Guidance for IRBs, Clinical
Investigators, and
Sponsors
Considerations When Transferring
Clinical Investigation Oversight to
Another IRB
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Office of Good Clinical Practice
May 2014
Contains Nonbinding Recommendations
Guidance for IRBs, Clinical Investigators,
and
Sponsors
Considerations When Transferring Clinical
Investigation Oversight to Another IRB
Additional copies are available from:
Division of Drug Information, WO51-2201
Office of Communication
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-002
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Email:
DRUGINFO@fda.hhs.gov
(Tel) 301-796-3400; (Fax): 301-847-8714
and/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
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
Email:
ocod@fda.hhs.gov
(Tel) 800-835-4709 or 301-827-1800
and/or
Division of Industry and Consumer Education, WO66-5429
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-002
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
Email:
DICE@cdrh.fda.gov
(Tel) 800.638.2041 or 301- 796-7100
