CITI TRAINING GOOD CLINICAL PRACTICE
COMPLETE COURSE REVIEW GUIDE
◉ 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.
◉ Which of the following best describes the principle of Respect for
Persons as described in the Belmont Report?
Answer: Information, comprehension, voluntariness.
◉ Development of most new drugs, from discovery to marketing
approval, usually takes:
Answer: 9 years or more
◉ 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?
Answer: Phase III
, ◉ Long-term toxicology of an experimental drug in animals most
likely refers to which part of drug development?
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?
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?
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.
◉ ICH E6 describes standards that apply to:
Answer: Investigators, sponsors, and IRBs
COMPLETE COURSE REVIEW GUIDE
◉ 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.
◉ Which of the following best describes the principle of Respect for
Persons as described in the Belmont Report?
Answer: Information, comprehension, voluntariness.
◉ Development of most new drugs, from discovery to marketing
approval, usually takes:
Answer: 9 years or more
◉ 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?
Answer: Phase III
, ◉ Long-term toxicology of an experimental drug in animals most
likely refers to which part of drug development?
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?
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?
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.
◉ ICH E6 describes standards that apply to:
Answer: Investigators, sponsors, and IRBs
