CITI exam 2 UPDATED ACTUAL Exam
Questions and CORRECT 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? - CORRECT 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? - CORRECT 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? - CORRECT 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:
- CORRECT ANSWER - The changes must be immediately implemented for the health
and well being of the subject.
IRB continuing review of an approved protocol must: - CORRECT ANSWER - Occur at
least annually.
Questions and CORRECT 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? - CORRECT 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? - CORRECT 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? - CORRECT 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:
- CORRECT ANSWER - The changes must be immediately implemented for the health
and well being of the subject.
IRB continuing review of an approved protocol must: - CORRECT ANSWER - Occur at
least annually.
