ACRP CP FINAL EXAM QUESTIONS WITH
COMPLETE SOLUTIONS GUARANTEED PASS BRAND
NEW 2026
Crossover - 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 - 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
pg. 1
, 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
IRB/IEC Evaluates - ANSWER..> - The rights, safety, and wellbeing of the
subjects participating in the trial - The subject selection procedure
- The scientific tenability of the trial
Serious Adverse Event (SAE) - ANSWER..> - results in death, is life threatening,
requires inpatient admission, prolonged admission, congenital anomaly, or
persistent incapacity
pg. 2
COMPLETE SOLUTIONS GUARANTEED PASS BRAND
NEW 2026
Crossover - 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 - 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
pg. 1
, 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
IRB/IEC Evaluates - ANSWER..> - The rights, safety, and wellbeing of the
subjects participating in the trial - The subject selection procedure
- The scientific tenability of the trial
Serious Adverse Event (SAE) - ANSWER..> - results in death, is life threatening,
requires inpatient admission, prolonged admission, congenital anomaly, or
persistent incapacity
pg. 2
