CITI Good Clinical Practice Course (US FDA focus) Question and answers correctly solved 2023/2024Which of the following are the three principles included in the Belmont Report? - correct answer Respect for Persons, Beneficence, Justice.
Which of the following is an example of how the Principle o...
Which of the following are the three principles included in the Belmont Report? - correct answer Respect
for Persons, Beneficence, Justice.
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.
Which of the following best describes the principle of Respect for Persons as described in the Belmont
Report? - correct answer Information, comprehension, voluntariness.
Development of most new drugs, from discovery to marketing approval, usually takes: - correct 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? - correct answer
Phase III
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug
development? - correct 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? - correct 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? - correct answer Preclinical data
A primary purpose of the ICH is to: - correct answer Minimize the need for redundant research.
, The ICH GCP guidelines: - correct answer Set standards for the design, conduct, monitoring and reporting
of clinical research.
ICH E6 describes standards that apply to: - correct answer Investigators, sponsors, and IRBs
In the United States, following the ICH E6 guideline is: - correct answer Voluntary for FDA-regulated drug
studies.
The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality
throughout all stages of the trial process. The system should use a risk-based approach including which
of the following? - correct answer Identification of study risks to determine which may safely be omitted
from continual monitoring.
What is the status of ICH in U.S.? - correct answer It is a FDA guidance.
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
In terms of explaining the probability of assignment to trial arms in consent forms, which is true? -
correct answer ICH notes that it should be included, but does not specify how the information should be
presented.
Regarding subject receipt of a signed and dated copy of the consent forms, which is true about FDA
regulations? - correct answer The FDA regulations allow subjects or the legally acceptable
representatives (LARs) to receive either a signed or unsigned copy.
Who is responsible for making the initial risk determination for a device being used in a study? - correct
answer The sponsor-investigator.
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