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This document provides a structured format for reporting Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Events (SUGAR) in clinical trials, ensuring accurate data collection.
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SAE (Serious Adverse Event) and SUSAR (Suspected Unexpected Serious Adverse Reaction) reporting involves documenting and reporting adverse events that occur during clinical trials to ensure patient safety and regulatory compliance.
Investigators and sponsors conducting clinical trials are required to file SAE and SUSAR reports to regulatory authorities.
SAE and SUSAR reporting typically involves completing specific forms provided by regulatory authorities that include details about the event, patient information, and any relevant clinical data.
The purpose of SAE and SUSAR reporting is to monitor patient safety, identify potential risks, and ensure transparency and accountability in clinical trials.
Information that must be reported includes the description of the event, patient demographics, the relationship to the study drug, and outcomes of the event.
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