United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-08-07 article Notices D09002ee1c7fb26af D09002ee1c7fb272e United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 78 FR 48173 https://www.govinfo.gov/app/details/FR-2013-08-07/2013-19004 2013-19004 fr07au13-63 4160-01-P Docket No. FDA-2011-D-0597 https://www.govinfo.gov/app/details/FR-2013-08-07/2013-19004 https://www.govinfo.gov/content/pkg/FR-2013-08-07/html/2013-19004.htm https://www.govinfo.gov/content/pkg/FR-2013-08-07/pdf/2013-19004.pdf 2 p. 48173 48174 78 FR 48173 Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring; Availability; Federal Register Vol. 78, Issue NOTICE 2013-19004 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2011-D-0597 4160-01-P 2013-19004 Notice.

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.

Submit either electronic or written comments on Agency guidances at any time. Ann Meeker-O'Connell, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 5356, Silver Spring, MD 20993-0002, 301- 796-7615; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210; or Linda Godfrey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3446, Silver Spring, MD 20993-0002, 301-796-5490. Guidance for Industry; Availability: Oversight of Clinical Investigations, A Risk-Based Approach to Monitoring , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceREgulatoryInformation/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm http://www.regulations.gov Vol. 78, no. 152 Office of the Federal Register, National Archives and Records Administration 2013-08-07 continuing daily deposited born digital 264 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-08-07 P0b002ee185c8d3a0 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07au13 https://www.govinfo.gov/app/details/FR-2013-08-07 https://www.govinfo.gov/content/pkg/FR-2013-08-07/pdf/FR-2013-08-07.pdf https://www.govinfo.gov/content/pkg/FR-2013-08-07/xml/FR-2013-08-07.xml fdlp 48025 48281 DGPO 2013-08-07 2024-06-03 FR-2013-08-07 machine generated eng FR FR-2013-08-07 78 152