ACRP-CP Exam Questions with Correct Answers
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Terms in this set (38)
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
What is an ADR? 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.
, 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
What is an AE?
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.
Serious adverse event (SAE)
1. Results in death
2. Is life-threatening
What is an SAE? 3. Requires inpatient hospitalization or prolongation
of existing hospitalization
4. Results in persistent or significant
disability/incapacity
5. Is a congenital anomaly/birth defect
Unexpected adverse drug reaction (UADR)
1. An adverse reaction, the nature or severity of which
What is an UADR? 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)
100% Verified
Save
Terms in this set (38)
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
What is an ADR? 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.
, 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
What is an AE?
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.
Serious adverse event (SAE)
1. Results in death
2. Is life-threatening
What is an SAE? 3. Requires inpatient hospitalization or prolongation
of existing hospitalization
4. Results in persistent or significant
disability/incapacity
5. Is a congenital anomaly/birth defect
Unexpected adverse drug reaction (UADR)
1. An adverse reaction, the nature or severity of which
What is an UADR? 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)
