FDA 483 - Trinity Hospital IRB # 1 - October 11, 2019

Trinity Hospital IRB # 1 in Minot, ND, received a Form 483 with two observations during an FDA inspection. The observations highlight that the Institutional Review Board failed to adequately review research protocols and did not consistently maintain a quorum at convened meetings for non-expedited research. These findings indicate non-compliance with regulatory requirements for IRB operations.