Adverse Events

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