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During the triage phase of a potential adverse event report, it is important to determine if the "four elements" of a valid individual case safety report are present: (1) an identifiable patient, (2) an identifiable reporter, (3) a suspect drug, and (4) an adverse event.
Triage systems vary dramatically based on a variety of factors, and can follow specific, measurable metrics, like trauma scoring systems, or can be based on the medical opinion of the provider. [6] Triage is an imperfect practice, and can be largely subjective, especially when based on general opinion rather than a score.
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
The program is an outgrowth of the 1986 National Childhood Vaccine Injury Act (NCVIA), which requires health care providers to report: Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine. Any event listed in the Reportable Events Table that occurs within the specified time period after vaccination.
Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are merely documented ...
He said: "A Significant Adverse Event (SAE) panel, made up of a number of experts including an external clinician, will carry out the careful review using the normal processes and the report will ...
In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose Results in death; Is life-threatening; Requires inpatient hospitalization or causes prolongation of existing hospitalization; Results in persistent or significant disability/incapacity
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