- Issued by:
Guidance Issuing OfficeOffice of Global Regulatory Operations and Policy, Office of Regulatory AffairsOffice of Medical Products and Tobacco, Office of Special Medical Programs, Office of Good Clinical PracticeOffice of Medical Products and Tobacco, Center for Drug Evaluation and ResearchOffice of Medical Products and Tobacco, Center for Devices and Radiological HealthOffice of Medical Products and Tobacco, Center for Biologics Evaluation and Research
This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, 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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.