ACRP-CP Exam Questions with
Correct Answers 100% Verified
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)
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Correct Answers 100% Verified
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)
COPYRIGHT ALL RIGHTS RESERVED ©️ 2025
