CITI – GCP Exam Questions with Correct Answers

Which of the following best describes the principle of Respect for Persons as described in the Belmont Report? Correct 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? Correct Answer Determining that the study has maximized benefits and minimized risks. Development of most new drugs, from discovery to marketing approval, usually takes: Correct 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? Correct Answer Phase I Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development? Correct 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? Correct Answer Preclinical data A primary purpose of the ICH is to: Correct Answer Minimize the need for redundant research. The ICH GCP guidelines: Correct Answer Set standards for the design, conduct, monitoring and reporting of clinical research. ICH E6 describes standards that apply to: Correct Answer Investigators, sponsors, and IRBs In the United States, following the ICH E6 guideline is: Correct Answer Voluntary for FDA-regulated drug studies. In terms of explaining the probability of assignment to trial arms in consent forms, which is true? Correct Answer ICH notes that it should be included, but does not specify how the information should be presented. ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: Correct Answer Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records