Note: SAEs, Unanticipated AEs, and Unanticipated Problem Involving Risk to Participants or Others must be reported to the IRB within 5 business days as "reportable new information."
Adverse Event (AE): An adverse event is an undesirable and unintended event occurring as a result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy). It also includes any untoward or 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. Serious Adverse Event (SAE): Events are classified as serious if they meet any of the following criteria:
- Results in death or any life threatening event that places the subject at immediate risk of death from the event as it occurred.
- Any event that requires or prolongs in-patient hospitalization.
- Any event that results in persistent or significant disability/incapacity.
- Any congenital anomaly/birth defect diagnosed in a child of a subject who participated in the study and received study drug.
- Other medically important events that in the opinion of the investigator may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above.
Unanticipated AE: Any adverse experience, the frequency or severity of which is not consistent with the current consent form or investigator brochure.
Unanticipated Problem Involving Risk to Participants or Others: Any unanticipated event involving any aspect of a research study involving anyone (participants, research staff, or others not directly involved in the research) that increases the risk to the person involved.
DHHS Guidance: Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events