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GUIDANCE DOCUMENT

Conducting Clinical Trials With Decentralized Elements September 2024

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2022-D-2870
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Oncology Center of Excellence

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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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-2870.

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