CITI Training Latest Questions and Answers
(Verified Answers)
1. Which of the following are the three principles discussed in the Belmont
Report? - 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: - 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? - ANSWER-Determining that the
study has a maximization of benefits and a minimization of risks.
4. The Data Manager should review the study protocol: - ANSWER-to understand
primary and secondary endpoints
5. When designing a database and data collection instruments for a 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
Every member of a study team must define quality the same way in order to
produce a high quality database. - ANSWER-False
, Which member of a study team is ultimately responsible for the conduct of the
study at a site? - 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? - ANSWER-
The Clinical Research Associate
In order for a quality process to work, study team members must understand all of
the following EXCEPT: - ANSWER-how to perform the other team members' jobs
Typical study conduct activities performed by the data manager include all of the
following EXCEPT: - ANSWER-defining edit checks
At what point should a Data Manager get involved with the database
development? - ANSWER-At study startup
Prior to locking a database, a data manager should ensure all data have been
entered and all queries are resolved. - 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 - ANSWER-Voluntary consent
(Verified Answers)
1. Which of the following are the three principles discussed in the Belmont
Report? - 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: - 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? - ANSWER-Determining that the
study has a maximization of benefits and a minimization of risks.
4. The Data Manager should review the study protocol: - ANSWER-to understand
primary and secondary endpoints
5. When designing a database and data collection instruments for a 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
Every member of a study team must define quality the same way in order to
produce a high quality database. - ANSWER-False
, Which member of a study team is ultimately responsible for the conduct of the
study at a site? - 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? - ANSWER-
The Clinical Research Associate
In order for a quality process to work, study team members must understand all of
the following EXCEPT: - ANSWER-how to perform the other team members' jobs
Typical study conduct activities performed by the data manager include all of the
following EXCEPT: - ANSWER-defining edit checks
At what point should a Data Manager get involved with the database
development? - ANSWER-At study startup
Prior to locking a database, a data manager should ensure all data have been
entered and all queries are resolved. - 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 - ANSWER-Voluntary consent
