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

DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER) Ann Meeker O’Connell at 301-7963150, (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301827-1800, or (CDRH) Chrissy Cochran at 301-796-5490.

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) August 2011 Procedural

Monitoring-Guidance.doc 8/24/2011

Guidance for Industry
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
Additional copies are available from: Office of Communications Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm. 2201 Silver Spring, MD 20993-0002 (Tel) 301-796-3400; (Fax) 301-847-8714; (E-mail) druginfo@fda.hhs.gov http://www.fda.gov/RegulatoryInformation/Guidances/default.htmand/or

Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 800-835-4709 or 301-827-1800; (E-mail) ocod@fda.hhs.govhttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default. htm

Office of Communication, Education and Radiation Programs Division of Small Manufacturers, International and Consumer Assistance Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Ave., Bldg. 66, rm. 4613 Silver Spring, MD 20993-0002 (Tel) 800-638-2041 or 301-796-7100; (Fax) 301-847-8149; (E-mail) dsmica@fda.hhs.gov http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm

U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) August 2011 Procedural

Monitoring-Guidance.doc 8/24/2011

Draft — Not for Implementation TABLE OF CONTENTS

I. II.
A. B. C. D.

INTRODUCTION............................................................................................................. 1 BACKGROUND ............................................................................................................... 1
Current Monitoring Practices ...................................................................................................... 3 Other FDA Guidance on Monitoring ........................................................................................... 4 Rationale for Facilitating Risk-Based Monitoring……………………………………………...4 Steps FDA is Taking to Facilitate Wider Use of Alternative Monitoring Approaches............ 5

III. IV.
A.

FACTORS THAT INFLUENCE STUDY QUALITY AND INTEGRITY................. 6 GENERAL MONITORING RECOMMENDATIONS ................................................ 7
Types of Monitoring ...................................................................................................................... 7 1. On-Site Monitoring