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. In this guidance, a decentralized clinical trial refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites.
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