1|Page
ACRP-CP EXAM/ACTUAL EXAM(Includes ICH E2A, E6
(R2), E8 (R1), E9, E11 (R1), Declaration of Helsinki)
QUESTIONS AND WELL DETAILED ANSWERS/GRADE
A+ ASSURED/NEWEST UPDATE
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.
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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.
ACRP-CP EXAM/ACTUAL EXAM(Includes ICH E2A, E6
(R2), E8 (R1), E9, E11 (R1), Declaration of Helsinki)
QUESTIONS AND WELL DETAILED ANSWERS/GRADE
A+ ASSURED/NEWEST UPDATE
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.
, 2|Page
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.
