A SUSAR is a suspected unexpected adverse event or adverse reaction that results in death, is life-threatening*, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
All sites relating to this drug being used will receive various documents such as this that need to be handled in a specific way to make sure all proper parties are informed and know how to take action.
