CITI TRAINING | FROM QUESTION TO PERFECTION|
STUDY WITH CONFIDENCE!
Course Code:
Course Title:
Programme:
Academic Year: 2026/2027.
Duration: 2 Hours.
Total Marks: 100.
Candidate Instructions:
1) Write your Registration Number on every answer booklet used.
2) Answer ALL questions in Section A and ANY TWO (2) questions in Section B.
3) Read each question carefully before answering.
4) Begin each question on a new page.
5) The marks for each question are indicated in brackets.
6) This paper consists of several printed pages, including this page.
7) Ensure your copy is complete before the examination begins.
8) Unauthorized materials and communication with other candidates are not permitted.
Turn Over.
APPHIA – Crafted with Care and Precision for Academic Excellence.
1
,An example of an institutional COI is: 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: 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: 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: 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: Answer: Applicants
submitting marketing applications to disclose financial COIs of researchers who conducted
clinical studies
An example of an individual financial COI is: 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. 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?
Answer: NCT number
The Sunshine Act requires manufacturers to report "payments of transfers of value" for how
much annually? 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? 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? Answer: Research
Administration Services (RAS)
Which best matches the NIH definition of a clinical trial? 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.
APPHIA – Crafted with Care and Precision for Academic Excellence.
2
,Adjudication of research participant's bills allows which department to direct charges to the
correct payer? 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.
Answer: True
Non-licensed clinicians can dispense and educate subjects about their medication. Answer:
False
Which system provides the status of a clinical trial agreement (CTA)? 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? 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? 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 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? Answer: It shows they received it.
HIPAA's "incidental uses and disclosures" provision excuses deviations from the minimum
necessary standard. What is excused? 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? 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? 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? 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? Answer: Individuals who do not meet the criteria for
authorship but who have made a noteworthy contribution are normally listed in the
acknowledgments section.
APPHIA – Crafted with Care and Precision for Academic Excellence.
3
, Which author is normally responsible for sharing reprints of a publication with readers?
Answer: The corresponding author.
Which of the following is true regarding an acknowledgments section? 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? 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? 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?
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:
Answer: Whether there is ongoing communication about goals and responsibilities.
A research collaboration can be enhanced by: 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? Answer: The research team should discuss the issue early on
and while the project is ongoing.
Data ownership is typically determined by: Answer: The type and source of funds used to
support the project.
Which of the following most accurately describes a conflict of commitment? 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: Answer: Financial conflicts of interest
The entity that normally is supposed to determine whether an academic researcher's conflict of
interest can be managed is: Answer: A conflict of interest committee
Which of the following is true about the management of conflicts of interest? Answer:
Management plans are often created to reduce the impact of conflicts of interest.
Which of the following most accurately describes an institutional conflict of interest? Answer:
It occurs when an institution's financial or non-financial interests could interfere with its
research activities.
What is the primary responsibility of oversight bodies (such as an IRB or IACUC)? Answer: To
determine compliance with regulatory requirements, including those relating to protecting
research subjects.
APPHIA – Crafted with Care and Precision for Academic Excellence.
4
STUDY WITH CONFIDENCE!
Course Code:
Course Title:
Programme:
Academic Year: 2026/2027.
Duration: 2 Hours.
Total Marks: 100.
Candidate Instructions:
1) Write your Registration Number on every answer booklet used.
2) Answer ALL questions in Section A and ANY TWO (2) questions in Section B.
3) Read each question carefully before answering.
4) Begin each question on a new page.
5) The marks for each question are indicated in brackets.
6) This paper consists of several printed pages, including this page.
7) Ensure your copy is complete before the examination begins.
8) Unauthorized materials and communication with other candidates are not permitted.
Turn Over.
APPHIA – Crafted with Care and Precision for Academic Excellence.
1
,An example of an institutional COI is: 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: 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: 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: 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: Answer: Applicants
submitting marketing applications to disclose financial COIs of researchers who conducted
clinical studies
An example of an individual financial COI is: 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. 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?
Answer: NCT number
The Sunshine Act requires manufacturers to report "payments of transfers of value" for how
much annually? 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? 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? Answer: Research
Administration Services (RAS)
Which best matches the NIH definition of a clinical trial? 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.
APPHIA – Crafted with Care and Precision for Academic Excellence.
2
,Adjudication of research participant's bills allows which department to direct charges to the
correct payer? 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.
Answer: True
Non-licensed clinicians can dispense and educate subjects about their medication. Answer:
False
Which system provides the status of a clinical trial agreement (CTA)? 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? 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? 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 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? Answer: It shows they received it.
HIPAA's "incidental uses and disclosures" provision excuses deviations from the minimum
necessary standard. What is excused? 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? 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? 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? 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? Answer: Individuals who do not meet the criteria for
authorship but who have made a noteworthy contribution are normally listed in the
acknowledgments section.
APPHIA – Crafted with Care and Precision for Academic Excellence.
3
, Which author is normally responsible for sharing reprints of a publication with readers?
Answer: The corresponding author.
Which of the following is true regarding an acknowledgments section? 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? 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? 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?
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:
Answer: Whether there is ongoing communication about goals and responsibilities.
A research collaboration can be enhanced by: 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? Answer: The research team should discuss the issue early on
and while the project is ongoing.
Data ownership is typically determined by: Answer: The type and source of funds used to
support the project.
Which of the following most accurately describes a conflict of commitment? 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: Answer: Financial conflicts of interest
The entity that normally is supposed to determine whether an academic researcher's conflict of
interest can be managed is: Answer: A conflict of interest committee
Which of the following is true about the management of conflicts of interest? Answer:
Management plans are often created to reduce the impact of conflicts of interest.
Which of the following most accurately describes an institutional conflict of interest? Answer:
It occurs when an institution's financial or non-financial interests could interfere with its
research activities.
What is the primary responsibility of oversight bodies (such as an IRB or IACUC)? Answer: To
determine compliance with regulatory requirements, including those relating to protecting
research subjects.
APPHIA – Crafted with Care and Precision for Academic Excellence.
4
