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Local Serious Adverse Event Form Human Subjects ResearchNaval Medical Center Portsmouth, VA Contact Clinical Investigation Department at (757) 9535939INSTRUCTIONSSerious adverse events (SAE's) are
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Local serious adverse event refers to any unexpected medical occurrence, including side effects or illnesses, that happen during a clinical trial and require immediate reporting.
The investigator or the sponsor of the clinical trial is required to file local serious adverse event reports.
Local serious adverse event reports are typically filled out using specific forms provided by the regulatory authorities or institutional review boards.
The purpose of reporting local serious adverse events is to ensure the safety of participants in clinical trials and to gather data on the potential risks and benefits of the investigational product.
Information such as the nature of the adverse event, its severity, the timeline of occurrence, any actions taken in response, and the outcome must be reported on local serious adverse event reports.
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