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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)
When are IRB inspections conducted?
Can subjects be screened prior to initiation of a clinical study to determine eligibility? Is informed consent required for screening?
What is an "assurance" or a "multiple project assurance," and are assurances required by the FDA?
Which party is responsible for maintaining and communicating confidential medical records and information during a study?
Are research sponsors obligated to determine IRB compliance with regulations?
Are research sponsors permitted to contact the Institutional Review Board (IRB) directly?
Do Radioactive Drug Research Committees (RDRCs) have authority to approve initial clinical studies in lieu of an IND?
What is expedited review?
Must an investigator's brochure be included in the documentation when an IRB reviews an investigational drug study?
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?
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