CITI Good Clinical Practice Course (US FDA focus) Exam | Verified
Exam Questions and Answers | Latest Updated Study Material 2026
Question:
CITI Good Clinical Practice Course (US FDA focus) Exam
Which of the following are the three principles included in the Belmont Report?
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?
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?
Answer:
Information, comprehension, voluntariness.
Question:
Development of most new drugs, from discovery to marketing approval, usually takes:
Answer:
9 years or more
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?
Answer:
Phase III
, Question:
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug
development?
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?
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?
Answer:
Preclinical data
Question:
A primary purpose of the ICH is to:
Answer:
Minimize the need for
redundant research.
Question:
The ICH GCP guidelines:
Answer:
Set standards for the design, conduct,
monitoring and reporting of clinical research.
Question:
ICH E6 describes standards that apply to:
Answer:
Investigators,
sponsors, and IRBs
Exam Questions and Answers | Latest Updated Study Material 2026
Question:
CITI Good Clinical Practice Course (US FDA focus) Exam
Which of the following are the three principles included in the Belmont Report?
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?
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?
Answer:
Information, comprehension, voluntariness.
Question:
Development of most new drugs, from discovery to marketing approval, usually takes:
Answer:
9 years or more
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?
Answer:
Phase III
, Question:
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug
development?
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?
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?
Answer:
Preclinical data
Question:
A primary purpose of the ICH is to:
Answer:
Minimize the need for
redundant research.
Question:
The ICH GCP guidelines:
Answer:
Set standards for the design, conduct,
monitoring and reporting of clinical research.
Question:
ICH E6 describes standards that apply to:
Answer:
Investigators,
sponsors, and IRBs
