USA – FDA’s final guidance on decentralized clinical trials (DCTs) adds clarity on healthcare providers (HCPs) task log, inspection requirements, data variability

The US Food and Drug Administration’s (FDA) final guidance on decentralized clinical trials (DCTs) addresses some key issues from the draft guidance raised by clinical experts and industry groups, including providing more information on requirements to keep a task log of healthcare providers (HCPs), physical inspection requirements, and clarifying challenges around data variability in DCTs. The agency defines DCTs as occurring at non-traditional clinical trial locations, such as a participan...