Decentralized Clinical Trials for Drugs, Biological Products, and Devices

GUIDANCE DOCUMENT

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. In fully decentralized clinical trials, all activities take place at locations other than traditional trial sites. These trial-related activities may take place at the homes of trial participants or in local health care facilities that are convenient for trial participants. In hybrid DCTs, some trial activities involve in-person visits by trial participants to traditional clinical trial sites, and other activities are conducted at locations other than traditional clinical trial sites, such as participants’ homes.

05/01/2023

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