Reportable Events

Institutional Review Board

Reportable Events

The Investigator must report certain events to the Parkview Health Institutional Review Board (IRB) that are related or possibly related to the study.  Reportable events include serious, unanticipated adverse events and device effects, and other serious unanticipated problems.  The PH IRB reviews these events to ensure the safety and welfare of subjects. 

IRB Reportable Events Policy

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