{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled \"E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1).\" The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance amends the guidance entitled \"E6 Good Clinical Practice: Consolidated Guidance (E6(R1))\" to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The guidance is intended to improve clinical trial quality and efficiency, while maintaining human subject protection and reliability of trial results.","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/2018/03/01/2018-04154.html","cfr_references":[],"citation":"83 FR 8882","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on March 1, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-D-0719"],"dockets":[],"document_number":"2018-04154","effective_on":null,"end_page":8883,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/03/01/2018-04154.xml","html_url":"https://www.federalregister.gov/documents/2018/03/01/2018-04154/e6r2-good-clinical-practice-integrated-addendum-to-e6r1-international-council-for-harmonisation","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-04154?publication_date=2018-03-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-03-01/2018-04154/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":7861,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-03-01/pdf/2018-04154.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-04154.pdf?1519825559","publication_date":"2018-03-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/03/01/2018-04154.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-2018-D-0719","supporting_documents_count":0,"docket_id":"FDA-2018-D-0719","regulation_id_number":null,"title":"E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1); International Council for Harmonisation; Guidance for Industry; Availability","checked_regulationsdotgov_at":"2018-03-21T10:00:15Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8882,"subtype":null,"title":"E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1); International Council for Harmonisation; Guidance for Industry; Availability","toc_doc":"E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1); International Council for Harmonisation","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}