Adverse Event

Any unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (Unanticipated Problems Involving Risk and Adverse Events Guidance, OHRP, 2007).

A significant adverse event is an adverse event that is unexpected and substantively impacts the human subjects.

A serious adverse event (Unanticipated Problems Involving Risk Adverse Events Guidance, OHRP, 2007) is any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria:

(1) results in death;

(2) is life-threatening;

(3) requires inpatient hospitalization or prolongation of existing hospitalization;

(4) results in a persistent or significant disability/incapacity;

(5) results in a congenital anomaly/birth defect; or

(6) 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 in this definition.