CITI Training Quiz Questions and 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? - AnswerThe 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' jobsTypical 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 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 - Answer-Death of Research Subject (Jesse Gelsinger) The use of prisoners in research is a concern under the Belmont principle of Justice because: A. Prisoners are not a representative sample of the general population B. Prisoners are not free to say no C. Prisoners may not be used to conduct research that only benefits the larger society D. Prisoners are less educated that the general population and have difficulty understanding research - Answer-Prisoners may not be used to conduct research that only benefits the larger societyInformed consent is considered an application of which Belmont principle? A. Beneficence B. Justice C. Non-maleficence D. Respect for Persons - Answer-Respect for persons