Adverse Event Form
The investigator must report all incidents of injury or other adverse events experienced by subjects to the St. Catherine University IRB office. An adverse event is defined as any unintended adverse experience associated with the study materials or study procedures, that results in an unplanned medical or psychological assessment or treatment, or changes the risk to subjects. A written report should be submitted to the St. Catherine University IRB office within 48 hours of the investigators’ knowledge of the event. Use the Adverse Event Form to report the event. The IRB may require additional reports until the incident is resolved.