Citi training-PHO 308 module 6 Questions With All
Correct Answers
The PHS regulations about financial conflict of interests require which party
to disclose significant financial conflicts of interest? correct answer -
Researcher
The PHS regulations about financial conflict of interests require the
researcher to disclose significant financial conflicts of interest to the
organization. The FDA's regulation governing disclosure of individual COI
requires applicants submitting marketing applications for drugs, biologics, or
devices to certify the absence of certain financial interests or disclose financial
interests of researchers who conducted clinical studies covered by the
regulation.
An example of an individual financial COI is: correct answer -A
researcher's spouse holds equity in a publicly traded pharmaceutical company
that is also the sponsor of the researcher's study.
An individual COI may arise when an individual has a personal or financial
interest, which may affect or appear to affect the design, conduct, or reporting
of the research.
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
IRB policies and procedures generally specify that members with conflicts of
interest related to an agenda item must disclose their conflicts of interest, and
may answer questions from the IRB about the item with which they have a
conflict, but are prohibited from voting on that item.
What is the term for management controls that are built in to a research study
(for example, independent data analysis)? correct answer -Inherent
controls
Correct Answers
The PHS regulations about financial conflict of interests require which party
to disclose significant financial conflicts of interest? correct answer -
Researcher
The PHS regulations about financial conflict of interests require the
researcher to disclose significant financial conflicts of interest to the
organization. The FDA's regulation governing disclosure of individual COI
requires applicants submitting marketing applications for drugs, biologics, or
devices to certify the absence of certain financial interests or disclose financial
interests of researchers who conducted clinical studies covered by the
regulation.
An example of an individual financial COI is: correct answer -A
researcher's spouse holds equity in a publicly traded pharmaceutical company
that is also the sponsor of the researcher's study.
An individual COI may arise when an individual has a personal or financial
interest, which may affect or appear to affect the design, conduct, or reporting
of the research.
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
IRB policies and procedures generally specify that members with conflicts of
interest related to an agenda item must disclose their conflicts of interest, and
may answer questions from the IRB about the item with which they have a
conflict, but are prohibited from voting on that item.
What is the term for management controls that are built in to a research study
(for example, independent data analysis)? correct answer -Inherent
controls
