Glossary Term

Unanticipated Problem (UP)

Data & Safety

Also known as: UP, UPIRTSO, unanticipated problems involving risks to subjects or others

Any incident, experience, or outcome that is unexpected, related or possibly related to participation, and suggests greater risk of harm than was previously known.

Under OHRP guidance, UPs must be reported promptly to the IRB and, when criteria are met, to OHRP and the federal department supporting the research. UPs include but are not limited to adverse events.

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