{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled, \"Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval.\" The guidance announced in this document finalizes the draft guidance of the same title dated January 2010. This document also supersedes the Information Sheet, Continuing Review After Study Approval. The guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations.","action":"Notice.","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/2012/02/27/2012-4425.html","cfr_references":[],"citation":"77 FR 11555","comment_url":"http://www.regulations.gov/commenton/FDA-2009-D-0605-0024","comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments at any time. Submit electronic comments to http://www.regulations.gov. Submit written comments on the guidance to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-D-0605"],"dockets":[],"document_number":"2012-4425","effective_on":null,"end_page":11556,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/02/27/2012-4425.xml","html_url":"https://www.federalregister.gov/documents/2012/02/27/2012-4425/guidance-for-institutional-review-boards-clinical-investigators-and-sponsors-institutional-review","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-4425?publication_date=2012-02-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-02-27/2012-4425/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1191,"last_updated":"2026-10-23 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-02-27/pdf/2012-4425.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-04425.pdf?1330094347","publication_date":"2012-02-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/02/27/2012-4425.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2009-D-0605","supporting_documents_count":0,"docket_id":"FDA-2009-D-0605","regulation_id_number":null,"title":"Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval; Availability ","checked_regulationsdotgov_at":"2023-03-01T19:46:22Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2009-D-0605-0024","significant":null,"signing_date":null,"start_page":11555,"subtype":null,"title":"Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Continuing Review After Clinical Investigation Approval; Availability","toc_doc":"Institutional Review Board Continuing Review After Clinical Investigation Approval","toc_subject":"Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability:","topics":[],"type":"Notice","volume":77}