ACRP-CP EXAM QUESTIONS AND
ANSWERS GRADED A+ 2025/2026
What is an ADR? - ANS 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 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 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)
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, 1. Results in death
2. Is life-threatening
3. Requires inpatient hospitalization or prolongation of existing hospitalization
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 a retaliatory response from senior members of a hierarchy in case of refusal
to participate.
Examples are members of a group with a hierarchical structure, such as medical, pharmacy,
dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
pharmaceutical industry, members of the armed forces, and persons kept in detention.
Other vulnerable subjects include patients with incurable diseases, persons in nursing homes,
unemployed or impoverished persons, patients in emergency situations, ethnic minority groups,
homeless persons, nomads, refugees, minors, and those incapable of giving consent.
GCP: Clinical trials should be conducted in accordance with the ethical principles that have their
origin in the ___________ __ ________, and that are consistent with GCP and the applicable
regulatory requirement(s). - ANS Declaration of Helsinki
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ANSWERS GRADED A+ 2025/2026
What is an ADR? - ANS 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 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 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 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
, 1. Results in death
2. Is life-threatening
3. Requires inpatient hospitalization or prolongation of existing hospitalization
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 a retaliatory response from senior members of a hierarchy in case of refusal
to participate.
Examples are members of a group with a hierarchical structure, such as medical, pharmacy,
dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
pharmaceutical industry, members of the armed forces, and persons kept in detention.
Other vulnerable subjects include patients with incurable diseases, persons in nursing homes,
unemployed or impoverished persons, patients in emergency situations, ethnic minority groups,
homeless persons, nomads, refugees, minors, and those incapable of giving consent.
GCP: Clinical trials should be conducted in accordance with the ethical principles that have their
origin in the ___________ __ ________, and that are consistent with GCP and the applicable
regulatory requirement(s). - ANS Declaration of Helsinki
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
