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Local Serious Adverse Event (SAE) Report Submission: Complete this report for each adverse event that is serious, has a definite or possible causal relationship to the study intervention and/or is
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Access the adverse events form provided by the relevant authority or organization.
02
Fill in the required information such as the date of the event, the type of adverse event, severity level, and any contributing factors.
03
Provide details about the individual who experienced the adverse event, including their name, age, and any relevant medical history.
04
Describe the event in detail, including what happened, when it occurred, and any actions taken in response.
05
Submit the completed adverse events form according to the designated procedure.

Who needs adverse events that are?

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Healthcare professionals
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Pharmaceutical companies
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Medical device manufacturers
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Regulatory agencies
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Adverse events are any unexpected or harmful events that occur during a study or medical treatment.
Healthcare providers, researchers, and pharmaceutical companies are required to file adverse events.
Adverse events are typically filled out using specific forms provided by regulatory agencies or study protocols.
The purpose of adverse events reporting is to monitor the safety of treatments, drugs, and medical devices.
Information such as the date of the event, severity, outcome, and any actions taken must be reported on adverse events.
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