Abstract:Background - As investigator site audits have largely been conducted remotely during the COVID-19 pandemic, remote quality monitoring has gained some momentum. To further facilitate the conduct of remote Quality Assurance (QA) activities, we developed new quality indicators, building on a previously published statistical modelling methodology.
Methods - We modeled the risk of having an audit or inspection finding using historical audits and inspections data from 2011 - 2019. We used logistic regression to mo… Show more
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