CITI- Training- Questions With All Correct Answers
What are the three principles discussed in the Belmont Report? correct
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. correct 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. correct answer -D.
Information, Comprehension, voluntariness.
Development of most new drugs from discovery to marketing approval
usually takes: correct 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?
correct answer -Phase III
Long-term toxicology of an experimental drug in animals most likely refers to
which part of drug development? correct 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? correct 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? correct answer -
Preclinical data
A primary purpose of the ICH is to correct answer -Minimize the need for
redundant research.
The ICH GCP Guidelines correct answer -Set standards for the design,
conduct, monitoring and reporting of clinical research.
The ICH E6 GCP describes standards that apply to correct answer -
Investigators, sponsors, and IRBs.
In the United States, following the ICH E6 guideline is correct answer -
Voluntary for FDA-regulated drug studies.
The new ICH E6 integrated addendum (R2) requires sponsors to implement
systems to manage quality throughout all stages of the trial process. The
system should use a risk-based approach including which of the following?
correct answer -Identification of study risks to determine which may safely
be omitted from continual monitoring.
What is the legal status of ICH in U.S.? correct answer -It is a FDA guidance
In terms of explaining the probability of assignment to trial arms in consent
forms, which is true? correct answer -ICH notes that it should be included,
but does not specify how the information should be presented.
Regarding subject receipt of a signed and dated copy of the consent forms,
which is true about FDA regulations? correct answer -The FDA regulations
allow subjects or the legally acceptable representatives (LARs) to receive
either a signed or unsigned copy
The new ICH E6 integrated addendum (R2) requires sponsors to implement
systems to manage quality throughout all stages of the trial process. The
What are the three principles discussed in the Belmont Report? correct
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. correct 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. correct answer -D.
Information, Comprehension, voluntariness.
Development of most new drugs from discovery to marketing approval
usually takes: correct 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?
correct answer -Phase III
Long-term toxicology of an experimental drug in animals most likely refers to
which part of drug development? correct 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? correct 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? correct answer -
Preclinical data
A primary purpose of the ICH is to correct answer -Minimize the need for
redundant research.
The ICH GCP Guidelines correct answer -Set standards for the design,
conduct, monitoring and reporting of clinical research.
The ICH E6 GCP describes standards that apply to correct answer -
Investigators, sponsors, and IRBs.
In the United States, following the ICH E6 guideline is correct answer -
Voluntary for FDA-regulated drug studies.
The new ICH E6 integrated addendum (R2) requires sponsors to implement
systems to manage quality throughout all stages of the trial process. The
system should use a risk-based approach including which of the following?
correct answer -Identification of study risks to determine which may safely
be omitted from continual monitoring.
What is the legal status of ICH in U.S.? correct answer -It is a FDA guidance
In terms of explaining the probability of assignment to trial arms in consent
forms, which is true? correct answer -ICH notes that it should be included,
but does not specify how the information should be presented.
Regarding subject receipt of a signed and dated copy of the consent forms,
which is true about FDA regulations? correct answer -The FDA regulations
allow subjects or the legally acceptable representatives (LARs) to receive
either a signed or unsigned copy
The new ICH E6 integrated addendum (R2) requires sponsors to implement
systems to manage quality throughout all stages of the trial process. The
