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 med...
ACRP-CP Exam Questions with 100%
Correct Answers
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)
Who constitutes a vulnerable subject? Correct 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.
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.
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). Correct Answer Declaration of Helsinki
GCP: What is beneficence? Correct Answer 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? Correct Answer The rights, safety, and
well-being of the trial subjects.
GCP: What qualifies an individual to conduct, or work on, a clinical trial? Correct Answer
Education, training, and experience to perform his or her task(s).
GCP: What should be obtained from every subject prior to clinical trial participation?
Correct Answer Freely given informed consent.
What is the purpose of the IRB/IEC? Correct Answer 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? Correct Answer
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? Correct Answer (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.
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