CITI Training Quiz Questions and Answers

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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 / 3

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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 / 3

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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

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