sullivan’s interview with two CTO guests: Tammy Finnigan, Chief Operating Officer and Elizabeth Robertson RBM operations consultant at Triumph Research Intelligence. Some sponsors are still running traditional monitoring models while they begin developing “fit for purpose” monitoring – an approach that deploys monitoring resources to the sites based on their risk levels, according to the two guests. Grouping sites into risk categories at the beginning of a study enables you to assign more experienced monitors with the sites most likely to need monitoring oversight. Example of site data being examined under the “fit for purpose” model include historical data, such as recruitment and retention, consent, inclusion criteria, and missing data. There are human aspects such as site staff changes that should be included in this evaluation as well, the guests note.

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