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CITI Training - Good Clinical Practice correctly answered 2023/2024
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CITI Training - Good Clinical Practice Good Clinical Practice Course for Clinical Trials with Investigational Drugs and Medical Devices - correct answer Which of the following are the three principles included in the Belmont Report? - correct answer Respect for Persons, Beneficence, Justice. ...

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  • January 15, 2024
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  • 2023/2024
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CITI Training - Good Clinical Practice

Good Clinical Practice Course for Clinical Trials with Investigational Drugs and Medical Devices - correct
answer



Which of the following are the three principles included in the Belmont Report? - correct answer Respect
for Persons, Beneficence, Justice.



Which of the following is an example of how the Principle of Beneficence can be applied to a study
employing human subjects? - correct answer Determining that the study has maximized benefits and
minimized risks.



Which of the following best describes the principle of Respect for Persons as described in the Belmont
Report? - correct answer Information, comprehension, voluntariness.



Investigator Obligations in FDA-Regulated Research - correct answer



When must the investigator update the IRB about the progress of a trial? - correct answer During the
conduct of the study and at termination



Form FDA 1572, Statement of Investigator, is legally binding between the investigator and the: - correct
answer FDA



The investigator must report adverse events to the: - correct answer Sponser



In completing Form FDA 1572, Statement of Investigator, the investigator agrees to - correct answer
Conduct or supervise the investigation personally



Which of the following is an investigator's commitment to the sponsor? - correct answer Submit a new
Form FDA 1572 to the sponsor as needed

, Informed Consent in Clinical Trials of Drugs, Biologics, and Devices - correct answer



Which of the following statements in a consent form is an example of exculpatory language? - correct
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? -
correct 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: - correct 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 new drug becomes commercially available that may have equal or greater
benefit to the subject. The investigator should do which of the following? - correct 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.



Overview of New Drug Development - correct answer



Development of most new drugs, from discovery to marketing approval, usually takes: - correct answer 9
years or more



Adults with more than a twelve (12)-month history of migraines were assigned randomly in a double-
blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary
efficacy measure was the reduction in severity of the migraine attacks. Enrollment was twelve-hundred
(1200) subjects. Which of the following best describes the clinical phase of this study? - correct answer
Phase III



Long-term toxicology of an experimental drug in animals most likely refers to which part of drug
development? - correct answer Preclinical

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