ACRP CP Exam ACTUAL Questions and
CORRECT Answers
What is an ADR? - CORRECT ANSWERS 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? - CORRECT ANSWERS 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? - CORRECT ANSWERS 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? - CORRECT ANSWERS 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? - CORRECT ANSWERS 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). - CORRECT ANSWERS Declaration of Helsinki
GCP: What is beneficence? - CORRECT ANSWERS 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? - CORRECT ANSWERS The rights, safety, and well-
being of the trial subjects.
GCP: What qualifies an individual to conduct, or work on, a clinical trial? - CORRECT
ANSWERS Education, training, and experience to perform his or her task(s).
CORRECT Answers
What is an ADR? - CORRECT ANSWERS 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? - CORRECT ANSWERS 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? - CORRECT ANSWERS 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? - CORRECT ANSWERS 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? - CORRECT ANSWERS 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). - CORRECT ANSWERS Declaration of Helsinki
GCP: What is beneficence? - CORRECT ANSWERS 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? - CORRECT ANSWERS The rights, safety, and well-
being of the trial subjects.
GCP: What qualifies an individual to conduct, or work on, a clinical trial? - CORRECT
ANSWERS Education, training, and experience to perform his or her task(s).
