Citi- Training- Questions With All 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.
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? correct answer -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? correct
answer -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: correct answer -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: correct answer -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? correct answer -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.
Information collected by the playground designer does not involve any
information about human subjects even though it does involve interaction
between the designer and school staff. An analysis of aggregate data doesn't
involve interactions with living individuals nor the collection of private
identifiable data. An economic feasibility study will gather information from
people with relevant information and expertise but does not meet the
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.
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? correct answer -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? correct
answer -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: correct answer -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: correct answer -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? correct answer -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.
Information collected by the playground designer does not involve any
information about human subjects even though it does involve interaction
between the designer and school staff. An analysis of aggregate data doesn't
involve interactions with living individuals nor the collection of private
identifiable data. An economic feasibility study will gather information from
people with relevant information and expertise but does not meet the
