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Comprehensive report detailing serious adverse events in clinical studies, including patient data, drug information, and causality assessment for effective review.
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A suspected unexpected serious adverse event (SUSAR) is an adverse event that is both serious and unexpected, meaning it is not listed in the product's labeling and poses a significant risk to patient safety.
The sponsor of the clinical trial or study is required to file reports of suspected unexpected serious adverse events to regulatory authorities.
To fill out a SUSAR report, provide comprehensive details about the event, the patient, the investigational product, and the outcome. Follow the specific format and guidelines set by the relevant regulatory authority.
The purpose of reporting SUSARs is to ensure patient safety by monitoring the safety profile of a product and to implement necessary regulatory actions to mitigate risks.
Information that must be reported includes patient demographics, details of the adverse event, the time frame, any treatment provided, and an assessment of the relationship between the event and the investigational product.
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