Shortly before shift change, a patient with cirrhosis is admitted with spontaneous bacterial peritonitis, a dangerous but treatable abdominal infection. The admitting provider orders the appropriate ...
Per federal regulations, University and affiliate researchers must notify the IRB of unanticipated problems that involve risks to participants or others (henceforth referenced as Unanticipated ...
Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB IRB policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...
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