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CITI Training - Good Clinical Practice correctly answered
Question 1: Which of the following best describes the principle
of Respect for Persons as described in the Belmont Report?
CORRECT ANSWER : Information, comprehension,
voluntariness.
Question 2: 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 3: Development of most new drugs, from discovery to
marketing approval, usually takes:
CORRECT ANSWER : 9 or more years
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Question 4: 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 5: Long-term toxicology of an experimental drug in
animals most likely refers to which part of drug development?
CORRECT ANSWER : Preclinical
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Question 6: 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
Question 7: A primary purpose of the ICH is to:
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CORRECT ANSWER : Minimize the need for redundant
research.
Question 8: The ICH GCP guidelines:
CORRECT ANSWER : Set standards for the design, conduct,
monitoring and reporting of clinical research.
Question 9: ICH E6 describes standards that apply to:
CORRECT ANSWER : Investigators, sponsors, and IRBs
Question 10: In the United States, following the ICH E6
guideline is:
CORRECT ANSWER : Voluntary for FDA-regulated drug
studies.
Question 11: In terms of explaining the probability of
assignment to trial arms in consent forms, which is true?
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CORRECT ANSWER: ICH notes that it should be included, but
does not specify how the information should be presented.
Question 12: 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
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Question 13: What is the status of ICH in U.S.?
CORRECT ANSWER : It is a FDA guidance.
Question 14: The new ICH E6(R2) integrated addendum
requires sponsors to implement systems to manage quality