CITI Training - Good Clinical Practice correctly answered 2023/2024
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Good Clinical Practice
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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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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