CITI Training Quiz: Questions & Answers
1. Which of the following are the three principles discussed in the Belmont
Report? Correct Ans - Respect for Persons, Beneficence, Justice
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: Correct Ans - Persons with
diminished autonomy are entitled to protection.
3. Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects? Correct Ans -
Determining that the study has a maximization of benefits and a minimization
of risks.
4. The Data Manager should review the study protocol: Correct Ans -
to understand primary and secondary endpoints
5. When designing a database and data collection instruments for a study, the
Data Manager should: Correct Ans - Use standards to reduce the time
required to set up the database and to increase the consistency of the data
Every member of a study team must define quality the same way in order to
produce a high quality database. Correct Ans - False
Which member of a study team is ultimately responsible for the conduct of the
study at a site? Correct Ans - The Investigator
Which member of a study team acts as the liaison between a sponsor and site,
ensuring that reported data are verifiable to source documentation?
Correct Ans - The Clinical Research Associate
In order for a quality process to work, study team members must understand
all of the following EXCEPT: Correct Ans - how to perform the other
team members' jobs
Typical study conduct activities performed by the data manager include all of
the following EXCEPT: Correct Ans - defining edit checks
, At what point should a Data Manager get involved with the database
development? Correct Ans - At study startup
Prior to locking a database, a data manager should ensure all data have been
entered and all queries are resolved. Correct Ans - True
Which of the following is included in the Nuremberg Code:
A. Voluntary consent
B. Confidentiality of data
C. Equitable selection of subjects
D. Additional protection for vulnerable subjects Correct Ans -
Voluntary consent
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 Correct Ans - Death of
Research Subject (Jesse Gelsinger)
The use of prisoners in research is a concern under the Belmont principle of
Justice because:
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 Correct Ans - Prisoners may not be used to
conduct research that only benefits the larger society
Informed consent is considered an application of which Belmont principle?
A. Beneficence
B. Justice
1. Which of the following are the three principles discussed in the Belmont
Report? Correct Ans - Respect for Persons, Beneficence, Justice
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: Correct Ans - Persons with
diminished autonomy are entitled to protection.
3. Which of the following is an example of how the principle of beneficence
can be applied to a study employing human subjects? Correct Ans -
Determining that the study has a maximization of benefits and a minimization
of risks.
4. The Data Manager should review the study protocol: Correct Ans -
to understand primary and secondary endpoints
5. When designing a database and data collection instruments for a study, the
Data Manager should: Correct Ans - Use standards to reduce the time
required to set up the database and to increase the consistency of the data
Every member of a study team must define quality the same way in order to
produce a high quality database. Correct Ans - False
Which member of a study team is ultimately responsible for the conduct of the
study at a site? Correct Ans - The Investigator
Which member of a study team acts as the liaison between a sponsor and site,
ensuring that reported data are verifiable to source documentation?
Correct Ans - The Clinical Research Associate
In order for a quality process to work, study team members must understand
all of the following EXCEPT: Correct Ans - how to perform the other
team members' jobs
Typical study conduct activities performed by the data manager include all of
the following EXCEPT: Correct Ans - defining edit checks
, At what point should a Data Manager get involved with the database
development? Correct Ans - At study startup
Prior to locking a database, a data manager should ensure all data have been
entered and all queries are resolved. Correct Ans - True
Which of the following is included in the Nuremberg Code:
A. Voluntary consent
B. Confidentiality of data
C. Equitable selection of subjects
D. Additional protection for vulnerable subjects Correct Ans -
Voluntary consent
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 Correct Ans - Death of
Research Subject (Jesse Gelsinger)
The use of prisoners in research is a concern under the Belmont principle of
Justice because:
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 Correct Ans - Prisoners may not be used to
conduct research that only benefits the larger society
Informed consent is considered an application of which Belmont principle?
A. Beneficence
B. Justice
