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FREQUENTLY Asked Questions
Which FDA office may an IRB contact to determine whether an investigational new drug application (IND) or investigational device exemption (IDE) is required for a study of a test article?
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About the Author
Director of Project Management
Stephanie has over 20 years of clinical research experience working from the site, CRO, and sponsor perspectives.
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contact the Center for Drug Evaluation and Research (CDER), Office of Communications, Division of Drug Information at (301) 796-3400
contact the Center for Biologics Evaluation and Research (CBER), Office of Communication, Outreach and Development, at (800)-835-4709 or (301) 827-1800.
contact the Investigational Device Exemption (IDE) Staff, Office of Device Evaluation, Center for Devices and Radiological Health (CDRH), at (301) 796-5640.
Investigational Device Exemption (IDE)
Institutional Review Boards (IRB)
Investigational New Drug Application (IND)
Is the purpose of the IRB review of informed consent to protect the institution or the subject?
Must an institution establish its own IRB?
Do the FDA regulations permit non-local IRB review?
To what extent is the IRB expected to actively audit and monitor the performance of the investigator with respect to human subject protection issues?
Can subjects be screened prior to initiation of a clinical study to determine eligibility? Is informed consent required for screening?
May the IRB use alternate members?
What type of advertising must be reviewed by the IRB?
How can a sponsor know whether an IRB has been inspected by FDA, and the results of the inspection?
What happens when a study subject at one institution is admitted to a second institution that is designated as an extension of the research milieu?
When are IRB inspections conducted?
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