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Guide for Reporting Unanticipated Problems, Protocol Deviations and Other Events to the IRB Administration Office at Wayne State University (WSU) Principal investigators must report any of the following
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How to fill out unanticipated problems and event
How to fill out unanticipated problems and event
01
Identify the unanticipated problem or event that occurred.
02
Document the specific details surrounding the problem or event.
03
Assess the potential impact or consequences of the problem or event on the study.
04
Determine if any actions need to be taken to address the problem or event.
05
Report the problem or event to the appropriate parties, such as the Institutional Review Board or sponsor.
Who needs unanticipated problems and event?
01
Researchers conducting clinical trials or research studies.
02
Institutional Review Boards (IRBs) overseeing research studies.
03
Study sponsors or funding agencies.
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What is unanticipated problems and event?
Unanticipated problems and events are unexpected occurrences that may have an impact on research subjects.
Who is required to file unanticipated problems and event?
Researchers and sponsors are required to file unanticipated problems and events.
How to fill out unanticipated problems and event?
To fill out unanticipated problems and events, researchers need to provide detailed information about the unexpected occurrence and its impact on research subjects.
What is the purpose of unanticipated problems and event?
The purpose of reporting unanticipated problems and events is to ensure the safety and well-being of research subjects.
What information must be reported on unanticipated problems and event?
Information that must be reported on unanticipated problems and events includes the nature of the occurrence, its impact on research subjects, and any actions taken in response.
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