CITI TRAINING- Questions With All Correct Answers
An example of an institutional COI is: correct answer -An industry sponsor
pays for the construction of a new research laboratory at the organization
The peer review process can create conflicts 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
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
A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because: correct answer -It may be
difficult for the researcher to appear neutral, as the researcher may have an
interest in the research's success
The FDA regulations governing disclosure of individual COIs require:
correct answer -Applicants submitting marketing applications to disclose
financial COIs of researchers who conducted clinical studies
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.
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
For clinical trials, what should be reported to the Office for Clinical Research
(OCR) to confirm ClinicalTrials.gov registration and for the purpose of
ensuring Medicare reimbursement? correct answer -NCT number
The Sunshine Act requires manufacturers to report "payments of transfers of
value" for how much annually? correct answer -$10.00
,Which department reviews a sample of clinical trials being conducted in each
department and provides education, tools, and corrective and preventative
action plans, when needed? correct answer -Clinical Trials Audit and
Compliance
Getting your proposal prepared for review and approval can be cumbersome.
Which department in the Office of Research Administration assists with
proposal preparation? correct answer -Research Administration Services
(RAS)
Which best matches the NIH definition of a clinical trial? correct answer -A
research study in which one or more humans subjects are assigned to
evaluate the effects of those interventions involving health-related biomedical
and behavioral outcomes.
Adjudication of research participant's bills allows which department to direct
charges to the correct payer? correct answer -Clinical Trials Billing
Department (CTBD)
To facilitate Pre-award submissions and their approval, the study team should
submit to the Institutional Review Board (IRB) at the same time they are
submitting to OCR, and OSP/OTT. correct answer -True
Non-licensed clinicians can dispense and educate subjects about their
medication. correct answer -False
Which system provides the status of a clinical trial agreement (CTA)?
correct answer -Emory Contracts Tracking System (eCTS)
If the FDA schedules an appointment to inspect your studies, which
department at Emory should you contact first in preparation for the FDA visit?
correct answer -Office of Compliance
How often should research administrators or PIs initiate a routine "New
Proposal Financial Interest in Research Report" for each project in eCOI?
correct answer -Annually
,The Prospective Reimbursement Analysis (PRA) and a Medicare Coverage
Analysis (MCA) are used interchangeably. At Emory, the purpose of the PRA is
to assist with research billing compliance, which is correct answer -Billing
the appropriate party (i.e. Medicare, Insurance, or a grant) for subjects
involved in a research study.
When patients receive a copy of an organization's privacy notice, why are they
asked to sign an acknowledgment? correct answer -It shows they received
it.
HIPAA's "incidental uses and disclosures" provision excuses deviations from
the minimum necessary standard. What is excused? correct answer -Truly
accidental "excess" uses and disclosures, where reasonable caution was
otherwise used and there was no negligence.
What kinds of persons and organizations are affected by HIPAA's
requirements? correct answer -Healthcare providers, health plans, and
health information clearinghouses, as well as their business associates and by
extension the workers for those organizations.
With respect to permissions for uses and disclosures, HIPAA divides health
information into three categories. Into which category does information
related to research, marketing, and fundraising go? correct answer -Uses
or disclosures that generally require specific written authorization.
HIPAA privacy protections cover identifiable personal information about the
"past, present or future physical or mental health condition." What does that
include? correct answer -Health information in any form or medium, as
long as it is identified (or identifiable) as a particular person's information.
Which of the following statements is true regarding the International
Committee of Medical Journal Editors (ICMJE) guidelines? correct answer -
Individuals who do not meet the criteria for authorship but who have made a
noteworthy contribution are normally listed in the acknowledgments section.
Which author is normally responsible for sharing reprints of a publication
with readers? correct answer -The corresponding author.
, Which of the following is true regarding an acknowledgments section?
correct answer -The contributions of technicians and other researchers are
often listed in the acknowledgments section if they do not meet all of the
criteria for authorship.
Which of the following most accurately describes the practice of ghost
authorship? correct answer -It is a situation where the individual who
wrote the manuscript is not listed as an author.
Which of the following statements is true regarding authorship practices?
correct answer -Different disciplines have different practices about who
should be included as an author.
What is the main function of the Bayh-Dole Act of 1980 as it relates to
academic institutions? correct answer -It allows institutions to have
control over the intellectual property from federally-funded research.
The most important factor determining whether a research collaboration will
be successful is: correct answer -Whether there is ongoing communication
about goals and responsibilities.
A research collaboration can be enhanced by: correct answer -Discussing
intellectual property issues while the collaboration is forming.
What is the most appropriate process for determining which journal a
collaborative research team should submit their work to? correct answer -
The research team should discuss the issue early on and while the project is
ongoing.
Data ownership is typically determined by: correct answer -The type and
source of funds used to support the project.
Which of the following most accurately describes a conflict of commitment?
correct answer -It occurs when outside activities interfere with obligations
to one's primary employer.
