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INSTITUTIONAL REVIEW BOARDUnanticipated Problem (UP)/ Serious Adverse Event (SAE) Report Form For this form, a serious adverse event is any untoward medical occurrence that results in death, is life-threatening,
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Start by thoroughly analyzing the unanticipated problem and understanding its potential seriousness.
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What is unanticipated problem up serious?
An unanticipated problem up serious refers to an unexpected event that poses a serious risk to the participants of a study.
Who is required to file unanticipated problem up serious?
The principal investigator or the individual overseeing the study is required to file an unanticipated problem up serious.
How to fill out unanticipated problem up serious?
To fill out an unanticipated problem up serious report, the individual must provide detailed information about the event, its impact, and any actions taken in response.
What is the purpose of unanticipated problem up serious?
The purpose of filing an unanticipated problem up serious report is to ensure transparency, protect the participants, and promote safety in research studies.
What information must be reported on unanticipated problem up serious?
Information such as the nature of the event, the number of participants affected, the severity of the risk, and any corrective actions taken must be reported on an unanticipated problem up serious.
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