Serious Adverse Event

Any research-related event (occurring at any dose or level of intervention) that results in any of the following outcomes:

• Death (report within 2 business days);
• Life-threatening event (report within 2 business days);
• Inpatient hospitalization or prolongation of existing hospitalization (report within 5 business days);
• A persistent or significant disability/incapacity (report within 5 business days);
• Or a congenital anomaly/birth defect (report within 5 business days); OR
• Any event that, when based upon the judgment of the principal investigator, jeopardizes the well-being of the human research participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.