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ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
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ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
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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
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