ACRP-CP Exam ALL CORRECT 2024 EDITION GUARANTEED GRADE A+
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ACRP-CP Exam ALL CORRECT 2024 EDITION GUARANTEED GRADE A+
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 ...
ACRP-CP Exam ALL CORRECT 2024
EDITION GUARANTEED GRADE A+
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.
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
(investigational) product, whether or not related to the medicinal
(investigational) product.
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
What is an UADR?
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?
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).
Declaration of Helsinki
GCP: What is beneficence?
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?
The rights, safety, and well-being of the trial subjects.
GCP: What qualifies an individual to conduct, or work on, a clinical
trial?
Education, training, and experience to perform his or her task(s).
GCP: What should be obtained from every subject prior to clinical
trial participation?
Freely given informed consent.
What is the purpose of the IRB/IEC?
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?
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