CRA ACRP COMPREHENSIVE EXAM REVIEW
2026 QUESTIONS WITH EXPLANATIONS AND
FULL CORRECT ANSWERS
◉ Parallel. 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?. Answer: Non-Inferiority
◉ What type of clinical trial most likely requires enrollment of the
largest number of research subjects?. Answer: Therapeutic
confirmatory (aka Pivotal Trial, Ph III, or Comparative Efficacy)
◉ Minimum number of membors on an IRB/IEC. Answer: 5 .. lay
people and medical professionals can be part of the IRB/IEC
, ◉ Who is responsible for providing the protocol. Answer: The
Sponsor
◉ The purpose of the SIV is to. Answer: -review standard
procedures
-review the protocol
-review the blank eCRFs
◉ Minimum SAE reporting requirements. 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. Answer: - Junior members of the medical
profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
2026 QUESTIONS WITH EXPLANATIONS AND
FULL CORRECT ANSWERS
◉ Parallel. 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?. Answer: Non-Inferiority
◉ What type of clinical trial most likely requires enrollment of the
largest number of research subjects?. Answer: Therapeutic
confirmatory (aka Pivotal Trial, Ph III, or Comparative Efficacy)
◉ Minimum number of membors on an IRB/IEC. Answer: 5 .. lay
people and medical professionals can be part of the IRB/IEC
, ◉ Who is responsible for providing the protocol. Answer: The
Sponsor
◉ The purpose of the SIV is to. Answer: -review standard
procedures
-review the protocol
-review the blank eCRFs
◉ Minimum SAE reporting requirements. 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. Answer: - Junior members of the medical
profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
