ACRP-CP Exam Questions with 100%
Correct Answers
What is an ADR? Correct 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? Correct 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? Correct 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? Correct Answer: 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 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.
Correct Answers
What is an ADR? Correct 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? Correct 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? Correct 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? Correct Answer: 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 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.
