CITI EXAM2 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 an approved protocol must: - ....ANSWER ...-Occur at
least annually.
...©️ 2025, ALL RIGHTS RESERVED 1
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 an approved protocol must: - ....ANSWER ...-Occur at
least annually.
...©️ 2025, ALL RIGHTS RESERVED 1
