483
Georgetown University IRBFDA 483 - Georgetown University IRB - March 11, 2020
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Record Details
Georgetown University IRB was inspected by the FDA from March 4-11, 2020, regarding its Institutional Review Board operations. The inspection revealed significant deficiencies in the preparation and maintenance of IRB meeting minutes, specifically concerning attendance records, vote tallies, and potential conflicts of interest. These issues indicate a lack of detailed documentation necessary to ensure proper oversight of research protocols.
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ID · 4722f8c4-e3d7-4442-83cf-0c475868fe7f