Citi Training Questions and Correct Answers | Latest
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Why are institutionally provisioned technology systems (in other words,
systems provided through a university, hospital, or clinic) generally more
secure than consumer products?
Ans: Because information technology professionals have vetted them
with the vendor.
When would an IRB consider the risks of a study to be controlled?
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Ans: When there is an appropriate risk mitigation and management plan
in place.
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What existing federal regulations define technology-based risk
assessment?
Ans: None of the above
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Why do custom-built, homegrown, and/or investigational technologies
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pose the greatest risk to research participants?
Ans: Because researchers cannot know all the potential risks until
participants have used the technology in practice.
How can a Bring Your Own Device (BYOD) study approach reduce or
mitigate technology-related risks?
Ans: The participant may already know the risks of using the device if
they are familiar with it for personal use. This decision indicates a level
of pre-research risk acceptance.
Data lifecycle management refers to what?
Ans: The ongoing oversight of research data by the researchers for the
study's duration
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Instead of "data will be stored on the researcher's computer," what
should a strong data security plan state?
Ans: Data will be stored on an encrypted computer with a strong
password that only the researcher knows.
What is passive mobile data collection?
Ans: Data collection that occurs on the device that the researcher and
participant are unaware of
Which of the following is an example of how the principle of beneficence
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can be applied to a study employing human subjects?
Ans: Determining that the study has a maximization of benefits and a
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minimization of risks.
The Belmont Report's principle of respect for persons incorporates at
least two ethical convictions: first, that individuals should be treated as
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autonomous agents, and second, that
Ans: Persons with diminished autonomy are entitled to protection
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Which of the following are the three principles discussed in the Belmont
Report?
Ans: Respect for Persons, Beneficence, Justice
The two exempt research categories that always require limited IRB
review as a condition of exemption are: Storage or maintenance for
secondary research for which broad consent is required (Category 7) and
which of the following?
Ans: Secondary research for which broad consent is required (Category
8)
The Final Rule added a definition for three new terms, including: clinical
trial, written or in writing, and:
, 3 for specific request mail
Ans: Public health authority
The Final Rule made revisions to the following definition:
Ans: Human subject
The following category of research was added to the "Exempt Research"
section at 46.104:
Ans: Benign behavioral interventions
The compliance date for cooperative review is:
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Ans: Three years from publishing the 2017 Final Rule in the Federal
Register
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Broad consent for storage, maintenance, and secondary research use may
be obtained:
Ans: In lieu of a full informed consent
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The definition of "research" was expanded to:
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Ans: List activities that are specifically deemed not to be research
Research approved on 1 September 2019 conducted by a regulated entity
would be subject to:
Ans: Final Rule (2018 Requirements)
The Final Rule made revisions to the following definition:
Ans: Human subject
The Final Rule revised the definition of "written or in writing" to clarify:
Ans: That these terms include electronic formats
A researcher submits a study to the IRB that proposes to evaluate a new
after-school on-line tutoring program for middle-school students in a