A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers
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Guidance Issuing OfficeOffice of Regulatory AffairsOffice of Good Clinical PracticeCenter for Drug Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” The draft guidance provides information to sponsors on risk-based approaches to monitoring of investigational studies of human drug and biological products, medical devices, and combinations thereof. This guidance expands on the guidance for industry entitled “Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” (August 2013) (the RBM Guidance) by providing additional guidance to facilitate sponsors' implementation of risk-based monitoring.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-0362.