ACRP-CP CERTIFICATION REAL 2024
EXAM QUESTIONS AND VERIFIED
ANSWERS
GAURANTEED SUCCESS
1. What does ICH E11 say about long-term
surveillance of children in clinical trials? -
ANSWERS-
It may be needed to determine the possible
effects on development
2. When each subject is randomized to a
sequence of two or more treatments and hence
acts as their own control for treatment
comparisons - ANSWERS-Crossover
3. When subjects are randomized to 1 of 2 or
more arms: each arm being allocated a different
treatment. Each treatment will include their
1
,investigational product at one or more doses:
and one or more control treatments: such as
placebo and/or an active comparator -
ANSWERS-Parallel
4. 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? - ANSWERS-Non-
Inferiority
5. What type of clinical trial most likely requires
enrollment of the largest number of research
subjects? - ANSWERS-Therapeutic confirmatory
(aka Pivotal Trial: Ph III: or Comparative Efficacy)
2
,6. Minimum number of membors on an
IRB/IEC - ANSWERS-5 (... lay people and
medical professionals can be part of the IRB/IEC)
7. Who is responsible for providing the
protocol - ANSWERS-The Sponsor
8. The purpose of the SIV is to - ANSWERS-1.
review standard procedures
2. review the protocol
3. review the blank eCRFs: Minimum SAE
reporting requirements
4. Subject details (ID not name)
5. IP
6. Interventions for the event that is being
reported
3
, 7. Details of the event
8. Details on the reporter of the event
9. Admin and sponsor or company details
9. Vulnerable subjects - ANSWERS-
1. Junior members of the medical profession
2. Employees of a pharmaceutical company
3. Military personnel
4. Pregnant Women
5. Prisoners
10. IRB/IEC Evaluates - ANSWERS-1. The rights:
safety: and well-being of the subjects
participating in the trial
2. The subject selection procedure
3. The scientific tenability of the trial
4
EXAM QUESTIONS AND VERIFIED
ANSWERS
GAURANTEED SUCCESS
1. What does ICH E11 say about long-term
surveillance of children in clinical trials? -
ANSWERS-
It may be needed to determine the possible
effects on development
2. When each subject is randomized to a
sequence of two or more treatments and hence
acts as their own control for treatment
comparisons - ANSWERS-Crossover
3. When subjects are randomized to 1 of 2 or
more arms: each arm being allocated a different
treatment. Each treatment will include their
1
,investigational product at one or more doses:
and one or more control treatments: such as
placebo and/or an active comparator -
ANSWERS-Parallel
4. 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? - ANSWERS-Non-
Inferiority
5. What type of clinical trial most likely requires
enrollment of the largest number of research
subjects? - ANSWERS-Therapeutic confirmatory
(aka Pivotal Trial: Ph III: or Comparative Efficacy)
2
,6. Minimum number of membors on an
IRB/IEC - ANSWERS-5 (... lay people and
medical professionals can be part of the IRB/IEC)
7. Who is responsible for providing the
protocol - ANSWERS-The Sponsor
8. The purpose of the SIV is to - ANSWERS-1.
review standard procedures
2. review the protocol
3. review the blank eCRFs: Minimum SAE
reporting requirements
4. Subject details (ID not name)
5. IP
6. Interventions for the event that is being
reported
3
, 7. Details of the event
8. Details on the reporter of the event
9. Admin and sponsor or company details
9. Vulnerable subjects - ANSWERS-
1. Junior members of the medical profession
2. Employees of a pharmaceutical company
3. Military personnel
4. Pregnant Women
5. Prisoners
10. IRB/IEC Evaluates - ANSWERS-1. The rights:
safety: and well-being of the subjects
participating in the trial
2. The subject selection procedure
3. The scientific tenability of the trial
4
