ACRP CP Exam Review Questions with
Verified Correct Answers
What is an ADR?
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?
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?
, 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?
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?
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,
Verified Correct Answers
What is an ADR?
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?
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?
, 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?
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?
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,
