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 ...
Situations may occur during implementation of a research study, after a participant withdraws or completes their participation, or after study completion that warrant assessment by Research Integrity ...
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