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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)
If a site uses a receptionist to screen subjects for studies, must the script he/she uses be reviewed by the IRB?
Must an investigator's brochure be included in the documentation when an IRB reviews an investigational drug study?
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?
Must foreign clinical study sites in a multinational study that includes domestic sites be conducted under an IND?
When a secondary research facility is used, how should informed research consent be documented?
What are the reporting requirements for screening tests?
Are there any screening procedures that could be performed without first obtaining consent?
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?
What happens when a study subject at one institution is admitted to a second institution for a reasonably foreseeable reason and as an anticipated part of the study protocol?
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