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UPI RSO (Unanticipated Problems Involving Risks to Participants or Others) Checklist (Is the Report a UPI RSO?) (This form applies to external and local AE's and noncompliance) Memo Date: ___Event:

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What is unanticipated problems involving risks?

Unanticipated problems involving risks are events that were not foreseen during the planning stages of a study and have the potential to harm participants or affect the integrity of the study.

Who is required to file unanticipated problems involving risks?

Researchers conducting the study are required to file unanticipated problems involving risks with the appropriate regulatory bodies.

How to fill out unanticipated problems involving risks?

To fill out unanticipated problems involving risks, researchers need to provide a detailed description of the event, its impact on participants, and any actions taken to address the issue.

What is the purpose of unanticipated problems involving risks?

The purpose of reporting unanticipated problems involving risks is to ensure the safety of study participants and maintain the integrity of the research.

What information must be reported on unanticipated problems involving risks?

Researchers must report details of the event, its impact, actions taken, and any changes made to the study protocol.

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