1. Executive Summary

This guidebook provides an overview of the current and proposed regulatory landscape applicable in the USA in relation to Decentralized Clinical Trials (“DCTs”) with investigational medicinal products.

The Food and Drug Administration (FDA) is the regulatory authority that regulates clinical investigations of medical products in the United States (US). 

The Federal Registry (FR) is the official daily publication for rules, proposed rules, and notices for Federal agencies and organizations, as well as executive orders and other presidential documents. Proposed rules are initially published in the FR for public comment and subsequently published in the Code for Federal Regulations after the rule is final.

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules that were published in the FR. It is divided into 50 titles that represent broad areas subject to Federal Regulation.

The Consolidated Appropriations Act 2023 was signed into law on 29^th December 2022. In May 2023, the FDA released for public comment the draft guideline, “Decentralized Clinical Trials for Drugs, Biological Products, and Devices”, coupled with the FDA guidance on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (Dec 2023)”, making the USA a favourable country to conduct DCTs.

In the US, the ethical review takes place via the Institutional Review Boards; those can be local (LIRB) or central (CIRB).

In this guidebook, the focus is exclusively on commercially sponsored clinical trials. We have not addressed clinical trials which are federally funded or sponsored, which are subject to an overlapping regulatory regime, which the Department of Health and Human Sciences (HHS) administers.