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CITI GOOD CLINICAL PRACTICE COURSE
(US FDA FOCUS) QUESTION AND ANSWERS
CORRECTLY SOLVED
Question : Which of the following are the three principles
included in the Belmont Report?
Correct answer: Respect for Persons, Beneficence, Justice.
Question : 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.
Question : Which of the following best describes the principle of
Respect for Persons as described in the Belmont Report?
Correct answer: Information, comprehension, voluntariness.
Question : Development of most new drugs, from discovery to
marketing approval, usually takes:
Correct answer: 9 years or more
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Question : 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
Question : Long-term toxicology of an experimental drug in
animals most likely refers to which part of drug development?
Correct answer: Preclinical
Question : 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
Question : 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
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Question : A primary purpose of the ICH is to:
Correct answer: Minimize the need for redundant research.
Question : The ICH GCP guidelines:
Correct answer: Set standards for the design, conduct,
monitoring and reporting of clinical research.
Question : ICH E6 describes standards that apply to:
Correct answer: Investigators, sponsors, and IRBs
Question : In the United States, following the ICH E6 guideline
is:
Correct answer: Voluntary for FDA-regulated drug studies.
Question : The new ICH E6(R2) integrated addendum requires
sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following?
Correct answer: Identification of study risks to determine which
may safely be omitted from continual monitoring.
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Question : What is the status of ICH in U.S.?
Correct answer: It is a FDA guidance.
Question : 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
Question : 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.
Question : Regarding subject receipt of a signed and dated copy
of the consent forms, which is true about FDA regulations?