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ACRP-CP Exam Questions and Answers.
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ACRP-CP Exam Questions and Answers.What is an ADR? - ANS 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? - ANS 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
unfavorable 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? - ANS 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? - ANS 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? - ANS 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, and patients in emergency situations,
ethnic minority groups, homeless persons, nomads, refugees, minors, and those
incapable of giving consent.
GCP: Clinical trials should be conducted in accordance with the ethical principles that
have their origin in the ___________ __ ________, and that are consistent with GCP
and the applicable regulatory requirement(s). - ANS Declaration of Helsinki
GCP: What is beneficence? - ANS The idea that foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the individual trial subject and
society. A trial should be initiated and continued only if the anticipated benefits justify
the risks.
GCP: What are the most important considerations in clinical trials? And should thus
prevail over interests of science and society? - ANS The rights, safety, and well-being of
the trial subjects.
GCP: What qualifies an individual to conduct, or work on, a clinical trial? - ANS
Education, training, and experience to perform his or her task(s).
GCP: What should be obtained from every subject prior to clinical trial participation? -
ANS Freely given informed consent.
What is the purpose of the IRB/IEC? - ANS An IRB/IEC should safeguard the rights,
safety, and well-being of all trial subjects. Special attention should be paid to trials that
may include vulnerable subjects.
How frequently should the IRB/IEC conduct a CR of each ongoing trial? - ANS The
IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate
to the degree of risk to human subjects, but at least once per year.
What is the minimum number of members for an IRB/IEC? And what specific people
need to be involved? - ANS (a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.
What four things should the investigator promptly report to the IRB/IEC? - ANS (a)
Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial
subjects.
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