Drug Safety Associate Question:
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Tell me when do you consider an event to be serious?
Answer:
If an event is associated with any one of the following, it is considered to be serious
☛ Death
☛ Life threatening
☛ Hospitalization or prolongation of hospitalization.
☛ Congenital anomaly
☛ Disability
☛ Medically significant
☛ Death
☛ Life threatening
☛ Hospitalization or prolongation of hospitalization.
☛ Congenital anomaly
☛ Disability
☛ Medically significant
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