{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring.\" This guidance assists sponsors in developing risk-based monitoring strategies and plans for clinical investigations of human drugs, biologics, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting. The guidance makes clear that sponsors can use a variety of approaches to meet their responsibilities for monitoring investigational new drug or investigational device exemption studies.","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/2013/08/07/2013-19004.html","cfr_references":[],"citation":"78 FR 48173","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-D-0597"],"dockets":[],"document_number":"2013-19004","effective_on":null,"end_page":48174,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/08/07/2013-19004.xml","html_url":"https://www.federalregister.gov/documents/2013/08/07/2013-19004/guidance-for-industry-on-oversight-of-clinical-investigations-a-risk-based-approach-to-monitoring","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-19004?publication_date=2013-08-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-08-07/2013-19004/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1660,"last_updated":"2026-07-28 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-08-07/pdf/2013-19004.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-19004.pdf?1375820686","publication_date":"2013-08-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/08/07/2013-19004.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals","document_id":"FDA-2011-D-0597-0063"},{"title":"Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Comment Request; Oversight of\nClinical Investigations: A Risk-Based Approach to Monitoring","document_id":"FDA-2011-D-0597-0062"},{"title":"Agency Information Collection Activities; Proposed Collection;\nComment Request; Oversight of Clinical Investigations: A Risk-Based\nApproach to Monitoring","document_id":"FDA-2011-D-0597-0060"},{"title":"Agency Information Collection Activities; Announcement of Office \nof Management and Budget Approvals","document_id":"FDA-2011-D-0597-0059"},{"title":"Agency Information Collection Activities; Submission for Office of\nManagement and Budget Review; Guidance for Industry on Oversight of\nClinical Investigations: A Risk-Based Approach to Monitoring","document_id":"FDA-2011-D-0597-0058"},{"title":"Agency Information Collection Activities; Proposed Collection;\nComment Request; Guidance for Industry on Oversight of Clinical\nInvestigations: A Risk-Based Approach To Monitoring","document_id":"FDA-2011-D-0597-0055"},{"title":"Guidance for Industry on Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring","document_id":"FDA-2011-D-0597-0053"},{"title":"Guidance for Industry on Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring; Availability","document_id":"FDA-2011-D-0597-0052"},{"title":"Agency Information Collection Activities; Proposals, Submissions, and Approvals: Draft Guidance for Industry; Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring","document_id":"FDA-2011-D-0597-0050"},{"title":"Draft Guidance for Industry; Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring","document_id":"FDA-2011-D-0597-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2011-D-0597","supporting_documents_count":11,"docket_id":"FDA-2011-D-0597","regulation_id_number":null,"title":"Industry on Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring","checked_regulationsdotgov_at":"2013-08-27T08:06:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":48173,"subtype":null,"title":"Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring; Availability","toc_doc":"Oversight of Clinical Investigations, A Risk-Based Approach to Monitoring","toc_subject":"Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}