Agency emphasizes feasibility and consistency when it comes to remote administration of clinician-reported and performance outcome assessments in studies disrupted by the pandemic; latest guidance update also discusses remote site monitoring, as well as alternative procurement and administration of investigational products.
Remote outcome assessments should be conducted in a consistent manner to minimize variability, US FDA says. • Source: Shutterstock
The US Food and Drug Administration is emphasizing feasibility and consistency when it comes to remote collection of performance and clinician-reported outcome assessments in clinical trials impacted by the COVID-19 pandemic.
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