ACRP-CP Exam Questions and Answers
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)
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.
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)
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.
