Challenge: ICH E2A - Safety First
Question Number 1
According to ICH E2A which of the following is the correct definition of an adverse event?
A
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which may have a causal relationship with this treatment.
B
Any untoward occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
C
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
D
ICH E2A does not have a definition of an Adverse Event

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