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ACRP CCRC EXAM PREP WITH COMPLETE SOLUTIONS
Question: What Is An Adverse Drug Reaction (ADR)?
Correct Answer: All Noxious And Unintended
Responses To A Medicinal Product Related To Any Dose
Question: What Is An Adverse Event (AE)?
Correct Answer: Any Untoward Medical Occurrence In
A Patient Or Clinical Investigation Subject Administered
A Pharmaceutical Product And Which Does Not
Necessarily Have A Causal Relationship With This
Treatment--Any Unfavorable And Unintended Sign,
Symptom, Or Disease Temporally Associated With The
Use Of A Medicinal Product, Whether Or Not Related To
The Medicinal Product
Question: What Are Applicable Regulatory
Requirements?
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