ACRP CP Exam Verified Exam Questions and Answers Latest update
2026/2027
Question:
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.
Question:
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)
Question:
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)
Question:
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)
, Question:
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.
Question:
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
Question:
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.
Question:
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 wellbeing of the trial subjects.
Question:
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).
2026/2027
Question:
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.
Question:
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)
Question:
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)
Question:
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)
, Question:
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.
Question:
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
Question:
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.
Question:
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 wellbeing of the trial subjects.
Question:
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).
