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Aurora University Institutional Review Board ADVERSE EVENT REPORT Submit this form to the Chair of the IRB committee immediately upon occurrence of an adverse event or subject injury. Please see https://aurora.edu/academics/resources/irb/index.html
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How to fill out reporting adverse events template

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How to fill out reporting adverse events form

01
Obtain the reporting adverse events form from the appropriate organization or website.
02
Fill out the patient information section including name, date of birth, and contact information.
03
Describe the adverse event in detail including when it occurred and how it affected the patient.
04
Provide information about any medications or treatments the patient was receiving at the time of the adverse event.
05
Include any relevant medical history or conditions that may have contributed to the adverse event.
06
Sign and date the form to confirm the accuracy of the information provided.

Who needs reporting adverse events form?

01
Healthcare providers, patients, caregivers, and anyone else who has experienced or witnessed an adverse event related to a medical product or treatment.

What is Reporting Adverse Events Form?

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The reporting adverse events form is a document used to report any unexpected, harmful, or undesirable outcomes resulting from the use of a medical product or intervention.
Manufacturers, healthcare professionals, and patients are typically required to file the reporting adverse events form when they become aware of any adverse events related to medical products.
To fill out the reporting adverse events form, provide detailed information about the adverse event, including the product involved, the patient's demographic information, a description of the event, and any relevant dates.
The purpose of the reporting adverse events form is to track safety issues related to medical products and interventions, allowing regulatory agencies to assess risks and improve public safety.
Information that must be reported includes patient demographics, information about the product, a detailed description of the adverse event, the severity of the event, and any treatment given.
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