ACRP-CP Exam
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1. 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.
2. 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 (investiga-
tional) product, whether or not related to the medicinal (investigational) product.
3. 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
4. What is an UADR? Unexpected adverse drug reaction (UADR)
1. An adverse reaction, the nature or severity of which is not consistent with
, ACRP-CP Exam
Study online at https://quizlet.com/_bdxcc6
the applicable product information (e.g., IB for an unapproved IP or package
insert/summary of product characteristics for an approved product)
5. Who constitutes Individuals whose willingness to volunteer in a clinical trial may be unduly in-
a vulnerable sub- fluenced by the expectation of benefits associated with participation, or of a
ject? 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 per-
sonnel, 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.
6. GCP: Clinical tri- Declaration of Helsinki
als should be
conducted in ac-
cordance with
the ethical prin-
ciples that have
their origin in
the ___________
__ ________, and
that are consis-
tent with GCP
and the applica-
ble regulatory re-
quirement(s).
Study online at https://quizlet.com/_bdxcc6
1. 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.
2. 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 (investiga-
tional) product, whether or not related to the medicinal (investigational) product.
3. 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
4. What is an UADR? Unexpected adverse drug reaction (UADR)
1. An adverse reaction, the nature or severity of which is not consistent with
, ACRP-CP Exam
Study online at https://quizlet.com/_bdxcc6
the applicable product information (e.g., IB for an unapproved IP or package
insert/summary of product characteristics for an approved product)
5. Who constitutes Individuals whose willingness to volunteer in a clinical trial may be unduly in-
a vulnerable sub- fluenced by the expectation of benefits associated with participation, or of a
ject? 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 per-
sonnel, 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.
6. GCP: Clinical tri- Declaration of Helsinki
als should be
conducted in ac-
cordance with
the ethical prin-
ciples that have
their origin in
the ___________
__ ________, and
that are consis-
tent with GCP
and the applica-
ble regulatory re-
quirement(s).
