Exam (elaborations)
GOOD CLINICAL PRACTICE (GCP) EXAM QUESTIONS AND ANSWERS
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GOOD CLINICAL PRACTICE (GCP) EXAM QUESTIONS AND ANSWERS...
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Which of the three concepts outlined in the Belmont Report? - ANSWER:Respect for people, beneficence, justice.
Which of the following is an example of how to apply the Principle of
Beneficence to a study involving human participants? - ANSWER determining
that the trial has maximized benefits while minimizing risks.
Which of the following best illustrates the principle of respect for persons as
articulated in the Belmont Report?
Most new medications require at least 9 years from discovery to commercial
approval.
In a double-blind research, adults with a migraine history of more than 12
months were randomly assigned to receive therapy with the investigational
medication X (10 or 20 mg/day) or a placebo. The major efficacy metric was
the reduction in the severity of migraine attacks. A total of 1200 subjects were
enrolled. Which of the following best defines the clinical stage of this study? -
Answer Phase III
Long-term toxicity of an experimental medicine in animals is most usually
related to which stage of drug development? - ANSWER Preclinical
The pharmacokinetics and pharmacodynamics of a new formulation of an
experimental medicine are most typically associated with which clinical phase
of a human study? - Phase I ANSWER.
, What is the primary source of data in the initial Investigator's Brochure for a
phase I human drug study? - ANSWER Preclinical results
The ICH's principal objective is to: Reduce the need for unnecessary research.
The ICH GCP Guidelines: ANSWER Establish guidelines for the design,
conduct, monitoring, and reporting of clinical research.
The ICH E6 GCP specifies criteria for: ANSWER Investigators, sponsors, and
IRBs.
In the United States, compliance with the ICH E6 GCP is voluntary for FDA-
regulated drug research.
Which is correct when stating the probability of assignment to trial arms in
consent forms? - ANSWER ICH acknowledges that it should be included but
does not specify how the data should be presented.
Which FDA requirements apply to the subject's receipt of a signed and dated
copy of the consent forms? - ANSWER The FDA regulations permit subjects or
legally acceptable representatives (LARs) to receive a signed or unsigned copy.
The new ICH E6 integrated addendum (R2) requires sponsors to incorporate
quality management systems at all phases of the trial procedure. The system
should take a risk-based strategy that includes which of the following? -
ANSWER Identifying research risks to evaluate which can be safely excluded
from continuous monitoring.
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