CITI Training Quiz Practice Questions And Solutions
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Course
CITI Training
Institution
CITI Training
CITI Training Quiz Practice Questions And
Solutions
Which of the following statements in a consent form is an example of exculpatory
language?
A. In the event of any injury related to this research, you will be given medical
treatment.
B. Your participation in this research is voluntary. I...
CITI Training Quiz Practice Questions And
Solutions
Which of the following statements in a consent form is an example of exculpatory
language?
A. In the event of any injury related to this research, you will be given medical
treatment.
B. Your participation in this research is voluntary. If you choose not to participate,
or change your mind later, your decision will not affect your relationship with your
doctor or your right to health care or other services that you may be eligible for.
C. The investigator may stop you from participating in this research without your
consent if you experience side effects that make your condition worse. If you
become ill during the research, you may have to drop out.
D. I waive any possibility of compensation for injuries that I may receive as a
result of participation in this research. - ANSWER -I waive any possibility of
compensation for injuries that I may receive as a result of participation in this
research.
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe
diabetic neuropathy. While the study is ongoing, a new drug becomes
commercially available that may have equal or greater benefit to the subject. The
investigator should do which of the following?
A. Discuss the pros and cons of both the investigational drug and the commercially
available drug and then allow the subject to decide whether to withdraw from the
research to take the new drug.
B. Tell the subject about the new drug but discourage him from switching
treatments until the study is completed
C. Withhold this new information to avoid confusing the subject with other
treatment options or alternatives
D. Do not tell the subject about the new drug since physicians have the right to try
out new treatments with their patients - ANSWER -Discuss the pros and cons of
, both the investigational drug and the commercially available drug and then allow
the subject to decide whether to withdraw from the research to take the new drug.
A researcher wants to conduct a secondary analysis using a Centers for Disease
Control and Prevention (CDC) database that was collected by the agency solely for
surveillance purposes from 1996-2006. The researcher did not participate in the
initial collection of the data. The database is publicly available. The database does
not include any identifiers. The IRB makes a determination that the individuals
whose records will be reviewed do not meet the federal definition of human
subjects.
Which of the following considerations was relevant to the IRB's determination that
this activity does not constitute research with human subjects? - ANSWER -The
researcher will not be interacting/intervening with subjects and the data has no
identifiers.
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
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