{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Use of Data Monitoring Committees in Clinical Trials.\" This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures and practices should be considered to guide their operation. When finalized, this guidance will supersede the final guidance for clinical trial sponsors entitled \"Establishment and Operation of Clinical Trial Data Monitoring Committees,\" issued in March 2006. This draft guidance is not final nor is it in effect at this time.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2024/02/13/2024-02849.html","cfr_references":[],"citation":"89 FR 10084","comment_url":null,"comments_close_on":"2024-04-15","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by April 15, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by April 15, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2001-D-0219"],"dockets":[{"supporting_documents":[{"title":"Tab E - Tab E-Guidance for Industry, ICR E6, Good Clinica1 Practice: Consolidated Guidance, April 1996 [Guidance of 3/28/2006]","document_id":"FDA-2001-D-0219-0014"},{"title":"Tab D - Guidance for Industry, ICH E9, Statistical Principles forClinical Trials, September 1998 [Guidance of 3/28/2006]","document_id":"FDA-2001-D-0219-0013"},{"title":"Tab C - DHHS, Finaneial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection May 5, 2004. [Guidance of 3/28/2006]","document_id":"FDA-2001-D-0219-0012"},{"title":"List of References [Guidance for Clinical Trial SponsorsEstablishment & Operation of Clinical Trial Monitoring Committees 3/28/2006]","document_id":"FDA-2001-D-0219-0011"},{"title":"Clinical Trial Sponsors on the Establishment & Operation of Clinical Trial Monitoring Committees, November 2201 - Draft Guidance","document_id":"FDA-2001-D-0219-0010"},{"title":"Supporting Statement","document_id":"FDA-2001-D-0219-0008"},{"title":"Supporting Statement","document_id":"FDA-2001-D-0219-0007"},{"title":"Guidance for Clinical Trial Sponsors; Establishment and Operation of Clinical Trial Data Monitoring Committees, March 2006","document_id":"FDA-2001-D-0219-0006"},{"title":"Guidance for Clinical Trial Sponsors; Establishment and Operation of Clinical Trial Data Monitoring Committee December 2005 - Draft Guidance","document_id":"FDA-2001-D-0219-0003"}],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2024-02-13T09:56:46.689-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2001-D-0219-0015","allow_late_comments":null,"id":"FDA-2001-D-0219-0015","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":9,"id":"FDA-2001-D-0219","title":"Establishment & Operation of Clinical Trial Monitoring Comm"}],"document_number":"2024-02849","effective_on":null,"end_page":10087,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/02/13/2024-02849.xml","html_url":"https://www.federalregister.gov/documents/2024/02/13/2024-02849/use-of-data-monitoring-committees-in-clinical-trials-draft-guidance-for-industry-availability-agency","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-02849?publication_date=2024-02-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-02-13/2024-02849/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1722,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-02-13/pdf/2024-02849.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-02849.pdf?1707745521","publication_date":"2024-02-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/02/13/2024-02849.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab E - Tab E-Guidance for Industry, ICR E6, Good Clinica1 Practice: Consolidated Guidance, April 1996 [Guidance of 3/28/2006]","document_id":"FDA-2001-D-0219-0014"},{"title":"Tab D - Guidance for Industry, ICH E9, Statistical Principles forClinical Trials, September 1998 [Guidance of 3/28/2006]","document_id":"FDA-2001-D-0219-0013"},{"title":"Tab C - DHHS, Finaneial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection May 5, 2004. [Guidance of 3/28/2006]","document_id":"FDA-2001-D-0219-0012"},{"title":"List of References [Guidance for Clinical Trial SponsorsEstablishment & Operation of Clinical Trial Monitoring Committees 3/28/2006]","document_id":"FDA-2001-D-0219-0011"},{"title":"Clinical Trial Sponsors on the Establishment & Operation of Clinical Trial Monitoring Committees, November 2201 - Draft Guidance","document_id":"FDA-2001-D-0219-0010"},{"title":"Supporting Statement","document_id":"FDA-2001-D-0219-0008"},{"title":"Supporting Statement","document_id":"FDA-2001-D-0219-0007"},{"title":"Guidance for Clinical Trial Sponsors; Establishment and Operation of Clinical Trial Data Monitoring Committees, March 2006","document_id":"FDA-2001-D-0219-0006"},{"title":"Guidance for Clinical Trial Sponsors; Establishment and Operation of Clinical Trial Data Monitoring Committee December 2005 - Draft Guidance","document_id":"FDA-2001-D-0219-0003"}],"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-2001-D-0219","supporting_documents_count":9,"docket_id":"FDA-2001-D-0219","document_id":"FDA-2001-D-0219-0015","regulation_id_number":null,"title":"Establishment & Operation of Clinical Trial Monitoring Comm","checked_regulationsdotgov_at":"2024-02-14T14:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":10084,"subtype":null,"title":"Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","toc_doc":"Use of Data Monitoring Committees in Clinical Trials","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":89}