CITI TRAINING EXAM STUDY GUIDE | 390 Questions with 100% Correct Answers | 39 Pages
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CITI
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KAPLAN UNIVERSITY
An example of an institutional COI is: - 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: - There may be bias by the p...
citi training exam study guide | 390 questions with 100 correct answers | 39 pages
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CITI TRAINING EXAM STUDY GUIDE | 390
Questions with 100% Correct Answers | 39 Pages
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
, The entity that normally is supposed to determine whether an academic researcher's conflict of
interest can be managed is: Correct Answer: A conflict of interest committee
Which of the following is true about the management of conflicts of interest? Correct 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? Correct
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)? Correct
Answer: To determine compliance with regulatory requirements, including those relating to
protecting research subjects.
Which of the following is true regarding data acquisition? Correct Answer: Data acquisition
should follow a detailed collection plan that is set in advance.
In the research context, the term validity most commonly refers to: Correct Answer: Whether
operationalized terms actually measure what they purport to measure.
Which of the following is true regarding the reporting of research results? Correct Answer:
Clear specification of the methods and procedures used is essential.
Which of the following is true regarding data analysis? Correct Answer: Data analysis methods
should usually be specified in advance before a study begins.
The best time to prepare for an FDA inspection is: Correct Answer: When you are initiating
your study
The protocol, as approved by the IRB, must be followed even in those cases in which the
specified activity would not be performed in a treatment situation except when it is necessary to
eliminate an immediate hazard to human subjects. Correct Answer: True
When a subject signs a consent document, a note in the research record should include: Correct
Answer: All of the above
Which of the following should be part of the FDA inspection process? Correct Answer: All of
the above
Failure to adhere to the protocol and the signed investigator statement/agreement is one of the
most common inspection and audit findings. Correct Answer: True
When an IRB is reviewing a research study and they are considering if a potential subject
population is vulnerable, they should consider: Correct Answer: Is there a power differential
between researchers and subjects?
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