This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs)  for drugs,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.


FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials. Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directs FDA to “issue or revise draft guidance that includes recommendations to  clarify and advance the use of decentralized clinical studies to support the development of drugs  and devices,” not later than December 29, 2023.

This guidance provides recommendations  related to FDA’s requirements for investigations of medical products when applied to DCTs and  fulfills the requirement set forth in section 3606(a)(1) of FDORA. The content described in  section 3606(b) of FDORA is further addressed through this guidance’s reference to the draft  guidance for industry, investigators, and other stakeholders entitled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (December 2021)