ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150
QUESTIONS | TESTED AND PROVEN ANSWERS |
LATEST UPDATE 2024/2025 100% (GRADE A+)
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
1
,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
-review the blank eCRFs
Minimum SAE reporting requirements
2
, 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
3
QUESTIONS | TESTED AND PROVEN ANSWERS |
LATEST UPDATE 2024/2025 100% (GRADE A+)
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
1
,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
-review the blank eCRFs
Minimum SAE reporting requirements
2
, 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
3
