100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Previously searched by you
Previously searched by you
logo
CITI Good Clinical Practice Course (US FDA focus) Question and answers correctly solved 2023/2024 $20.99
Add to cart
Quickly navigate to
Preview
  2.  
  3. GOOD CLINICAL PRACTICE
  4.  
  5. GOOD CLINICAL PRACTICE

Exam (elaborations)

CITI Good Clinical Practice Course (US FDA focus) Question and answers correctly solved 2023/2024

1 review
 3 purchases
  • Course
  • GOOD CLINICAL PRACTICE
  • Institution
  • GOOD CLINICAL PRACTICE

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...

[Show more]

Preview 2 out of 7  pages

Document information

  • December 28, 2023
  • 7
  • 2023/2024
  • Exam (elaborations)
  • Questions & answers

Subjects

  • citi good clinical practice course us fda focus
  • citi good clinical practice course us fda focu

Written for

  • GOOD CLINICAL PRACTICE
  • GOOD CLINICAL PRACTICE

1  review

review-writer-avatar

By: robertjames2 • 3 months ago

Seller

avatar-seller
flyhigher329

Reviews received

Content preview

CITI Good Clinical Practice Course (US
FDA focus)

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.

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

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

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

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 flyhigher329. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $20.99. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

69052 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 15 years now

Start selling
$20.99  3x  sold
  • (1)
Add to cart
Added