CITI Training Quiz Questions

CITI Training Quiz Questions

1. Which of the following are the three principles discussed in the Belmont Report? -

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: - 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? - Determining that the study has a maximization of

benefits and a minimization of risks.

4. The Data Manager should review the study protocol: - to understand primary and

secondary endpoints

5. When designing a database and data collection instruments for a study, the Data

Manager should: - 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. - False

Which member of a study team is ultimately responsible for the conduct of the study at a

site? - 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? - The Clinical Research Associate

In order for a quality process to work, study team members must understand all of the

following EXCEPT: - how to perform the other team members' jobs

Typical study conduct activities performed by the data manager include all of the following

EXCEPT: - defining edit checks

At what point should a Data Manager get involved with the database development? - At

study startup

Prior to locking a database, a data manager should ensure all data have been entered and

all queries are resolved. - 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 - 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 - 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 - Prisoners may not be used to conduct research that only benefits

the larger society

Informed consent is considered an application of which Belmont principle?

A. Beneficence

B. Justice

C. Non-maleficence

D. Respect for Persons - Respect for persons

Which of the following was the result of the Beecher article?

A. Additional FDA regulations

B. Realization that ethical abuses are not limited to the Nazi regime

C. An identification of basic ethical principles

D. Multiple Congressional hearings - Realization that ethical abuses are not limited to the

Nazi regime

Which of the following statements is accurate in determining subject risk involved in a

genetic study: - Understanding the purpose and context of a specific study is critical in

determining the risk involved

As of January 2015, the NIH expects investigators to obtain the informed (valid) consent of

research participants in NIH -funded genetic research for broad research use of data and

data sharing, even if the cell lines or specimens are: - De-Identified