Event Process Flow Chart
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Reportable Events Process Flowchart IRB review of case as per SOP RR 408 Potential actions: Convened IRB review • • • • IRB Executive Chair may suspend study or require changes to eliminate immediate hazards to subjects Sponsor or PI assess the event Modify study or consent Suspend enrollment Suspend research Approve PI’s proposed changes IRB determines not reportable Inform PI of IRB decision No further action..
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