ACRP CP FINAL EXAM QUESTIONS WITH COMPLETE SOLUTIONS
GUARANTEED PASS BRAND NEW 2025
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
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
GUARANTEED PASS BRAND NEW 2025
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
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
