CITI Good Clinical Practice Course (US FDA focus) correctly answered graded A+

CITI Good Clinical Practice Course (US FDA focus) 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. 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 Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans? - correct answer Phase I For a Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure? - correct answer Preclinical data A primary purpose of the ICH is to: - correct answer Minimize the need for redundant research