CITI TRAINING UPDATED ACTUAL EXAM
QUESTIONS AND CORRECT ANSWERS
COMPLETE STUDY RESOURCE
◉ Which of the following is an example of how the Principle of
Beneficence can be applied to a study employing human subjects?
A. Providing detailed information about the study and obtaining
the subject's consent to participate.
B. Insuring that the selection of subjects includes people from all
segments of the population.
C. Determining that the study has maximized benefits and
minimized risks.
D. Ensuring that confidentiality is maintained.
Answer: C. Determining that the study has a maximization of
benefits and a minimization of risks.
◉ Which of the following best describes the principle of informed
consent as described in the Belmont Report?
A. Voluntariness, risk/benefit assessment, selection of subjects.
B. Comprehension, conflicts of interest, risk/benefit ratio.
C. Risk/benefit assessment, justification of research,
comprehension.
D. Information, comprehension, voluntariness.
, Answer: D. Information, Comprehension, voluntariness.
◉ Development of most new drugs from discovery to marketing
approval usually takes:
Answer: 9 years or more
◉ Adults with more than a 12-month history of migraines were
assigned randomly in a double-blinded study to receive treatment
with experimental drug X (10 or 20 mg/day) or placebo. The
primary efficacy measure was the reduction in severity of the
migraine attacks. Enrollment was 1200 subjects. Which of the
following best describes the clinical phase of this study?
Answer: Phase III
◉ Long-term toxicology of an experimental drug in animals most
likely refers to which part of drug development?
Answer: Preclinical
◉ Pharmacokinetics and pharmacodynamics of a new
formulation of an investigational drug most likely refers to which
clinical phase of a study in humans?
Answer: Phase I
◉ For a phase I new drug study in humans, what is the primary
source of the data included in the initial Investigator's Brochure?
Answer: Preclinical data
QUESTIONS AND CORRECT ANSWERS
COMPLETE STUDY RESOURCE
◉ Which of the following is an example of how the Principle of
Beneficence can be applied to a study employing human subjects?
A. Providing detailed information about the study and obtaining
the subject's consent to participate.
B. Insuring that the selection of subjects includes people from all
segments of the population.
C. Determining that the study has maximized benefits and
minimized risks.
D. Ensuring that confidentiality is maintained.
Answer: C. Determining that the study has a maximization of
benefits and a minimization of risks.
◉ Which of the following best describes the principle of informed
consent as described in the Belmont Report?
A. Voluntariness, risk/benefit assessment, selection of subjects.
B. Comprehension, conflicts of interest, risk/benefit ratio.
C. Risk/benefit assessment, justification of research,
comprehension.
D. Information, comprehension, voluntariness.
, Answer: D. Information, Comprehension, voluntariness.
◉ Development of most new drugs from discovery to marketing
approval usually takes:
Answer: 9 years or more
◉ Adults with more than a 12-month history of migraines were
assigned randomly in a double-blinded study to receive treatment
with experimental drug X (10 or 20 mg/day) or placebo. The
primary efficacy measure was the reduction in severity of the
migraine attacks. Enrollment was 1200 subjects. Which of the
following best describes the clinical phase of this study?
Answer: Phase III
◉ Long-term toxicology of an experimental drug in animals most
likely refers to which part of drug development?
Answer: Preclinical
◉ Pharmacokinetics and pharmacodynamics of a new
formulation of an investigational drug most likely refers to which
clinical phase of a study in humans?
Answer: Phase I
◉ For a phase I new drug study in humans, what is the primary
source of the data included in the initial Investigator's Brochure?
Answer: Preclinical data
