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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)
How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?
May the IRB use alternate members?
Can subjects be screened prior to initiation of a clinical study to determine eligibility? Is informed consent required for screening?
Do clinical screening procedures require IRB oversight?
21 CFR 56.115(a)(1) requires that the IRB maintain copies of "research proposals reviewed." Is the "research proposal" the same as the formal study protocol that the investigator receives from the sponsor of the research?
What may the FDA do until the IRB or parent institution takes appropriate corrective action?
Does a treatment IND/IDE require prior IRB approval?
What are the IRB's general obligations towards intraocular lens (IOL) clinical investigations? Considering the large number of IOL studies, how does an IRB approach the review of a new IOL style?
Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?
What documentation is needed to permit non-local IRB review?
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