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GOOD CLINICAL PRACTICE EXAM QUESTIONS AND ANSWERS
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GOOD CLINICAL PRACTICE EXAM QUESTIONS AND ANSWERS...
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Which of the following best sums up the Belmont Report's description of therespect for persons principle?
a) Risk/benefit analysis, research justification, and understanding
b) Risk/benefit ratio, conflicts of interest, and comprehension
c) knowledge, understanding, and voluntariness
d) voluntariness and evaluation of risks and benefits. choice of topics.
ANSWER C
The degree or pace at which a drug or other chemical is absorbed or made
available at the intended location in the body is known as ________________.
The bioavailability of the answer
___________________ denotes that participants are divided into a minimum of
two groups: those who receive the experimental agent and those who receive a
placebo, no therapy, or a standard treatment for the condition (an active
control). The study is a randomized controlled trial if participants are divided
into these groups at random. ANSWER-Controlled
The design, execution, monitoring, auditing, documentation, analysis, and
reporting of clinical trials are all governed by the ______________ standard.
Good Clinical Practice (GCP) is the answer.
__________________ explains how the agent affects the body.
Pharmacodynamics Answer
ANSWER Pharmacogenomics defines ________________ as the application of
genetic data to forecast whether a medication will help a patient get better or get
sick.
,_______________________ explains how the agent enters the body and leaves
it. Pharmacokinetics Answer
Researchers can test the medicine using tissue cultures and animal models in the
first stage of the drug development process. The name of this study is
______________. ANSWER preclinical research
The pre-clinical and clinical data on the investigational product or products that
are pertinent to the research of the product or products in human subjects are
compiled in _________________. - ANSWER The Brochure of the Investigator
(IB)
The definition of a "_____________________" of the original record is
likewise provided in ICH E6. A physical or electronic copy of the original
document must have been validated (for instance, by a dated signature) or
created via a validated method to create a replica of the original for it to be
(this). A Certified Copy of the Answer
Which of the following best describes the first Investigator's Brochure (IB) for a
proposed clinical study of a novel drug?
Preclinical studies
b) Phase II research. Preclinical trials for ANSWER
From discovery to marketing approval, the majority of new drug development
typically takes:
A) Five years
, B) Under five months
C) One to three years
D) At least nine years - ANSWER D
In a double-blind research, adults who had experienced migraines for more than
twelve (12) months were randomized to receive therapy with either a placebo or
the investigational medication X (10 or 20 mg/day). The decrease in migraine
attack intensity was the main indicator of efficacy. Twelve hundred (1200)
subjects were enrolled. Which of the following best sums up this study's clinical
phase?
A) Phase II
B) Phase III
C) Preclinical
D) Phase I: ANSWER B
Which stage of drug development is most likely involved in the long-term
toxicity of an investigational medication in animals?
A) Phase II
B) Preclinical
C) First Phase
D) Phase Three: ANSWER B
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