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GUIDANCE DOCUMENT

Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Guidance for Industry August 2013

Download the Final Guidance Document
Final Level 2 Revised Guidance
Docket Number:
FDA-2011-D-0597
Issued by:
Guidance Issuing Office
Office of Inspections and Investigations
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice

OMB Control Number: 0910-0014

Expiration Date: 03/31/2025

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

Submit Comments Online

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:

Dockets Management
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-2011-D-0597.

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