483
Mt. Sinai Hospital Medical Center IRBFDA 483 - Mt. Sinai Hospital Medical Center IRB - May 26, 2023
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Record Details
An FDA inspection of Mt. Sinai Hospital Medical Center IRB in Chicago, IL, revealed a significant deficiency in maintaining adequate records. The Institutional Review Board failed to prepare and maintain detailed minutes for several meetings where FDA-regulated studies were reviewed. This indicates a serious lapse in documentation practices for research oversight.
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ID · a9ff1e68-fbb3-4514-b2f9-e129b60459f2