CITI Training Quiz Questions and Answers
(Verified Answers)
1. 1. Which of the following are the three principles discussed in the
Belmont Report (Answer) 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 (Answer) 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 (Answer)
Determining that the study has a maximization of benefits and a
minimization of risks
.
4. 4. The Data Manager should review the study protocol (Answer) 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 (Answer) 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. (Answer) False
7. Which member of a study team is ultimately responsible for the
conduct of the study at a site (Answer) 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 (Answer) - The Clinical Research Associate
9. In order for a quality process to work, study team members must
under- stand all of the following EXCEPT (Answer) how to perform the
other team members' jobs
10.Typical study conduct activities performed by the data manager
include all of the following EXCEPT (Answer) defining edit checks
11.At what point should a Data Manager get involved with the
2/9
, database development (Answer) At study startup
12.Prior to locking a database, a data manager should ensure all data
have been entered and all queries are resolved. (Answer) True
13. Which of the following is included in the Nuremberg Code (Answer)
A. Voluntary consent
B. Confidentiality of data
3/9
(Verified Answers)
1. 1. Which of the following are the three principles discussed in the
Belmont Report (Answer) 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 (Answer) 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 (Answer)
Determining that the study has a maximization of benefits and a
minimization of risks
.
4. 4. The Data Manager should review the study protocol (Answer) 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 (Answer) 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. (Answer) False
7. Which member of a study team is ultimately responsible for the
conduct of the study at a site (Answer) 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 (Answer) - The Clinical Research Associate
9. In order for a quality process to work, study team members must
under- stand all of the following EXCEPT (Answer) how to perform the
other team members' jobs
10.Typical study conduct activities performed by the data manager
include all of the following EXCEPT (Answer) defining edit checks
11.At what point should a Data Manager get involved with the
2/9
, database development (Answer) At study startup
12.Prior to locking a database, a data manager should ensure all data
have been entered and all queries are resolved. (Answer) True
13. Which of the following is included in the Nuremberg Code (Answer)
A. Voluntary consent
B. Confidentiality of data
3/9
