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View Full Version : Characteristics of a good quality adverse event case report



TomHsiung
Sat 12th January '13, 5:58pm
Characteristics of a good quality adverse event case report include:



date of initiation of the suspected drug,
detailed description(s) of the adverse event(s),
time to the onset of signs and symptoms of the event,
list of suspected and/or concomitant drugs including over-the-counter medications, and dietary supplements,
patient demographics (e.g., age, sex) ,
baseline medical condition, comorbid conditions, and relevant family history of disease,
documentation of diagnosis of events,
results of any laboratory or diagnostic medical imaging, and
clinical outcome and actions taken with the suspected drug(s).