CITI Training Exam with Verified Solutions
1. What are the three principles discussed in the Bel- Justice, Benefi-
mont Report? cence, and Re-
spect for Persons
2. Which of the following is an example of how the C. Determining
Principle of Beneficence can be applied to a study that the study
employing human subjects? has a maximiza-
A. Providing detailed information about the study and tion of benefits and
obtaining the subject's consent to participate. a minimization of
B. Insuring that the selection of subjects includes risks.
people from all segments of the population.
C. Determining that the study has maximized benefits
and minimized risks.
D. Ensuring that confidentiality is maintained.
3. Which of the following best describes the principle D. Informa-
of informed consent as described in the Belmont Re- tion, Comprehen-
port? sion, voluntari-
A. Voluntariness, risk/benefit assessment, selection of ness.
subjects.
B. Comprehension, conflicts of interest, risk/benefit
ratio.
C. Risk/benefit assessment, justification of research,
comprehension.
D. Information, comprehension, voluntariness.
4. Development of most new drugs from discovery to 9 years or more
marketing approval usually takes:
5. Adults with more than a 12-month history of mi- Phase III
graines 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?
6. Preclinical
1/8
, CITI Training Exam with Verified Solutions
Long-term toxicology of an experimental drug in ani-
mals most likely refers to which part of drug develop-
ment?
7. Pharmacokinetics and pharmacodynamics of a new Phase I
formulation of an investigational drug most likely
refers to which clinical phase of a study in humans?
8. For a phase I new drug study in humans, what is Preclinical data
the primary source of the data included in the initial
Investigator's Brochure?
9. A primary purpose of the ICH is to Minimize the need
for redundant re-
search.
10. The ICH GCP Guidelines Set standards for
the design, con-
duct, monitoring
and reporting of
clinical research.
11. The ICH E6 GCP describes standards that apply to Investigators,
sponsors, and
IRBs.
12. In the United States, following the ICH E6 guideline is Voluntary for
FDA-regulated
drug studies.
13. The new ICH E6 integrated addendum (R2) requires Identification of
sponsors to implement systems to manage quality study risks to de-
throughout all stages of the trial process. The system termine which may
should use a risk-based approach including which of safely be omit-
the following? ted from continual
monitoring.
14. What is the legal status of ICH in U.S.? It is a FDA guid-
ance
2/8
1. What are the three principles discussed in the Bel- Justice, Benefi-
mont Report? cence, and Re-
spect for Persons
2. Which of the following is an example of how the C. Determining
Principle of Beneficence can be applied to a study that the study
employing human subjects? has a maximiza-
A. Providing detailed information about the study and tion of benefits and
obtaining the subject's consent to participate. a minimization of
B. Insuring that the selection of subjects includes risks.
people from all segments of the population.
C. Determining that the study has maximized benefits
and minimized risks.
D. Ensuring that confidentiality is maintained.
3. Which of the following best describes the principle D. Informa-
of informed consent as described in the Belmont Re- tion, Comprehen-
port? sion, voluntari-
A. Voluntariness, risk/benefit assessment, selection of ness.
subjects.
B. Comprehension, conflicts of interest, risk/benefit
ratio.
C. Risk/benefit assessment, justification of research,
comprehension.
D. Information, comprehension, voluntariness.
4. Development of most new drugs from discovery to 9 years or more
marketing approval usually takes:
5. Adults with more than a 12-month history of mi- Phase III
graines 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?
6. Preclinical
1/8
, CITI Training Exam with Verified Solutions
Long-term toxicology of an experimental drug in ani-
mals most likely refers to which part of drug develop-
ment?
7. Pharmacokinetics and pharmacodynamics of a new Phase I
formulation of an investigational drug most likely
refers to which clinical phase of a study in humans?
8. For a phase I new drug study in humans, what is Preclinical data
the primary source of the data included in the initial
Investigator's Brochure?
9. A primary purpose of the ICH is to Minimize the need
for redundant re-
search.
10. The ICH GCP Guidelines Set standards for
the design, con-
duct, monitoring
and reporting of
clinical research.
11. The ICH E6 GCP describes standards that apply to Investigators,
sponsors, and
IRBs.
12. In the United States, following the ICH E6 guideline is Voluntary for
FDA-regulated
drug studies.
13. The new ICH E6 integrated addendum (R2) requires Identification of
sponsors to implement systems to manage quality study risks to de-
throughout all stages of the trial process. The system termine which may
should use a risk-based approach including which of safely be omit-
the following? ted from continual
monitoring.
14. What is the legal status of ICH in U.S.? It is a FDA guid-
ance
2/8
