483
Baptist Health IRB #1FDA 483 - Baptist Health IRB #1 - September 28, 2023
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Baptist Health IRB #1 in Montgomery, AL, received an FDA Form 483 with two observations concerning communication with investigators. The IRB failed to properly notify investigators regarding both the termination of research approval and the approval of proposed research activities, instead communicating with study coordinators.
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ID · d0b3b560-083e-4f5a-822e-e27bc18d212a