{"abstract":"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 This guidance finalizes the draft guidance entitled \"Decentralized Clinical Trials for Drugs, Biological Products, and Devices\" issued on May 3, 2023.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/09/18/2024-21078.html","cfr_references":[],"citation":"89 FR 76481","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on September 18, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-D-2870"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-09-18","updated_at":"2024-09-18T09:57:31.229-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-D-2870-0095","allow_late_comments":false,"id":"FDA-2022-D-2870-0095","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2022-D-2870","title":"Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability"}],"document_number":"2024-21078","effective_on":null,"end_page":76482,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/09/18/2024-21078.xml","html_url":"https://www.federalregister.gov/documents/2024/09/18/2024-21078/conducting-clinical-trials-with-decentralized-elements-guidance-for-industry-investigators-and-other","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-21078?publication_date=2024-09-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-09-18/2024-21078/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":808,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-18/pdf/2024-21078.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-21078.pdf?1726577115","publication_date":"2024-09-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/09/18/2024-21078.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-D-2870","supporting_documents_count":0,"docket_id":"FDA-2022-D-2870","document_id":"FDA-2022-D-2870-0095","regulation_id_number":null,"title":"Decentralized Clinical Trials for Drugs, Biological Products, and Devices; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability","checked_regulationsdotgov_at":"2024-09-19T13:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":76481,"subtype":null,"title":"Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availability","toc_doc":"Conducting Clinical Trials with Decentralized Elements","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}