INTRODUCTION
This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.
Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants.
Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local health care providers (HCPs) (see sections II and III.B).
In this guidance, a decentralized clinical trial (DCT) refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites.
FDA GUIDANCE Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties
SEPTEMBER 2024