CITI Training Quiz Questions and Answers
(Verified Answers)
1. 1. Which of the following are the three principles discussed in the
Belmont Report>>Respect for Persons, Beneficence, Justice
2. 2. The Belmont Report's principle of respect for persons
incorporates at least two ethical convictions first, that individuals should
be treated as
autonomous agents, and second, that>>Persons with diminished
autonomy are entitled to protection.
3. 3. Which of the following is an example of how the principle of
beneficence can be applied to a study employing human
subjects>>Determining that the study has a maximization of benefits
and a minimization of risks
.
4. 4. The Data Manager should review the study protocol>>to
understand primary and secondary endpoints
5. 5. When designing a database and data collection instruments for a
1/9
,study, the Data Manager should>>Use standards to reduce the time
required to set up the database and to increase the consistency of the
data
6. Every member of a study team must define quality the same way in
order to produce a high quality database.>>False
7. Which member of a study team is ultimately responsible for the
conduct of the study at a site>>The Investigator
8. Which member of a study team acts as the liaison between a sponsor
and site, ensuring that reported data are verifiable to source
documentation>>- The Clinical Research Associate
9. In order for a quality process to work, study team members must
under- stand all of the following EXCEPT>>how to perform the other
team members' jobs
10.Typical study conduct activities performed by the data manager
include all of the following EXCEPT>>defining edit checks
11.At what point should a Data Manager get involved with the
2/9
,database development>>At study startup
12.Prior to locking a database, a data manager should ensure all data
have been entered and all queries are resolved.>>True
13. Which of the following is included in the Nuremberg Code (Answer)
A. Voluntary consent
B. Confidentiality of data
3/9
,C. Equitable selection of subjects
D. Additional protection for vulnerable subjects>>Voluntary consent
14. Which of the following brought increased public attention to the
problems with the IRB system?
A. Death of Research Subject (Jesse Gelsinger)
B. "Shut Downs" by OHRP
C. HHS Inspector General Report of 1998
D. 1983 Presidential Commission Report>>Death of Research Subject
(Jesse Gelsinger)
15. The use of prisoners in research is a concern under the Belmont
principle of Justice because (Answer)
A. Prisoners are not a representative sample of the general population
B. Prisoners are not free to say no
C. Prisoners may not be used to conduct research that only benefits
the larger society
D. Prisoners are less educated that the general population and have
difficulty understanding research>>Prisoners may not be used to
conduct research that only benefits the larger society
16. Informed consent is considered an application of which Belmont
princi- ple?
A. Beneficence
B. Justice
4/9
, C. Non-maleficence
D. Respect for Persons>>Respect for persons
17. Which of the following was the result of the Beecher article?
A. Additional FDA regulations
B. Realization that ethical abuses are not limited to the Nazi regime
C. An identification of basic ethical principles
D. Multiple Congressional hearings>>Realization that ethical abuses
are not limited to the Nazi regime
18.Which of the following statements is accurate in determining subject
risk involved in a genetic study>>Understanding the purpose and context
of a specific study is critical in determining the risk involved
5/9
(Verified Answers)
1. 1. Which of the following are the three principles discussed in the
Belmont Report>>Respect for Persons, Beneficence, Justice
2. 2. The Belmont Report's principle of respect for persons
incorporates at least two ethical convictions first, that individuals should
be treated as
autonomous agents, and second, that>>Persons with diminished
autonomy are entitled to protection.
3. 3. Which of the following is an example of how the principle of
beneficence can be applied to a study employing human
subjects>>Determining that the study has a maximization of benefits
and a minimization of risks
.
4. 4. The Data Manager should review the study protocol>>to
understand primary and secondary endpoints
5. 5. When designing a database and data collection instruments for a
1/9
,study, the Data Manager should>>Use standards to reduce the time
required to set up the database and to increase the consistency of the
data
6. Every member of a study team must define quality the same way in
order to produce a high quality database.>>False
7. Which member of a study team is ultimately responsible for the
conduct of the study at a site>>The Investigator
8. Which member of a study team acts as the liaison between a sponsor
and site, ensuring that reported data are verifiable to source
documentation>>- The Clinical Research Associate
9. In order for a quality process to work, study team members must
under- stand all of the following EXCEPT>>how to perform the other
team members' jobs
10.Typical study conduct activities performed by the data manager
include all of the following EXCEPT>>defining edit checks
11.At what point should a Data Manager get involved with the
2/9
,database development>>At study startup
12.Prior to locking a database, a data manager should ensure all data
have been entered and all queries are resolved.>>True
13. Which of the following is included in the Nuremberg Code (Answer)
A. Voluntary consent
B. Confidentiality of data
3/9
,C. Equitable selection of subjects
D. Additional protection for vulnerable subjects>>Voluntary consent
14. Which of the following brought increased public attention to the
problems with the IRB system?
A. Death of Research Subject (Jesse Gelsinger)
B. "Shut Downs" by OHRP
C. HHS Inspector General Report of 1998
D. 1983 Presidential Commission Report>>Death of Research Subject
(Jesse Gelsinger)
15. The use of prisoners in research is a concern under the Belmont
principle of Justice because (Answer)
A. Prisoners are not a representative sample of the general population
B. Prisoners are not free to say no
C. Prisoners may not be used to conduct research that only benefits
the larger society
D. Prisoners are less educated that the general population and have
difficulty understanding research>>Prisoners may not be used to
conduct research that only benefits the larger society
16. Informed consent is considered an application of which Belmont
princi- ple?
A. Beneficence
B. Justice
4/9
, C. Non-maleficence
D. Respect for Persons>>Respect for persons
17. Which of the following was the result of the Beecher article?
A. Additional FDA regulations
B. Realization that ethical abuses are not limited to the Nazi regime
C. An identification of basic ethical principles
D. Multiple Congressional hearings>>Realization that ethical abuses
are not limited to the Nazi regime
18.Which of the following statements is accurate in determining subject
risk involved in a genetic study>>Understanding the purpose and context
of a specific study is critical in determining the risk involved
5/9
