483
University of Texas at Arlington IRBFDA 483 - University of Texas at Arlington IRB - June 11, 2019
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Record Details
An FDA inspection of the University of Texas at Arlington IRB identified a significant compliance issue. The Institutional Review Board failed to ensure that informed consent documents included a statement notifying subjects of the possibility of FDA inspection of their study records. This deficiency was noted across multiple reviewed protocols.
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ID · 5c0098a1-6a8c-42a4-bf03-38bf2e3bac6d