Drug Safety Associate Question:
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Tell me some Data Elements In Icsr?
Answer:
Patient demographics: Age, gender and race.
Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and indication. Adverse event details: Event, event onset date, seriousness criterion, event end date and latency.
Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and indication. Adverse event details: Event, event onset date, seriousness criterion, event end date and latency.
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