CITI Training Exam Questions and
Answers13
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? - ANSWERS-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.
The most appropriate action for the investigator to take is to report the adverse drug experience
in a timely manner using the forms provided by the institution.
How long is an investigator required to keep consent documents, IRB correspondence, and
research records? - ANSWERS-For a minimum of three years after completion of the study
Research investigators are responsible for retaining signed consent documents, IRB
correspondence, and research records for at least three years after completion of the research.
Because research records are the property of the institution, local institutional policy or
sponsoring agency requirements may dictate these records are kept longer. The sponsor and the
IRB office should be contacted to make sure that the minimum of three years meets their
requirements.
According to federal regulations, which of the following best describes when expedited review
of a new, proposed study may be used by the IRB? - ANSWERS-The study involves no more than
minimal risk and meets one of the allowable categories of expedited review specified in federal
regulations
The study involves no more than minimal risk and meets one of the allowable categories of
expedited review specified in federal regulations. Expedited review procedures are appropriate
only for protocols that present no greater than "minimal risk" to subjects and involve only
, procedures included in federally specified categories. Population considerations, such as healthy
volunteers, are only relevant insofar as they affect the assessment of risk. The IRB may not
conduct an expedited review for the convenience of either the IRB or a student researcher, if
the protocol is otherwise not eligible.
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: -
ANSWERS-The changes must be immediately implemented for the health and well-being of the
subject.
All amendments involving changes to IRB-approved protocols must be reviewed and approved
in advance of implementation, unless changes must be put in place immediately to respond to
an unexpected risk or problem arising during the course of a study.
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must: - ANSWERS-Occur at least annually.
Approved greater than minimal risk protocols must be reviewed at least annually, although IRBs
may specify a shorter review period. It is the responsibility of the principal investigator to hold
signed consent forms in confidentiality. Copies of these forms are not required by federal
regulation to be reviewed by the IRB. Please note, however, that an institution's local policy may
require copies of signed consent forms as part of the IRB continuing review process.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - ANSWERS-A study of twenty 4th grade classrooms in which
researchers ask the schools to systematically vary the time of day reading is taught, and collect
weekly assessments of reading comprehension for each child over a three-month period.
The study in the 4th grade classrooms about the relationship between the time of day reading is
taught and reading comprehension does meet the definition of research with human subjects.
The study is designed to contribute to generalizable knowledge about student performance and
the research question can only be answered using a systematic investigation.
Answers13
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? - ANSWERS-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.
The most appropriate action for the investigator to take is to report the adverse drug experience
in a timely manner using the forms provided by the institution.
How long is an investigator required to keep consent documents, IRB correspondence, and
research records? - ANSWERS-For a minimum of three years after completion of the study
Research investigators are responsible for retaining signed consent documents, IRB
correspondence, and research records for at least three years after completion of the research.
Because research records are the property of the institution, local institutional policy or
sponsoring agency requirements may dictate these records are kept longer. The sponsor and the
IRB office should be contacted to make sure that the minimum of three years meets their
requirements.
According to federal regulations, which of the following best describes when expedited review
of a new, proposed study may be used by the IRB? - ANSWERS-The study involves no more than
minimal risk and meets one of the allowable categories of expedited review specified in federal
regulations
The study involves no more than minimal risk and meets one of the allowable categories of
expedited review specified in federal regulations. Expedited review procedures are appropriate
only for protocols that present no greater than "minimal risk" to subjects and involve only
, procedures included in federally specified categories. Population considerations, such as healthy
volunteers, are only relevant insofar as they affect the assessment of risk. The IRB may not
conduct an expedited review for the convenience of either the IRB or a student researcher, if
the protocol is otherwise not eligible.
Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: -
ANSWERS-The changes must be immediately implemented for the health and well-being of the
subject.
All amendments involving changes to IRB-approved protocols must be reviewed and approved
in advance of implementation, unless changes must be put in place immediately to respond to
an unexpected risk or problem arising during the course of a study.
IRB continuing review of a greater than minimal risk approved protocol that is currently
enrolling subjects must: - ANSWERS-Occur at least annually.
Approved greater than minimal risk protocols must be reviewed at least annually, although IRBs
may specify a shorter review period. It is the responsibility of the principal investigator to hold
signed consent forms in confidentiality. Copies of these forms are not required by federal
regulation to be reviewed by the IRB. Please note, however, that an institution's local policy may
require copies of signed consent forms as part of the IRB continuing review process.
According to the federal regulations, which of the following studies meets the definition of
research with human subjects? - ANSWERS-A study of twenty 4th grade classrooms in which
researchers ask the schools to systematically vary the time of day reading is taught, and collect
weekly assessments of reading comprehension for each child over a three-month period.
The study in the 4th grade classrooms about the relationship between the time of day reading is
taught and reading comprehension does meet the definition of research with human subjects.
The study is designed to contribute to generalizable knowledge about student performance and
the research question can only be answered using a systematic investigation.
