ACRP CP FINAL EXAM QUESTIONS AND
ANSWERS 2025
Crossover - correct answer- when each subject is randomized to a sequence
of two or more treatments and hence acts as their own control for treatment
comparisons
Parallel - correct answer- 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 one or more doses, and one or more
control treatments, such as placebo and/or an active comparator
A sponsor is developing 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? - correct answer-
Non-Inferiority
What type of clinical trial most likely requires enrollment of the largest
number of research subjects? - correct answer- Therapeutic confirmatory
(aka Pivotal Trial, Ph III, or Comparative Efficacy)
Minimum number of membors on an IRB/IEC - correct answer- 5 .. lay
people and medical professionals can be part of the
IRB/IEC
, Who is responsible for providing the protocol - correct answer- The
Sponsor
The purpose of the SIV is to - correct answer- -review standard procedures
-review the protocol
-review the blank eCRFs
Minimum SAE reporting requirements - correct answer- - Subject details
(ID not name)
- IP
- Interventions for the event that is being reported
- Details of the event
- Details on the reporter of the event
- Admin and sponsor or company details/
Vulnerable subjects - correct answer- - Junior members of the medical
profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
IRB/IEC Evaluates - correct answer- - The rights, safety, and well-being
of the subjects participating in the trial
ANSWERS 2025
Crossover - correct answer- when each subject is randomized to a sequence
of two or more treatments and hence acts as their own control for treatment
comparisons
Parallel - correct answer- 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 one or more doses, and one or more
control treatments, such as placebo and/or an active comparator
A sponsor is developing 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? - correct answer-
Non-Inferiority
What type of clinical trial most likely requires enrollment of the largest
number of research subjects? - correct answer- Therapeutic confirmatory
(aka Pivotal Trial, Ph III, or Comparative Efficacy)
Minimum number of membors on an IRB/IEC - correct answer- 5 .. lay
people and medical professionals can be part of the
IRB/IEC
, Who is responsible for providing the protocol - correct answer- The
Sponsor
The purpose of the SIV is to - correct answer- -review standard procedures
-review the protocol
-review the blank eCRFs
Minimum SAE reporting requirements - correct answer- - Subject details
(ID not name)
- IP
- Interventions for the event that is being reported
- Details of the event
- Details on the reporter of the event
- Admin and sponsor or company details/
Vulnerable subjects - correct answer- - Junior members of the medical
profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
IRB/IEC Evaluates - correct answer- - The rights, safety, and well-being
of the subjects participating in the trial
