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SOUTHERN ILLINOIS UNIVERSITY EDWARDSVILLE ADVERSE EVENT/UNANTICIPATED PROBLEM REPORT Researchers must report to the Southern Illinois University (SIDE) Institutional Review Board (IRB) all incidents
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How to fill out adverse eventunanticipated problem report
How to fill out adverse eventunanticipated problem report
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Step 1: Gather all relevant information related to the adverse event or unanticipated problem.
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Step 2: Open the adverse event/unanticipated problem report form.
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Step 3: Fill out the identification section, which includes the date, time, and location of the event.
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Step 4: Provide a detailed description of the adverse event or unanticipated problem, including any contributing factors or root causes.
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Step 5: Include any actions taken to address the event or problem, such as medical interventions or corrective measures.
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Step 6: Indicate whether the event or problem resulted in any harm or significant risk to the individuals involved.
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Step 7: Provide contact information for the person filling out the report in case further clarification is needed.
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Step 8: Review the completed form for accuracy and completeness.
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Step 9: Submit the adverse event/unanticipated problem report to the appropriate authority or organization as specified.
Who needs adverse eventunanticipated problem report?
01
Adverse event/unanticipated problem reports are needed by healthcare professionals, researchers, regulatory agencies, and organizations involved in patient safety and quality improvement.
02
They play a crucial role in identifying potential risks, conducting investigations, implementing preventive measures, and improving the overall safety and quality of healthcare services.
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What is adverse event/unanticipated problem report?
Adverse event/unanticipated problem report is a document that provides details about any unexpected medical occurrence or issue that arises during a clinical trial or research study.
Who is required to file adverse event/unanticipated problem report?
Researchers, investigators, and sponsors involved in a clinical trial or research study are required to file adverse event/unanticipated problem reports.
How to fill out adverse event/unanticipated problem report?
Adverse event/unanticipated problem reports are typically filled out by providing detailed information about the event, including the date and time of occurrence, description of the event, impact on the study participants, and any actions taken.
What is the purpose of adverse event/unanticipated problem report?
The purpose of adverse event/unanticipated problem reports is to ensure the safety and well-being of study participants, as well as to maintain the integrity and validity of the research study.
What information must be reported on adverse event/unanticipated problem report?
Information that must be reported on an adverse event/unanticipated problem report includes the date and time of the event, description of the event, severity of the event, relationship to the study intervention, actions taken, and impact on study participants.
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