The main focus of NIH's conflict of interest policy is: correct answer -
Financial conflicts of interest
An example of an institutional COI is: correct answer -An industry sponsor
pays for the construction of a new research laboratory at the organization
The peer review process can create conflicts 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
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
A researcher's membership on an advisory board with an organization
sponsoring research can create a COI because: correct answer -It may be
difficult for the researcher to appear neutral, as the researcher may have an
interest in the research's success
The FDA regulations governing disclosure of individual COIs require:
correct answer -Applicants submitting marketing applications to disclose
financial COIs of researchers who conducted clinical studies
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.
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
For clinical trials, what should be reported to the Office for Clinical Research
(OCR) to confirm ClinicalTrials.gov registration and for the purpose of
ensuring Medicare reimbursement? correct answer -NCT number
The Sunshine Act requires manufacturers to report "payments of transfers of
value" for how much annually? correct answer -$10.00
,Which department reviews a sample of clinical trials being conducted in each
department and provides education, tools, and corrective and preventative
action plans, when needed? correct answer -Clinical Trials Audit and
Compliance
Getting your proposal prepared for review and approval can be cumbersome.
Which department in the Office of Research Administration assists with
proposal preparation? correct answer -Research Administration Services
(RAS)
Which best matches the NIH definition of a clinical trial? correct answer -A
research study in which one or more humans subjects are assigned to
evaluate the effects of those interventions involving health-related biomedical
and behavioral outcomes.
Adjudication of research participant's bills allows which department to direct
charges to the correct payer? correct answer -Clinical Trials Billing
Department (CTBD)
To facilitate Pre-award submissions and their approval, the study team should
submit to the Institutional Review Board (IRB) at the same time they are
submitting to OCR, and OSP/OTT. correct answer -True
Non-licensed clinicians can dispense and educate subjects about their
medication. correct answer -False
Which system provides the status of a clinical trial agreement (CTA)?
correct answer -Emory Contracts Tracking System (eCTS)
If the FDA schedules an appointment to inspect your studies, which
department at Emory should you contact first in preparation for the FDA visit?
correct answer -Office of Compliance
How often should research administrators or PIs initiate a routine "New
Proposal Financial Interest in Research Report" for each project in eCOI?
correct answer -Annually
,The Prospective Reimbursement Analysis (PRA) and a Medicare Coverage
Analysis (MCA) are used interchangeably. At Emory, the purpose of the PRA is
to assist with research billing compliance, which is correct answer -Billing
the appropriate party (i.e. Medicare, Insurance, or a grant) for subjects
involved in a research study.
When patients receive a copy of an organization's privacy notice, why are they
asked to sign an acknowledgment? correct answer -It shows they received
it.
HIPAA's "incidental uses and disclosures" provision excuses deviations from
the minimum necessary standard. What is excused? correct answer -Truly
accidental "excess" uses and disclosures, where reasonable caution was
otherwise used and there was no negligence.
What kinds of persons and organizations are affected by HIPAA's
requirements? correct answer -Healthcare providers, health plans, and
health information clearinghouses, as well as their business associates and by
extension the workers for those organizations.
With respect to permissions for uses and disclosures, HIPAA divides health
information into three categories. Into which category does information
related to research, marketing, and fundraising go? correct answer -Uses
or disclosures that generally require specific written authorization.
HIPAA privacy protections cover identifiable personal information about the
"past, present or future physical or mental health condition." What does that
include? correct answer -Health information in any form or medium, as
long as it is identified (or identifiable) as a particular person's information.
Which of the following statements is true regarding the International
Committee of Medical Journal Editors (ICMJE) guidelines? correct answer -
Individuals who do not meet the criteria for authorship but who have made a
noteworthy contribution are normally listed in the acknowledgments section.
Which author is normally responsible for sharing reprints of a publication
with readers? correct answer -The corresponding author.
, Which of the following is true regarding an acknowledgments section?
correct answer -The contributions of technicians and other researchers are
often listed in the acknowledgments section if they do not meet all of the
criteria for authorship.
Which of the following most accurately describes the practice of ghost
authorship? correct answer -It is a situation where the individual who
wrote the manuscript is not listed as an author.
Which of the following statements is true regarding authorship practices?
correct answer -Different disciplines have different practices about who
should be included as an author.
What is the main function of the Bayh-Dole Act of 1980 as it relates to
academic institutions? correct answer -It allows institutions to have
control over the intellectual property from federally-funded research.
The most important factor determining whether a research collaboration will
be successful is: correct answer -Whether there is ongoing communication
about goals and responsibilities.
A research collaboration can be enhanced by: correct answer -Discussing
intellectual property issues while the collaboration is forming.
What is the most appropriate process for determining which journal a
collaborative research team should submit their work to? correct answer -
The research team should discuss the issue early on and while the project is
ongoing.
Data ownership is typically determined by: correct answer -The type and
source of funds used to support the project.
Which of the following most accurately describes a conflict of commitment?
correct answer -It occurs when outside activities interfere with obligations
to one's primary employer.
The main focus of NIH's conflict of interest policy is: correct answer -
Financial conflicts of interest
