, 11/24/24, 7:14 AM ACRP CP EXAM 2024 NEWEST ACTUAL EXAM COMPLETE 100 QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% …
Adverse drug reaction (ADR)
1.Pre-approval clinical experience with a new
medicinal product or its new usages: all noxious and
unintended responses to a medicinal product related
to any dose should be considered adverse drug
reactions. The phrase responses to a medicinal
product means that a causal relationship between a
What is an ADR? medicinal product and an adverse event is at least a
reasonable possibility, i.e., the relationship cannot be
ruled out.
2. Regarding marketed medicinal products: a
response to a drug which is noxious and unintended
and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function.
Adverse event (AE)
1. 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
What is an AE?
treatment. An adverse event (AE) can therefore be
any unfavourable and unintended sign (including an
abnormal laboratory finding), symptom, or disease
temporally associated with the use of a medicinal
(investigational) product, whether or not related to
the medicinal (investigational) product.
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