1|Page
CITI Training - Good Clinical Practice Newest
2025/2026 Complete All Questions And Correct
Detailed Answers (Verified Answers) |Already Graded
A+||NEWEST EXAM Version!!
Which of the following is an acceptable criterion for
determining that a study of an approved drug does not
require an IND? - ANSWER-The study is not intended to
be reported to FDA to support a new indication or support
a labeling change.
When the sponsor-investigator holds the IND for an
investigational drug he or she is responsible for annual
reporting of which one of the following to FDA? -
ANSWER-IND report
Who is responsible for making the initial risk determination
for a device being used in a study? - ANSWER-The
sponsor-investigator
When must the investigator update the IRB about the
progress of a trial? - ANSWER-During the conduct of the
study and at termination
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.
, 2|Page
Which of the following best describes the principle of
Respect for Persons ad 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 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? - 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
CITI Training - Good Clinical Practice Newest
2025/2026 Complete All Questions And Correct
Detailed Answers (Verified Answers) |Already Graded
A+||NEWEST EXAM Version!!
Which of the following is an acceptable criterion for
determining that a study of an approved drug does not
require an IND? - ANSWER-The study is not intended to
be reported to FDA to support a new indication or support
a labeling change.
When the sponsor-investigator holds the IND for an
investigational drug he or she is responsible for annual
reporting of which one of the following to FDA? -
ANSWER-IND report
Who is responsible for making the initial risk determination
for a device being used in a study? - ANSWER-The
sponsor-investigator
When must the investigator update the IRB about the
progress of a trial? - ANSWER-During the conduct of the
study and at termination
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.
, 2|Page
Which of the following best describes the principle of
Respect for Persons ad 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 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? - 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
