Self-Assessment Questions: Adverse Drug Reactions

Question 1:
Safety data is only collected during the later phases of the clinical development program for a medical product.
True or False?

Question 2:
Health care providers are required to report all adverse drug events.
True or False?

Question 3:
The frequency of experiencing adverse drug event X for a given drug can be determined through spontaneous reporting systems.
True or False?

Question 4:
A safety signal could be:
A. A new, previously unknown, adverse event
B. A new drug interaction
C. An observed change in quantity, severity, or in the affected population of a known adverse event
D. All of the above

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