How can a sponsor know whether an IRB has been inspected by FDA, and the results of the inspection?

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The CDER, maintains an inventory of the IRBs that have been inspected, including dates of inspection and classification. The division recently began including the results of inspections assigned by the CBER and the CDRH. This information is available through Freedom of Information Act (FOIA) procedures. Once an investigational file has been closed, the correspondence between FDA and the IRB and the narrative inspectional report are also available under FOI.

About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management

Stephanie has over 20 years of clinical research experience working from the site, CRO and sponsor perspectives. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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