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To be associated with an adverse event(s), for reporting to the relevant UP AEC Generic scientific use details: Project title:AEC approval #:Location (animal facility):Chief Investigator:Crops performed
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How to fill out reporting unexpected adverse events

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Step 1: Identify the unexpected adverse event and gather all relevant information.
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Step 2: Determine if the event meets the criteria for reporting, such as being unexpected and related to a product or drug.
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Step 3: Complete the adverse event report form, providing detailed information about the event, such as date, time, location, severity, and impact.
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Step 4: Include any supporting documents, such as medical records or laboratory results.
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Step 5: Submit the completed report to the appropriate regulatory agency or organization according to their guidelines and procedures.
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Step 6: Follow up with any additional requests or inquiries from the regulatory agency or organization regarding the reported event.
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Step 7: Keep a record of the reported event and any correspondence related to it for future reference or audits.

Who needs reporting unexpected adverse events?

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Healthcare professionals
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Pharmacists
03
Patients
04
Caregivers
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Manufacturers of drugs or medical devices
06
Health regulatory agencies
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Researchers and scientists

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Reporting unexpected adverse events refers to the process of notifying relevant authorities or stakeholders about harmful occurrences that were not anticipated during clinical trials or after the release of a drug or medical device.
Typically, manufacturers, sponsors of clinical trials, and healthcare professionals who witness or become aware of such events are required to file reports on unexpected adverse events.
To fill out a report on unexpected adverse events, one must provide detailed information about the event, including patient identifiers, a description of the event, the relationship to the product, and any relevant medical history or treatment details.
The purpose of reporting unexpected adverse events is to identify potential safety issues, enhance patient safety, and ensure that appropriate actions are taken to mitigate risks associated with medical products.
The information that must be reported includes patient demographics, details of the adverse event, product involved, date of occurrence, and any prior medical history relevant to the event.
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