The US Food and Drug Administration has decided not to require that investigators undertake formal tracking of local health care provider activities in clinical studies with decentralized elements.
Decentralized Trials: FDA Final Guidance Eliminates Need For Local Provider Activity Tracking
Draft recommendation for investigators to maintain a task log of activities that local health care providers perform was removed from final guidance on decentralized clinical trials. Other changes include more detail on US FDA oversight and what HCPs can and cannot do in such studies.
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