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AIRS v2.1 User GuideRevised June 2016 1Contents 1.0. Introduction to the DAMS Adverse Event Reporting System (AIRS) .................................... 3 2.0. Adverse Events (AE's) .............................................................................................................................
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How to fill out an adverse event capture

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How to fill out an adverse event capture

01
To fill out an adverse event capture, follow these steps:
02
Start by gathering all relevant information about the adverse event, such as the date and time of occurrence, the individuals involved, and any known contributing factors.
03
Begin the capture by clearly stating the nature of the adverse event, providing a concise description of what occurred.
04
Document any immediate actions taken to address the adverse event, including any interventions or treatments provided.
05
Record any observations or findings related to the adverse event, such as physical symptoms or changes in behavior.
06
Note any potential causes or contributing factors that may have led to the adverse event, including environmental conditions or medication interactions.
07
Include any additional relevant information, such as follow-up plans or recommendations for preventing similar events in the future.
08
Review the completed adverse event capture for accuracy and completeness before submitting it for further analysis or reporting.

Who needs an adverse event capture?

01
An adverse event capture is needed by various stakeholders, including:
02
- Healthcare providers: To document and report adverse events that occur within their practice or organization.
03
- Pharmaceutical companies: To track and monitor adverse events related to their products or medications.
04
- Regulatory agencies: To collect data on adverse events for surveillance and safety monitoring purposes.
05
- Researchers: To study adverse events and identify patterns or trends that can inform medical interventions and public health policies.
06
- Patients or their caregivers: To report adverse events experienced during medical treatments or medication use.
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An adverse event capture is a process of documenting and reporting any unwanted or harmful events related to a medical product or device.
Healthcare providers, manufacturers, and consumers are required to file an adverse event capture.
An adverse event capture form typically requires information such as the product involved, details of the event, patient information, and contact details.
The purpose of an adverse event capture is to monitor the safety and effectiveness of medical products and devices and to protect public health.
The information reported on an adverse event capture includes details of the event, the medical product involved, patient information, and contact details of the reporter.
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