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IRB # Unanticipated Problems Involving Risks to Participants or Others Worksheet: University & Medical Center Institutional Review BoardPrincipal Investigator Name: Please specify Study Title: Please
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Identify potential risks and problems that may arise unexpectedly
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Assess the severity and likelihood of each risk
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Monitor and evaluate the situation continuously to anticipate and respond to any new risks or problems
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Unanticipated problems involving risks refer to unexpected events or issues that pose a potential harm to subjects in a research study.
Researchers and investigators are required to file unanticipated problems involving risks.
To fill out unanticipated problems involving risks, researchers need to provide detailed information about the problem, its cause, and the actions taken to address it.
The purpose of unanticipated problems involving risks is to ensure the safety and well-being of research subjects in a study.
Researchers must report information about the problem, its impact on subjects, the cause of the problem, and any measures taken to address it.
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