Exam (elaborations)
GOOD CLINICAL PRACTICE EXAM QUESTIONS AND ANSWERS
- Course
- Institution
GOOD CLINICAL PRACTICE EXAM QUESTIONS AND ANSWERS...
[Show more]
Seller
Follow
Content preview
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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Humat. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $12.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
77858 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now