CITI TRAINING EXAM PREP QUESTIONS
AND ANSWERS FULL TEST PAPER
ACCURACY CHECKED
◉ Which of the following is a risk associated with a small cell
size?
Answer: The risk of disclosure of students' information reported
in that cell
◉ A researcher is conducting a study of four graduate students
enrolled in a unique university program. The foundation
supporting the study wants a report that provides summary
information about the students' outcomes, including their grades
and survey responses. What would be the least risky option?
Answer: Provide a summation of survey results, without the
grades
◉ The use of prisoners in research is a concern under the
Belmont principle of Justice because:
Answer: Prisoners may not be used to conduct research that only
benefits the larger society
◉ Issued in 1974, 45 CFR 46 raised to regulatory status
Answer: US Public Health Service Policy
,◉ Informed consent is considered an application of which
Belmont principle?
Answer: Respect for Persons
◉ Which of the following is included in the Nuremberg Code:
Answer: Voluntary consent
◉ Which of the following brought increased public attention to
the problems with the IRB system?
Answer: Death of Research Subject (Jesse Gelsinger)
◉ A subject in a clinical research trial experiences a serious,
unanticipated adverse drug experience. How should the
investigator proceed, with respect to the IRB, after the discovery
of the adverse event occurrence?
Answer: Report the adverse drug experience in a timely manner,
in keeping with the IRB's policies and procedures, using the forms
or the mechanism provided by the IRB.
◉ How long is an investigator required to keep consent
documents, IRB correspondence, and research records?
Answer: For a minimum of three years after completion of the
study
, ◉ According to federal regulations, which of the following best
describes when expedited review of a new, proposed study may
be used by the IRB?
Answer: The study involves no more than minimal risk and meets
one of the allowable categories of expedited review specified in
federal regulations
◉ Amendments involving changes to IRB-approved protocols do
NOT need prior IRB approval if:
Answer: The changes must be immediately implemented for the
health and well-being of the subject.
◉ IRB continuing review of a greater than minimal risk approved
protocol that is currently enrolling subjects must:
Answer: Occur at least annually.
◉ A 46-year-old man is currently enrolled in a Phase 2 study of a
drug for severe diabetic neuropathy. While the study is on-going, a
new drug becomes commercially available that may have equal or
greater benefit to the subject. The investigator should do which of
the following?
Answer: Give the subject comprehensive information about the
new drug, including its side effects. Discuss the pros and cons of
both the investigational drug and the commercially available drug
and then allow the subject to decide whether to withdraw from
the research to take the new drug.
AND ANSWERS FULL TEST PAPER
ACCURACY CHECKED
◉ Which of the following is a risk associated with a small cell
size?
Answer: The risk of disclosure of students' information reported
in that cell
◉ A researcher is conducting a study of four graduate students
enrolled in a unique university program. The foundation
supporting the study wants a report that provides summary
information about the students' outcomes, including their grades
and survey responses. What would be the least risky option?
Answer: Provide a summation of survey results, without the
grades
◉ The use of prisoners in research is a concern under the
Belmont principle of Justice because:
Answer: Prisoners may not be used to conduct research that only
benefits the larger society
◉ Issued in 1974, 45 CFR 46 raised to regulatory status
Answer: US Public Health Service Policy
,◉ Informed consent is considered an application of which
Belmont principle?
Answer: Respect for Persons
◉ Which of the following is included in the Nuremberg Code:
Answer: Voluntary consent
◉ Which of the following brought increased public attention to
the problems with the IRB system?
Answer: Death of Research Subject (Jesse Gelsinger)
◉ A subject in a clinical research trial experiences a serious,
unanticipated adverse drug experience. How should the
investigator proceed, with respect to the IRB, after the discovery
of the adverse event occurrence?
Answer: Report the adverse drug experience in a timely manner,
in keeping with the IRB's policies and procedures, using the forms
or the mechanism provided by the IRB.
◉ How long is an investigator required to keep consent
documents, IRB correspondence, and research records?
Answer: For a minimum of three years after completion of the
study
, ◉ According to federal regulations, which of the following best
describes when expedited review of a new, proposed study may
be used by the IRB?
Answer: The study involves no more than minimal risk and meets
one of the allowable categories of expedited review specified in
federal regulations
◉ Amendments involving changes to IRB-approved protocols do
NOT need prior IRB approval if:
Answer: The changes must be immediately implemented for the
health and well-being of the subject.
◉ IRB continuing review of a greater than minimal risk approved
protocol that is currently enrolling subjects must:
Answer: Occur at least annually.
◉ A 46-year-old man is currently enrolled in a Phase 2 study of a
drug for severe diabetic neuropathy. While the study is on-going, a
new drug becomes commercially available that may have equal or
greater benefit to the subject. The investigator should do which of
the following?
Answer: Give the subject comprehensive information about the
new drug, including its side effects. Discuss the pros and cons of
both the investigational drug and the commercially available drug
and then allow the subject to decide whether to withdraw from
the research to take the new drug.
