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Adverse Event Monitoring, Investigation, and Response in the Context of Index TestingStandard Operating Procedure January 2021Suggested Citation: Epic. Standard Operating Procedure for Adverse Event
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Open the adverse event monitoring form
02
Read the instructions and guidelines carefully
03
Enter the relevant information such as patient details, date and time of adverse event, and description of the event
04
Provide any additional details or documentation if required
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Ensure the accuracy and completeness of the entered information
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Submit the filled out form to the designated authority for monitoring adverse events

Who needs for adverse event monitoring?

01
Pharmaceutical companies
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Biotechnology companies
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Healthcare providers
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Clinical research organizations
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Regulatory agencies
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Drug safety departments
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Healthcare professionals

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Adverse event monitoring is the process of tracking and reporting any negative or unexpected events associated with a medical product or treatment.
Healthcare professionals, patients, and pharmaceutical companies are all required to file reports for adverse event monitoring.
To fill out for adverse event monitoring, individuals can typically submit reports online through a designated reporting system or contact the appropriate regulatory agency.
The purpose of adverse event monitoring is to ensure the safety and efficacy of medical products and treatments by detecting and assessing any potential risks or side effects.
Reports for adverse event monitoring should include details such as the patient's demographics, the medical product or treatment involved, the adverse event experienced, and any relevant medical history.
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