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Human Research Ethics Committee Adverse Event Form Please complete this form and email it to ResearchCompliance UNIMA.edu.AU upon notification of an adverse event regarding your research. SECTION
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What is including serious adverse event?
Including serious adverse event refers to reporting any undesirable medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or any other event that may jeopardize the patient or require medical intervention.
Who is required to file including serious adverse event?
The responsibility of filing including serious adverse event lies with the healthcare professionals, researchers, clinical trial sponsors, pharmaceutical companies, and anyone involved in the monitoring and reporting of adverse events.
How to fill out including serious adverse event?
To fill out including serious adverse event, accurate and detailed information about the event should be documented, including patient demographics, medical history, description of the event, its severity, treatment received, and any relevant laboratory data or diagnostic information.
What is the purpose of including serious adverse event?
The purpose of including serious adverse event is to monitor and assess the safety of medical interventions, treatments, medications, or devices. It helps identify potential risks, evaluate the benefit-risk ratio, and ensure patient safety.
What information must be reported on including serious adverse event?
When reporting including serious adverse event, essential information includes patient identifiers, description of the event, dates of occurrence, severity, outcome, treatment given, related medications or devices, and any contributing factors or pre-existing conditions.
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