CITI – GCP QUESTIONS AND ANSWERS 2024/25

CITI – GCP QUESTIONS AND ANSWERS 2024/25 Which of the following best describes the principle of Respect for Persons as described in the Belmont Report? - ANSWER Information, comprehension, voluntariness. Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - ANSWER Determining that the study has maximized benefits and minimized risks. Development of most new drugs, from discovery to marketing approval, usually takes: - ANSWER 9 or more years Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans? - ANSWER Phase I Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development? - ANSWER Preclinical For a Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure? - ANSWER Preclinical data A primary purpose of the ICH is to: - ANSWER Minimize the need for redundant research. The ICH GCP guidelines: - ANSWER Set standards for the design, conduct, monitoring and reporting of clinical research.