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# Decentralized Clinical Trial Guidance
- URL: https://www.fdaweb.com/decentralized-clinical-trial-guidance/
- Published: 2024-09-17T12:00:00.000Z
- Updated: 2026-09-14T14:41:34.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5157786

FDA has published a guidance, *Conducting Clinical Trials with Decentralized Elements*, with recommendations for sponsors, investigators, and other interested parties about implementing decentralized elements in clinical trials. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements?utm%5Fmedium=email&utm%5Fsource=govdelivery) says decentralized elements can include telehealth, visits with trial personnel, in-home visits with remote trial personnel, or visits with local healthcare providers.

The guidance says FDA’s regulatory requirements for investigations of medical products are the same for trials that include or don’t include decentralized elements. The document fulfills a requirement in the Consolidated Appropriations Act of 2023.