Conducting Clinical Trials With Decentralized Elements September 2024

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-clinical-trials-decentralized-elements?utm_medium=email&utm_source=govdelivery Guidance Snapshot for Guidance Conducting Clinical Trials with Decentralized Elements FDA recently published the guidance snapshot that accompanies the final guidance Conducting Clinical Trials with Decentralized Elements. FDA’s Guidance Snapshot Pilot Program aims to increase the general public’s awareness of and engagement with FDA guidance documents—and support the efficient application of recommendations. The snapshot highlights key points in the guidance document and is not a substitute for the guidance document. The Conducting Clinical Trials with Decentralized Elements guidance provides FDA’s recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants. Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local health care providers (HCPs) such as doctors or nurses. The incorporation of decentralized elements may help improve trial participant engagement, recruitment, enrollment, and retention—and may help produce clinical trials that are representative of the target population. Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties https://www.fda.gov/media/189263/download?attachment=&utm_medium=email&utm_source=govdelivery Guidance Snapshot Pilot https://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot?utm_medium=email&utm_source=govdelivery