6/27/25, 8:30 AM ACRP Practice Exam LATEST (2025) COMPLETE QUESTIONS With 100% Verified Solutions, Flashcards | Quizlet
ACRP Practice Exam LATEST (2025) COMPLETE
QUESTIONS With 100% Verified Solutions,
Save
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
https://quizlet.com/1057224052/acrp-practice-exam-latest-2025-complete-questions-with-100-verified-solutions-flash-cards/?new 1/11
, 6/27/25, 8:30 AM ACRP Practice Exam LATEST (2025) COMPLETE QUESTIONS With 100% Verified Solutions, Flashcards | Quizlet
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?
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/
https://quizlet.com/1057224052/acrp-practice-exam-latest-2025-complete-questions-with-100-verified-solutions-flash-cards/?new 2/11
ACRP Practice Exam LATEST (2025) COMPLETE
QUESTIONS With 100% Verified Solutions,
Save
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
https://quizlet.com/1057224052/acrp-practice-exam-latest-2025-complete-questions-with-100-verified-solutions-flash-cards/?new 1/11
, 6/27/25, 8:30 AM ACRP Practice Exam LATEST (2025) COMPLETE QUESTIONS With 100% Verified Solutions, Flashcards | Quizlet
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?
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/
https://quizlet.com/1057224052/acrp-practice-exam-latest-2025-complete-questions-with-100-verified-solutions-flash-cards/?new 2/11
