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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
Sr. Director of Clinical Operations
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 the non-local IRB obtain knowledge of local community attitudes, conditions surrounding the conduct of the research, and the continuing status of the research?
Are research sponsors permitted to contact the Institutional Review Board (IRB) directly?
The informed consent regulations require the consent document to include a statement that notes the possibility that FDA may inspect the records. Is this statement a waiver of the subject's legal right to privacy?
Must an investigator's brochure be included in the documentation when an IRB reviews an investigational drug study?
May informed consent be obtained by telephone from a legally authorized representative?
Are there any regulations that require clinical investigators to report to the IRB when a study has been completed?
What are the reporting requirements for screening tests?
What type of advertising must be reviewed by the IRB?
How does a sponsor submit information to FDA about a foreign clinical study that was not conducted under an IND?
If an IRB uses a standard "fill-in-the-blank" consent format, does the IRB need to review the filled-out form for each study?
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