Issue Date: September 18, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Conducting Clinical Trials With Decentralized Elements
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. Additional Guidance Resources: Conducting Clinical Trials With Decentralized Elements Guidance Snapshot
Download the Guidance Document
