SERIOUS ADVERSE EVENTS


A Serious Adverse Event (SAE) is any adverse event that:

  • results in death;
     
  • is life-threatening (places the subject at immediate risk of death from the event as it occurred);
     
  • results in inpatient hospitalization or prolongation of existing hospitalization;
     
  • results in a persistent or significant disability/incapacity;
     
  • results in a congenital anomaly/birth defect; or
     
  • any event that, based upon appropriate medical judgment, may jeopardize the subject's health and may require medical or surgical intervention to prevent one of the other outcomes listed above. For example:
     
    • allergic bronchospasm requiring intensive treatment in the emergency room or at home,
       
    • blood dyscrasias or convulsions that do not result in inpatient hospitalization, or
       
    • the development of drug dependency or drug abuse.
       

SAEs, including death should be reported promptly to the IRB only if the event qualifies as an Unanticipated Problem.