Good Clinical Practice (GCP) with answers rated A+ 2023/2024

Good Clinical Practice (GCP)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 ad 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 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 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