CITI Training - Research Method Questions With All
Correct Answers
What is the term for management controls that are built in to a research study
(for example, independent data analysis)? correct answer -Inherent
controls
The FDA regulations governing disclosure of individual COIs require:
correct answer -Applicants submitting marketing applications to disclose
nancial COIs of researchers who conducted clinical studies
The PHS regulations about nancial con ict of interests require which party to
disclose signi cant nancial con icts of interest? correct answer -Researcher
An example of an individual nancial COI is: correct answer -A researcher's
wife holds equity in a publicly traded pharmaceutical company that is also the
sponsor of the
researcher's study.
During an Institutional Review Board (IRB) meeting, any IRB member who
may have a potential COI with a study under review should: correct answer
-Disclose their potential COI and may answer questions, but recuse
themselves from voting
The peer review process can create con icts of interest because the choice of
who reviews a potentially publishable project may
show: correct answer -There may be bias by the peer reviewer as to the
area of research
A researcher calls you stating that he plans to submit a proposal to the NIH for
a human subjects research study. He
wants to know at what point he and his study team must submit COI
disclosures to comply with the PHS regulation. correct answer -No later
than the time of proposal submission
A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because: correct answer -It may be
Correct Answers
What is the term for management controls that are built in to a research study
(for example, independent data analysis)? correct answer -Inherent
controls
The FDA regulations governing disclosure of individual COIs require:
correct answer -Applicants submitting marketing applications to disclose
nancial COIs of researchers who conducted clinical studies
The PHS regulations about nancial con ict of interests require which party to
disclose signi cant nancial con icts of interest? correct answer -Researcher
An example of an individual nancial COI is: correct answer -A researcher's
wife holds equity in a publicly traded pharmaceutical company that is also the
sponsor of the
researcher's study.
During an Institutional Review Board (IRB) meeting, any IRB member who
may have a potential COI with a study under review should: correct answer
-Disclose their potential COI and may answer questions, but recuse
themselves from voting
The peer review process can create con icts of interest because the choice of
who reviews a potentially publishable project may
show: correct answer -There may be bias by the peer reviewer as to the
area of research
A researcher calls you stating that he plans to submit a proposal to the NIH for
a human subjects research study. He
wants to know at what point he and his study team must submit COI
disclosures to comply with the PHS regulation. correct answer -No later
than the time of proposal submission
A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because: correct answer -It may be
