{"abstract":"The Food and Drug Administration (FDA) Detroit District Office, in co-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRB, and research sponsors. Date and Time: The public workshop will be held on May 9 and 10, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Marriott Ann Arbor Ypsilanti at Eagle Crest, 1275 S. Huron St., Ypsilanti, MI 48197, 800-606-7044. Contact: Society of Clinical Research Associates (SoCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, 1-800-762-7292 or 215-822- 8644, FAX: 215-822-8633, email: SoCRAmail@aol.com, Web site: http:// www.SoCRA.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.); or Nancy Bellamy, Food and Drug Administration, Detroit District Office, 300 River Pl., Suite 5900, Detroit, MI 48207, 313-393-8143, Fax: 313- 393-8139, email: nancy.bellamy@fda.hhs.gov. Accommodations: Attendees are responsible for their own accommodations. Please mention SoCRA to receive the hotel room rate of $119 plus applicable taxes (available until April 17, 2012 or until the SoCRA room block is filled).","action":"Notice of public workshop.","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/2012/02/15/2012-3553.html","cfr_references":[],"citation":"77 FR 8886","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0001"],"dockets":[],"document_number":"2012-3553","effective_on":null,"end_page":8887,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/02/15/2012-3553.xml","html_url":"https://www.federalregister.gov/documents/2012/02/15/2012-3553/food-and-drug-administration-clinical-trial-requirements-regulations-compliance-and-good-clinical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-3553?publication_date=2012-02-15","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-02-15/2012-3553/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":138,"last_updated":"2026-08-26 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-02-15/pdf/2012-3553.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-03553.pdf?1329227871","publication_date":"2012-02-15","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/02/15/2012-3553.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Closed Meeting Reports of the Food and Drug Administration for the fiscal year 2012","document_id":"FDA-2012-N-0001-0023"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-0001","supporting_documents_count":null,"docket_id":"FDA-2012-N-0001","regulation_id_number":null,"title":"Advisory Committee, Workshops, and Conferences Notices Various Meeting Notices (eg., Task Force Meeting, etc.)","checked_regulationsdotgov_at":"2012-03-06T08:06:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8886,"subtype":null,"title":"Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice","toc_doc":"Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice","toc_subject":"Workshops:","topics":[],"type":"Notice","volume":77}