Adverse Events

Define adverse event, serious adverse event, and unanticipated problem ¿ Recognize and categorize adverse events, serious adverse events, and unanticipated problems ¿ Identify investigator and study team member responsibilities in recognizing, addressing, and reporting adverse events, serious adverse events, and unanticipated problems ¿ Define reporting responsibilities of the investigator, study team and institution to the FDA, funding agencies, and the DUHS IRB