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Decentralized Trials: FDA Final Guidance Eliminates Need For Local Provider Activity Tracking

 
• By Sue Sutter

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.

Health care provider
Local, qualified health care providers may perform certain activities in clinical trials with decentralized elements. • Source: Shutterstock

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.

The agency removed language on the need to maintain a task log of local providers in its decentralized clinical trials...

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