ACRP-CP EXAM 2025 QUESTIONS AND
ANSWERS
Crossover - ANS when each subject is randomized to a sequence of two or more treatments
and hence acts as their own control for treatment comparisons
Parallel - ANS 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? - ANS Non-
Inferiority
What type of clinical trial most likely requires enrollment of the largest number of research
subjects? - ANS Therapeutic confirmatory (aka Pivotal Trial, Ph III, or Comparative Efficacy)
Minimum number of membors on an IRB/IEC - ANS 5 .. lay people and medical professionals
can be part of the IRB/IEC
Who is responsible for providing the protocol - ANS The Sponsor
The purpose of the SIV is to - ANS -review standard procedures
-review the protocol
1Page
-review the blank eCRFs
@COPYRIGHT FYNDLAY 2025/2026
, Minimum SAE reporting requirements - ANS - 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 - ANS - Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
IRB/IEC Evaluates - ANS - The rights, safety, and well-being of the subjects participating in
the trial
- The subject selection procedure
- The scientific tenability of the trial
Serious Adverse Event (SAE) - ANS - results in death, is life threatening, requires inpatient
admission, prolonged admission, congenital anomaly, or persistent incapacity
-death itself is not neccessarily an sae
- Seriousness does not equal severity in that Serious requires reporting while severe may not..
Severe may just be used to describe an AE
- Must be reported by sponsor to authorities within 15 calendars days from sponsors first
knowledge of the event
2
Page
@COPYRIGHT FYNDLAY 2025/2026
ANSWERS
Crossover - ANS when each subject is randomized to a sequence of two or more treatments
and hence acts as their own control for treatment comparisons
Parallel - ANS 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? - ANS Non-
Inferiority
What type of clinical trial most likely requires enrollment of the largest number of research
subjects? - ANS Therapeutic confirmatory (aka Pivotal Trial, Ph III, or Comparative Efficacy)
Minimum number of membors on an IRB/IEC - ANS 5 .. lay people and medical professionals
can be part of the IRB/IEC
Who is responsible for providing the protocol - ANS The Sponsor
The purpose of the SIV is to - ANS -review standard procedures
-review the protocol
1Page
-review the blank eCRFs
@COPYRIGHT FYNDLAY 2025/2026
, Minimum SAE reporting requirements - ANS - 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 - ANS - Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
IRB/IEC Evaluates - ANS - The rights, safety, and well-being of the subjects participating in
the trial
- The subject selection procedure
- The scientific tenability of the trial
Serious Adverse Event (SAE) - ANS - results in death, is life threatening, requires inpatient
admission, prolonged admission, congenital anomaly, or persistent incapacity
-death itself is not neccessarily an sae
- Seriousness does not equal severity in that Serious requires reporting while severe may not..
Severe may just be used to describe an AE
- Must be reported by sponsor to authorities within 15 calendars days from sponsors first
knowledge of the event
2
Page
@COPYRIGHT FYNDLAY 2025/2026
