1
ACRP-CP Exam Questions and Answers
(100% Correct Answers) Already Graded
A+
What is an ADR? Ans: Adverse drug reaction (ADR)
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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
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product means that a causal relationship between a 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.
What is an AE? Ans: 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
treatment. An adverse event (AE) can therefore be any
unfavourable and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally associated
, 2
with the use of a medicinal (investigational) product, whether or
not related to the medicinal (investigational) product.
What is an SAE? Ans: Serious adverse event (SAE)
1. Results in death
2. Is life-threatening
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3. Requires inpatient hospitalization or prolongation of existing
hospitalization
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4. Results in persistent or significant disability/incapacity
5. Is a congenital anomaly/birth defect
What is an UADR? Ans: Unexpected adverse drug reaction
(UADR)
1. An adverse reaction, the nature or severity of which is not
consistent with the applicable product information (e.g., IB for an
unapproved IP or package insert/summary of product
characteristics for an approved product)
Who constitutes a vulnerable subject? Ans: Individuals whose
willingness to volunteer in a clinical trial may be unduly influenced
by the expectation of benefits associated with participation, or of
ACRP-CP Exam Questions and Answers
(100% Correct Answers) Already Graded
A+
What is an ADR? Ans: Adverse drug reaction (ADR)
© 2025 Assignment Expert
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
Guru01 - Stuvia
product means that a causal relationship between a 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.
What is an AE? Ans: 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
treatment. An adverse event (AE) can therefore be any
unfavourable and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally associated
, 2
with the use of a medicinal (investigational) product, whether or
not related to the medicinal (investigational) product.
What is an SAE? Ans: Serious adverse event (SAE)
1. Results in death
2. Is life-threatening
© 2025 Assignment Expert
3. Requires inpatient hospitalization or prolongation of existing
hospitalization
Guru01 - Stuvia
4. Results in persistent or significant disability/incapacity
5. Is a congenital anomaly/birth defect
What is an UADR? Ans: Unexpected adverse drug reaction
(UADR)
1. An adverse reaction, the nature or severity of which is not
consistent with the applicable product information (e.g., IB for an
unapproved IP or package insert/summary of product
characteristics for an approved product)
Who constitutes a vulnerable subject? Ans: Individuals whose
willingness to volunteer in a clinical trial may be unduly influenced
by the expectation of benefits associated with participation, or of
