*** UPIRTSO Reporting Policy (formerly SAE) ***

• Reporting Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO) Policy
• Reporting Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO) Procedure
• Examples of UPIRTSO and Non-UPIRTSO (PowerPoint)
• Frequently Asked Questions
• OHRP Guidance on Reporting Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO)
• UPIRTSO Education and Training (PowerPoint)

Related Definitions:

Unanticipated Problem Involving Risk to Subjects or Others (UPIRTSO): Mayo Clinic's IRB defines unanticipated problem/event involving risk to subjects or others (UPIRTSO) as any problem or event that was 1) serious; 2) unanticipated; AND 3) at least possibly related to the research procedures.

Serious: Serious problems/events can be well defined and include death; life threatening adverse experience; hospitalization: inpatient, new, or prolonged; disability/incapacity: persistent or significant; birth defect/anomaly; and/or per protocol OR may be problems/events that in the opinion of the local Investigator may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data.

Unanticipated: (unexpected) problems/events are those that are not already described as potential risks in the consent form, not listed in the Investigator's Brochure, or not part of an underlying disease. A problem/event is "unanticipated" when it was unforeseeable at the time of its occurrence. A problem/event is "unanticipated" when it occurs at an increased frequency or at an increased severity than expected.

Related: A problem/event is "related" if it is possibly, probably or definitely related to the research study.