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