ACRP CP SAMPLE QUESTIONS AND ANSWERS |latest updates|
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Course
ACRP CP
Institution
ACRP CP
ACRP CP SAMPLE QUESTIONS AND
ANSWERS |latest updates|
Which ICH Guideline is known as the GCP guideline? - ANSWER E6(R2)
What are the basic ethical principles of the Belmont Report? - ANSWER Beneficence,
Respect for persons, Justice
Define CBER, and full title - ANSWER Cent...
ACRP CP SAMPLE QUESTIONS AND
ANSWERS |latest updates|
Which ICH Guideline is known as the GCP guideline? - ANSWER E6(R2)
What are the basic ethical principles of the Belmont Report? - ANSWER Beneficence,
Respect for persons, Justice
Define CBER, and full title - ANSWER Center for Biologics Evaluation and Research
FDA center that regulates blood, vaccine, gene therapy and tissue
What is the International Conference on Harmonization (ICH) Guidelines? - ANSWER
A unified standard to facilitate the mutual acceptance of clinical data by the regulatory
authorities in the European Union, Japan and United States.
To be a qualifying clinical trial, which three requirements must be met? - ANSWER
Therapeutic Intent
Enrolls patients with diagnosed disease
Evaluates an item/service that falls within a Medicare Benefit Category
Define informed consent - ANSWER A process by which a subject voluntarily confirms
his or her willingness to participate in a particular trial, after having been informed of all
aspects of the trial that are relevant to the subjects decision to participate.
Primary purpose of IRB - ANSWER To ensure the protection of the rights and welfare
of the human subjects
When can IRB waive informed consent? - ANSWER IRB has the ability to waive the
informed consent requirement if the research is no more than minimal risk and involves
no procedures for which consent is required outside of the research context and in
emergency research
An investigational New Drug (IND) Application becomes effective ___ days after receipt
by the FDA (barring a hold, request for additional information, or rejection of an
application); is valid one year; and must be updated within ___ days of taking effect. -
ANSWER 30, 60
Phase II - ANSWER Focuses primarily on safety and effectiveness, is dose-ranging
and occurs in subjects with the disease or condition.
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