CITI Training Exam Questions and
Answers 100% PASS
What are the three principles discussed in the Belmont Report?—ANSWER-Justice,
Beneficence, and Respect for Persons
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
A primary purpose of the ICH is to—ANSWER-Minimize the need for redundant research.
The ICH GCP Guidelines—ANSWER-Set standards for the design, conduct, monitoring and
reporting of clinical research.
The ICH E6 GCP describes standards that apply to—ANSWER-Investigators, sponsors, and
IRBs.
© 2026 Copyright. All Rights Reserved. This document is
protected by copyright law, Copyrighted By Brittie Donald
Answers 100% PASS
What are the three principles discussed in the Belmont Report?—ANSWER-Justice,
Beneficence, and Respect for Persons
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
A primary purpose of the ICH is to—ANSWER-Minimize the need for redundant research.
The ICH GCP Guidelines—ANSWER-Set standards for the design, conduct, monitoring and
reporting of clinical research.
The ICH E6 GCP describes standards that apply to—ANSWER-Investigators, sponsors, and
IRBs.
© 2026 Copyright. All Rights Reserved. This document is
protected by copyright law, Copyrighted By Brittie Donald
