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 final guidance, released on 17 September.
The final guidance also provides more detail on the qualifications for local health care providers (HCPs) and what they can and cannot do in studies with decentralized elements. For...