483
Memorial Hospital of Rhode Island IRBMemorial Hospital of Rhode Island IRB – FDA 483, Apr 17, 2019
Record Details
An FDA inspection of Memorial Hospital of Rhode Island IRB in Pawtucket, RI, identified a significant deficiency in the maintenance of Institutional Review Board (IRB) meeting minutes. The IRB failed to adequately document voting actions for FDA-regulated studies, indicating a lapse in record-keeping procedures. This observation highlights a need for improved detail in recording IRB decisions and votes.
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