Exam (elaborations)
ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
- Course
- Institution
ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
[Show more]
Seller
Follow
Content preview
10/21/24, 8:01 AM ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE Flashcards | QuizletACRP CP FINAL EXAM LATEST 2024 REAL EXAM
150 QUESTIONS AND CORRECT
ANSWERS|AGRADE
Terms in this set (79)
when each subject is randomized to a sequence of
Crossover two or more treatments and hence acts as their own
control for treatment comparisons
when subjects are randomized to 1 of 2 or more arms,
each arm being allocated a different treatment. Each
treatment will include their investigational product at
Parallel
one or more doses, and one or more control
treatments, such as placebo and/or an active
comparator
A sponsor is developing Non-Inferiority
an IP for treatment of a
medical condition where
there is one additional
marketed product
approved for treatment of
the condition. The sponsor
believes their product
works as well or better
than the current treatment
with fewer side effects.
What is the most-likely
study design they will use
to test the efficacy of the
IP?
https://quizlet.com/960078299/acrp-cp-final-exam-latest-2024-real-exam-150-questions-and-correct-answersagrade-flash-cards/?new 1/11
, 10/21/24, 8:01 AM ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE Flashcards | Quizlet
What type of clinical trial Therapeutic confirmatory (aka Pivotal Trial, Ph III, or
most likely requires Comparative Efficacy)
enrollment of the largest
number of research
subjects?
Minimum number of 5 .. lay people and medical professionals can be part
membors on an IRB/IEC of the IRB/IEC
Who is responsible for The Sponsor
providing the protocol
-review standard procedures
The purpose of the SIV is
-review the protocol
to
-review the blank eCRFs
- Subject details (ID not name)
- IP
Minimum SAE reporting - Interventions for the event that is being reported
requirements - Details of the event
- Details on the reporter of the event
- Admin and sponsor or company details/
- Junior members of the medical profession
- Employees of a pharmaceutical company
Vulnerable subjects - Military personnel
- Pregnant Women
- Prisoners
- The rights, safety, and well-being of the subjects
participating in the trial
IRB/IEC Evaluates
- The subject selection procedure
- The scientific tenability of the trial
https://quizlet.com/960078299/acrp-cp-final-exam-latest-2024-real-exam-150-questions-and-correct-answersagrade-flash-cards/?new 2/11
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 Eurominds. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $0.00. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
81633 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now