{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Computerized Systems Used in Clinical Trials.\" This document provides guidance about computerized systems that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained and/or submitted to FDA. This draft guidance, when finalized, will supercede the guidance of the same name issued in April 1999.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2004/10/04/04-22204.html","cfr_references":[],"citation":"69 FR 59239","comment_url":null,"comments_close_on":"2005-01-03","correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on the draft recommendations by January 3, 2005. General comments on agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. 2004D-0440"],"dockets":[],"document_number":"04-22204","effective_on":null,"end_page":59240,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2004/10/04/04-22204.xml","html_url":"https://www.federalregister.gov/documents/2004/10/04/04-22204/draft-guidance-for-industry-on-computerized-systems-used-in-clinical-trials-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/04-22204?publication_date=2004-10-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2004-10-04/04-22204/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":167,"last_updated":"2026-10-23 14:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2004-10-04/pdf/04-22204.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2004-10-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2004/10/04/04-22204.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T13:58:59Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59239,"subtype":null,"title":"Draft Guidance for Industry on Computerized Systems Used in Clinical Trials; Availability","toc_doc":"Computerized systems used in clinical trials","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":69}