CITI EXAMS 2025 QUESTIONS AND
ANSWERS
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.
...©️ 2025, ALL RIGHTS RESERVED 1
, According to the federal regulations, which of the following studies meets the definition
of research with human subjects? - ....ANSWER ...-A developmental psychologist
videotapes interactions between groups of toddlers and their caregivers to determine
which intervention methods most effectively manage aggression.
According to the federal regulations, which of the following studies meets the definition
of research with human subjects? - ....ANSWER ...-A cognitive psychologist enrolls
undergraduate students for a computer-based study about the effect of mood on
problem-solving behaviors.
According to the federal regulations, which of the following studies meets the definition
of research with human subjects? - ....ANSWER ...-An experiment is proposed on
the relationship between gender-related stereotypes in math and the subsequent
performance by males and females on math tests.
A researcher is interested in assessing risk-taking by individuals. The researcher is
sitting on a bench near a busy four-way stop intersection. She plans on recording the
number of bike riders wearing a safety helmet and whether they stop at the intersection
before proceeding in order to correlate use of safety apparel with risk-taking. This
collection of information is an example of: - ....ANSWER ...-public behavior
According to the federal regulations, human subjects are living individuals about whom
an investigator conducting research obtains information through interaction or
intervention with the individual, and uses, studies, or analyzes the information; or: -
....ANSWER ...-Obtains, uses, studies, analyzes, or generates identifiable private
information.
...©️ 2025, ALL RIGHTS RESERVED 2
ANSWERS
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.
...©️ 2025, ALL RIGHTS RESERVED 1
, According to the federal regulations, which of the following studies meets the definition
of research with human subjects? - ....ANSWER ...-A developmental psychologist
videotapes interactions between groups of toddlers and their caregivers to determine
which intervention methods most effectively manage aggression.
According to the federal regulations, which of the following studies meets the definition
of research with human subjects? - ....ANSWER ...-A cognitive psychologist enrolls
undergraduate students for a computer-based study about the effect of mood on
problem-solving behaviors.
According to the federal regulations, which of the following studies meets the definition
of research with human subjects? - ....ANSWER ...-An experiment is proposed on
the relationship between gender-related stereotypes in math and the subsequent
performance by males and females on math tests.
A researcher is interested in assessing risk-taking by individuals. The researcher is
sitting on a bench near a busy four-way stop intersection. She plans on recording the
number of bike riders wearing a safety helmet and whether they stop at the intersection
before proceeding in order to correlate use of safety apparel with risk-taking. This
collection of information is an example of: - ....ANSWER ...-public behavior
According to the federal regulations, human subjects are living individuals about whom
an investigator conducting research obtains information through interaction or
intervention with the individual, and uses, studies, or analyzes the information; or: -
....ANSWER ...-Obtains, uses, studies, analyzes, or generates identifiable private
information.
...©️ 2025, ALL RIGHTS RESERVED 2
