Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, investigators, and other interested parties entitled "Conducting Clinical Trials With Decentralized Elements." This guidance provides recommendations regarding the implementation of decentralized elements in clinical trials for drugs, biological products, and devices. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants (e.g., telehealth visits with investigators or visits with local healthcare providers (HCPs)). FDA's regulatory requirements are the same for trials that include decentralized elements and trials that do not include decentralized elements. To help ensure the appropriate oversight trials with decentralized elements, the integrity of trial data, and the safety of trial participants, this guidance covers the responsibilities of sponsors and investigators. This guidance finalizes the draft guidance entitled "Decentralized Clinical Trials for Drugs, Biological Products, and Devices" issued on May 3, 2023.
Abstract as published in the Federal Register.
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