CITI TRAINING COMPREHENSIVE EXAM
TEST PAPER WITH SOLVED QUESTIONS
GRADED A+
◉ An investigator conducting a study of a medical device under an
IDE is required to complete and sign which of the following?
Answer: An investigator's agreement
◉ A 510(k) Premarket Notification is submitted:
Answer: When the new device to be marketed is substantially
similar (equivalent) to one already on the market
◉ Evaluation of Unanticipated Adverse Device Effects (UADEs)
must be reported to the FDA by the:
Answer: Sponsor
◉ An investigator is confronted with a life-threatening situation
that necessitates using a test article in a human subject who is
unable to provide informed consent and there is no time to obtain
consent for the individual's legal representative. Under the FDA
regulations, which of the following describes the best course of
action for the investigator:
Sign the consent form on behalf of the subject and use the test
article.
, Submit a research protocol to the IRB and justify an expedited
review approval of the consent document so the test article can be
used immediately.
Do not use the test article until either the subject or the subject's
legally authorized representative can give consent.
The investigator and another physician not part of the study team
agree that the situation necessitates the use of the test article and
the IRB will be notified later.
Answer: The investigator and another physician not part of the
study team agree that the situation necessitates the use of the test
article and the IRB will be notified later.
◉ Which of the following statements in a consent form is an
example of exculpatory language?
Answer: I waive any possibility of compensation for injuries that I
may receive as a result of participation in this research.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?
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
TEST PAPER WITH SOLVED QUESTIONS
GRADED A+
◉ An investigator conducting a study of a medical device under an
IDE is required to complete and sign which of the following?
Answer: An investigator's agreement
◉ A 510(k) Premarket Notification is submitted:
Answer: When the new device to be marketed is substantially
similar (equivalent) to one already on the market
◉ Evaluation of Unanticipated Adverse Device Effects (UADEs)
must be reported to the FDA by the:
Answer: Sponsor
◉ An investigator is confronted with a life-threatening situation
that necessitates using a test article in a human subject who is
unable to provide informed consent and there is no time to obtain
consent for the individual's legal representative. Under the FDA
regulations, which of the following describes the best course of
action for the investigator:
Sign the consent form on behalf of the subject and use the test
article.
, Submit a research protocol to the IRB and justify an expedited
review approval of the consent document so the test article can be
used immediately.
Do not use the test article until either the subject or the subject's
legally authorized representative can give consent.
The investigator and another physician not part of the study team
agree that the situation necessitates the use of the test article and
the IRB will be notified later.
Answer: The investigator and another physician not part of the
study team agree that the situation necessitates the use of the test
article and the IRB will be notified later.
◉ Which of the following statements in a consent form is an
example of exculpatory language?
Answer: I waive any possibility of compensation for injuries that I
may receive as a result of participation in this research.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?
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
