ACRP-CP CERTIFICATION ACTUAL EXAM
QUESTIONS WITH DETAILED VERIFIED
SOLUTIONS
◉Who is ultimately responsible for all aspects of the research conducted
at a site? . Answer: Principal investigator
◉Define GCP . Answer: An international quality standard that is
provided by ICH E6(R2) describing safety, accuracy of trials and
credibility of data
◉What event resulted in the Nuremburg Cod of 1949 . Answer: Nazi
Medical Experiments
◉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
QUESTIONS WITH DETAILED VERIFIED
SOLUTIONS
◉Who is ultimately responsible for all aspects of the research conducted
at a site? . Answer: Principal investigator
◉Define GCP . Answer: An international quality standard that is
provided by ICH E6(R2) describing safety, accuracy of trials and
credibility of data
◉What event resulted in the Nuremburg Cod of 1949 . Answer: Nazi
Medical Experiments
◉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
