CITI TRAINING GOOD CLINICAL PRACTICE E
QUESTIONS AND DETAILED SOLUTIONS
◉ When must the investigator update the IRB about the progress of
a trial?
Answer: During the conduct of the study and at termination
◉ Form FDA 1572, Statement of Investigator, is legally binding
between the investigator and the:
Answer: FDA
◉ The investigator must report adverse events to the:
Answer: Sponser
◉ In completing Form FDA 1572, Statement of Investigator, the
investigator agrees to
Answer: Conduct or supervise the investigation personally
◉ Which of the following is an investigator's commitment to the
sponsor?
Answer: Submit a new Form FDA 1572 to the sponsor as needed
, ◉ Informed Consent in Clinical Trials of Drugs, Biologics, and
Devices
Answer:
◉ 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.
◉ Under which circumstance does the FDA allow verbal consent
prior to participation in a research study?
Answer: The study is minimal risk.
◉ 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:
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.
◉ 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
QUESTIONS AND DETAILED SOLUTIONS
◉ When must the investigator update the IRB about the progress of
a trial?
Answer: During the conduct of the study and at termination
◉ Form FDA 1572, Statement of Investigator, is legally binding
between the investigator and the:
Answer: FDA
◉ The investigator must report adverse events to the:
Answer: Sponser
◉ In completing Form FDA 1572, Statement of Investigator, the
investigator agrees to
Answer: Conduct or supervise the investigation personally
◉ Which of the following is an investigator's commitment to the
sponsor?
Answer: Submit a new Form FDA 1572 to the sponsor as needed
, ◉ Informed Consent in Clinical Trials of Drugs, Biologics, and
Devices
Answer:
◉ 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.
◉ Under which circumstance does the FDA allow verbal consent
prior to participation in a research study?
Answer: The study is minimal risk.
◉ 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:
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.
◉ 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
