CITI Training Quiz UPDATED ACTUAL
Exam Questions and CORRECT Answers
1. Which of the following are the three principles discussed in the Belmont Report? - CORRECT
ANSWER - 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 ANSWER - 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 ANSWER - Determining that the study
has a maximization of benefits and a minimization of risks.
4. The Data Manager should review the study protocol: - CORRECT ANSWER - to
understand primary and secondary endpoints
5. When designing a database and data collection instruments for a study, the Data Manager
should: - CORRECT ANSWER - 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 ANSWER - False
Which member of a study team is ultimately responsible for the conduct of the study at a site? -
CORRECT ANSWER - 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 ANSWER - The
Clinical Research Associate
, In order for a quality process to work, study team members must understand all of the following
EXCEPT: - CORRECT ANSWER - how to perform the other team members' jobs
Typical study conduct activities performed by the data manager include all of the following
EXCEPT: - CORRECT ANSWER - defining edit checks
At what point should a Data Manager get involved with the database development? - CORRECT
ANSWER - At study startup
Prior to locking a database, a data manager should ensure all data have been entered and all
queries are resolved. - CORRECT ANSWER - 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 ANSWER - 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 ANSWER - Death of Research
Subject (Jesse Gelsinger)
The use of prisoners in research is a concern under the Belmont principle of Justice because:
Exam Questions and CORRECT Answers
1. Which of the following are the three principles discussed in the Belmont Report? - CORRECT
ANSWER - 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 ANSWER - 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 ANSWER - Determining that the study
has a maximization of benefits and a minimization of risks.
4. The Data Manager should review the study protocol: - CORRECT ANSWER - to
understand primary and secondary endpoints
5. When designing a database and data collection instruments for a study, the Data Manager
should: - CORRECT ANSWER - 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 ANSWER - False
Which member of a study team is ultimately responsible for the conduct of the study at a site? -
CORRECT ANSWER - 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 ANSWER - The
Clinical Research Associate
, In order for a quality process to work, study team members must understand all of the following
EXCEPT: - CORRECT ANSWER - how to perform the other team members' jobs
Typical study conduct activities performed by the data manager include all of the following
EXCEPT: - CORRECT ANSWER - defining edit checks
At what point should a Data Manager get involved with the database development? - CORRECT
ANSWER - At study startup
Prior to locking a database, a data manager should ensure all data have been entered and all
queries are resolved. - CORRECT ANSWER - 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 ANSWER - 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 ANSWER - Death of Research
Subject (Jesse Gelsinger)
The use of prisoners in research is a concern under the Belmont principle of Justice because:
