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GUIDANCE DOCUMENT

A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry March 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers

Docket Number:
FDA-2019-D-0362
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Office of Good Clinical Practice
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” The draft guidance provides information to sponsors on risk-based approaches to monitoring of investigational studies of human drug and biological products, medical devices, and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.


Submit Comments

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.