GOOD CLINICAL PRACTICE FINAL STUDY
GUIDE 2026 TESTED ITEMS SOLVED
◉ Determining that the study has maximized benefits and
minimized risks. Answer: Which of the following is an example of
how the Principle of Beneficence can be applied to a study
employing human subjects?
◉ Information, comprehension, voluntariness. Answer: Which of the
following best describes the principle of Respect for Persons ad
described in the Belmont Report
◉ 9 years or more Answer: Development of most new drugs from
discovery to marketing approval usually takes:
◉ Phase III Answer: Adults with more than a 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 1200 subjects. Which of the
following best describes the clinical phase of this study?
◉ Preclinical Answer: Long-term toxicology of an experimental drug
in animals most likely refers to which part of drug development?
, ◉ Phase I Answer: Pharmacokinetics and pharmacodynamics of a
new formulation of an investigational drug most likely refers to
which clinical phase of a study in humans?
◉ Preclinical data Answer: For a phase I new drug study in humans,
what is the primary source of the data included in the initial
Investigator's Brochure?
◉ Minimize the need for redundant research Answer: A primary
purpose of the ICH is to:
◉ Set standards for the design, conduct, monitoring and reporting of
clinical research. Answer: The ICH GCP Guidelines:
◉ Investigators, sponsors, and IRBs. Answer: The ICH E6 GCP
describes standards that apply to:
◉ Voluntary for FDA-regulated drug studies. Answer: In the United
States, following the ICH E6 GCP is:
◉ ICH notes that it should be included, but does not specify how the
information should be presented. Answer: In terms of explaining the
probability of assignment to trial arms in consent forms, which is
true?
GUIDE 2026 TESTED ITEMS SOLVED
◉ Determining that the study has maximized benefits and
minimized risks. Answer: Which of the following is an example of
how the Principle of Beneficence can be applied to a study
employing human subjects?
◉ Information, comprehension, voluntariness. Answer: Which of the
following best describes the principle of Respect for Persons ad
described in the Belmont Report
◉ 9 years or more Answer: Development of most new drugs from
discovery to marketing approval usually takes:
◉ Phase III Answer: Adults with more than a 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 1200 subjects. Which of the
following best describes the clinical phase of this study?
◉ Preclinical Answer: Long-term toxicology of an experimental drug
in animals most likely refers to which part of drug development?
, ◉ Phase I Answer: Pharmacokinetics and pharmacodynamics of a
new formulation of an investigational drug most likely refers to
which clinical phase of a study in humans?
◉ Preclinical data Answer: For a phase I new drug study in humans,
what is the primary source of the data included in the initial
Investigator's Brochure?
◉ Minimize the need for redundant research Answer: A primary
purpose of the ICH is to:
◉ Set standards for the design, conduct, monitoring and reporting of
clinical research. Answer: The ICH GCP Guidelines:
◉ Investigators, sponsors, and IRBs. Answer: The ICH E6 GCP
describes standards that apply to:
◉ Voluntary for FDA-regulated drug studies. Answer: In the United
States, following the ICH E6 GCP is:
◉ ICH notes that it should be included, but does not specify how the
information should be presented. Answer: In terms of explaining the
probability of assignment to trial arms in consent forms, which is
true?
