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SERIOUS ADVERSE EVENT REPORTING FORM Initial Reporting: Once you have become aware of a SAE or SUGAR, please email this form to the BALI Trial Office (BTO) email: Bali Paul.ac.UK within 24 hours of

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What is serious adverse event reporting?

Serious adverse event reporting is the process of reporting any adverse events that result in death, hospitalization, life-threatening situations, disability, or other serious outcomes in relation to a product or medical intervention.

Who is required to file serious adverse event reporting?

Manufacturers, distributors, importers, and certain healthcare providers are required to file serious adverse event reporting.

How to fill out serious adverse event reporting?

Serious adverse event reporting can be filled out by providing detailed information about the event, including the date of occurrence, the affected individual, the type of event, and any known contributing factors.

What is the purpose of serious adverse event reporting?

The purpose of serious adverse event reporting is to monitor the safety and effectiveness of products and medical interventions, identify potential risks, and take appropriate regulatory action to protect public health.

What information must be reported on serious adverse event reporting?

Information that must be reported on serious adverse event reporting includes details about the affected individual, the event itself, any contributing factors, and the product or intervention involved.