ACRP CP FINAL EXAM QUESTIONS AND ANSWERS 2025
What is an ADR? - (ANSWER)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? - (ANSWER)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? - (ANSWER)Serious adverse event (SAE)
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? - (ANSWER)Unexpected adverse drug reaction (UADR)
, ACRP CP FINAL EXAM QUESTIONS AND ANSWERS 2025
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? - (ANSWER)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). - (ANSWER)Declaration of Helsinki
GCP: What is beneficence? - (ANSWER)The idea that foreseeable risks and inconveniences should be
weighed against the anticipated benefit for the individual trial subject and society. A trial should be
initiated and continued only if the anticipated benefits justify the risks.
GCP: What are the most important considerations in clinical trials? And should thus prevail over
interests of science and society? - (ANSWER)The rights, safety, and well-being of the trial subjects.
GCP: What qualifies an individual to conduct, or work on, a clinical trial? - (ANSWER)Education, training,
and experience to perform his or her task(s).
GCP: What should be obtained from every subject prior to clinical trial participation? - (ANSWER)Freely
given informed consent.
What is an ADR? - (ANSWER)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? - (ANSWER)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? - (ANSWER)Serious adverse event (SAE)
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? - (ANSWER)Unexpected adverse drug reaction (UADR)
, ACRP CP FINAL EXAM QUESTIONS AND ANSWERS 2025
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? - (ANSWER)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). - (ANSWER)Declaration of Helsinki
GCP: What is beneficence? - (ANSWER)The idea that foreseeable risks and inconveniences should be
weighed against the anticipated benefit for the individual trial subject and society. A trial should be
initiated and continued only if the anticipated benefits justify the risks.
GCP: What are the most important considerations in clinical trials? And should thus prevail over
interests of science and society? - (ANSWER)The rights, safety, and well-being of the trial subjects.
GCP: What qualifies an individual to conduct, or work on, a clinical trial? - (ANSWER)Education, training,
and experience to perform his or her task(s).
GCP: What should be obtained from every subject prior to clinical trial participation? - (ANSWER)Freely
given informed consent.
