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Institutional Review Board Clayton State University UC149 2000 Clayton State Blvd, Morrow, GA 30260 (678) 4664979 (678) 4664190Unanticipated Problems and Adverse Events Report Form(Check One) Dr.
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How to fill out unanticipated problems and adverse

01
Identify and define what constitutes an unanticipated problem or adverse event
02
Report the problem or event to the appropriate parties
03
Document all relevant details and information related to the problem or event
04
Develop and implement a plan to address and resolve the issue
05
Follow up and monitor the situation to ensure it has been resolved effectively

Who needs unanticipated problems and adverse?

01
Researchers conducting clinical trials or experiments
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Healthcare professionals working with patients
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Regulatory agencies overseeing medical devices or pharmaceuticals

What is Unanticipated Problems and Adverse Events Report Form?

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Unanticipated problems and adverse events refer to incidents in research that were not expected and that may negatively affect the safety, rights, or welfare of participants or others involved in the study.
Investigators and institutions conducting research involving human subjects are typically required to file reports of unanticipated problems and adverse events to appropriate regulatory bodies, such as Institutional Review Boards (IRBs) or Ethics Committees.
To fill out a report for unanticipated problems and adverse events, you typically need to include details such as the nature of the event, its outcome, a timeline, investigation results, and steps that will be taken to prevent future occurrences.
The purpose of reporting unanticipated problems and adverse events is to ensure participant safety, improve study protocols, and maintain compliance with ethical and regulatory standards.
Key information that must be reported includes a description of the event, timing, affected participants, any corrective actions taken, and future risk mitigation strategies.
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