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Version 07/15/11 VALENCIA COLLEGE Human Research Protection (HIP) Institutional Review Board (IRB) IRB Adverse Event/Unanticipated Problem/Increased Risk Report Form (for Internal and External Investigators)
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What is irb adverse eventunanticip?
The IRB adverse event unanticipated refers to an unexpected occurrence or experience during a research study that requires reporting to the Institutional Review Board (IRB).
Who is required to file irb adverse eventunanticip?
Researchers conducting a study that falls under the purview of an IRB are required to file an IRB adverse event unanticipated report.
How to fill out irb adverse eventunanticip?
To fill out an IRB adverse event unanticipated report, researchers typically need to provide details about the event, such as the nature of the event, when it occurred, its impact on the subjects, and any actions taken in response.
What is the purpose of irb adverse eventunanticip?
The purpose of the IRB adverse event unanticipated report is to ensure the protection of human subjects involved in research studies by promptly identifying and addressing unexpected events or experiences.
What information must be reported on irb adverse eventunanticip?
The information that must be reported on an IRB adverse event unanticipated report includes the nature of the event, date and time of occurrence, participants affected, severity of the event, potential causes, and any actions taken or planned to mitigate the event.
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