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Citi Training Exam Practice | 88 Questions with 100% Correct Answers
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What is the term for management controls that are built in to a research study (for example, independent data analysis)? - Inherent controls An example of an individual financial COI is: - A researcher's wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the r...

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  • October 3, 2022
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  • citi training exam practice | 88 questions with 100 correct answers

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Citi Training Exam Practice | 88 Questions with 100% 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

An example of an individual financial 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.

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

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

The COI management plan aims to: Correct Answer: Provide procedures or extras steps to be
taken to minimize the risk of bias when a COI is disclosed

An example of an institutional COI is: Correct Answer: An industry sponsor pays for the
construction of a new research laboratory at the organization

An example of an individual financial 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.

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

The PHS regulations about financial conflict of interests require which party to disclose
significant financial conflicts of interest? Correct Answer: Researcher

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

Correct Answer:

Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout
is an example of a violation of the principle of: Correct Answer: Respect for persons.

Which of the following studies is linked most directly to the establishment of the National
Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human
subject protection? Correct Answer: The Public Health Service Tuskegee Study of Untreated
Syphilis in the Negro Male.

, The researcher's failure to protect research subjects from deductive disclosure is the primary
ethical violation in which of the following studies? Correct Answer: Harvard "Tastes, Ties, and
Time (T3)" study (2006-2009)" study

According to the Belmont Report, the moral requirement that there be fair outcomes in the
selection of research subjects, expresses the principle of: Correct Answer: Justice

Which of the following is an example of how the principle of beneficence is applied to a study
involving human subjects? Correct Answer: Ensuring that risks are reasonable in relationship to
anticipated benefits.

Correct Answer:

According to the federal regulations, human subjects are living human beings about whom an
investigator obtains data through interaction or intervention with the individual or: Correct
Answer: Identifiable private information.

A medical record is an example of: Correct Answer: Private information.

According to the federal regulations, which of the following studies meets the definition of
research with human subjects? Correct Answer: A cognitive psychologist enrolls undergraduate
students for a computer-based study about the effect of mood on problem solving behaviors.

According to the federal regulations, which of the following studies meets the definition of
research with human subjects? Correct Answer: A developmental psychologist videotapes
interactions between groups of toddlers and their care givers to determine which intervention
methods most effectively manage aggression.

According to the federal regulations, which of the following studies meets the definition of
research with human subjects? Correct Answer: A study of twenty 4th grade classrooms in
which researchers ask the schools to systematically vary the time of day reading is taught, and
collect weekly assessments of reading comprehension for each child over a three-month period.

According to federal regulations, the expedited review process may be used when the study
procedures pose: Correct Answer: No more than minimal risk and the research activities fall
within regulatory categories identified as eligible.

According to the federal regulations, research is eligible for exemption, if Correct Answer: The
research falls into one of six categories of research activity described in the regulations.

Continuing review of an approved and ongoing protocol Correct Answer: Must occur within 12
months of the approval date.

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