{"abstract":"The Food and Drug Administration is publishing a guideline entitled ``Structure and Content of Clinical Study Reports.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline is intended to facilitate the compilation of a single worldwide core clinical study report acceptable to all regulatory authorities.","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/1996/07/17/96-18000.html","cfr_references":[],"citation":"61 FR 37320","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Effective July 17, 1996. Submit written comments at any time.","disposition_notes":null,"docket_ids":["Docket No. 95D-0218"],"dockets":[],"document_number":"96-18000","effective_on":"1996-07-17","end_page":37343,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1996/07/17/96-18000/international-conference-on-harmonisation-guideline-on-structure-and-content-of-clinical-study","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/96-18000?publication_date=1996-07-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1996-07-17/96-18000/mods.xml","not_received_for_publication":null,"page_length":24,"page_views":{"count":1523,"last_updated":"2026-10-23 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1996-07-17/pdf/96-18000.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1996-07-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1996/07/17/96-18000.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-09-21T06:32:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37320,"subtype":null,"title":"International Conference on Harmonisation; Guideline on Structure and Content of Clinical Study Reports; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":61}