The University IRB follows federal regulations and guidance for reporting unanticipated problems involving risks to participants or others (Unanticipated Problems), serious or continuing noncompliance ...
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 ...
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 ...
Follow the step-by-step instructions below to successfully maintain and close a protocol with the IRB. Instructions below include information about continuing reviews, amendments, event reporting (new ...
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