ACRP-CP Exam
Study online at https://quizlet.com/_h67mn4
1. Crossover when each subject is randomized to a sequence of two or
more treatments and hence acts as their own control for
treatment comparisons
2. Parallel 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
3. A sponsor is developing an IP Non-Inferiority
for treatment of a medical con-
dition where there is one ad-
ditional marketed product ap-
proved for treatment of the
condition. The sponsor believes
their product works as well or
better than the current treat-
ment with fewer side effects.
What is the most-likely study
design they will use to test the
efficacy of the IP?
4. What type of clinical trial most Therapeutic confirmatory (aka Pivotal Trial, Ph III, or Compar-
likely requires enrollment of ative Efficacy)
the largest number of research
subjects?
5. Minimum number of membors 5 .. lay people and medical professionals can be part of the
on an IRB/IEC IRB/IEC
6. Who is responsible for provid- The Sponsor
ing the protocol
, ACRP-CP Exam
Study online at https://quizlet.com/_h67mn4
7. The purpose of the SIV is to -review standard procedures
-review the protocol
-review the blank eCRFs
8. Minimum SAE reporting re- - Subject details (ID not name)
quirements - 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/
9. Vulnerable subjects - Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
10. IRB/IEC Evaluates - The rights, safety, and well-being of the subjects participat-
ing in the trial
- The subject selection procedure
- The scientific tenability of the trial
11. Serious Adverse Event (SAE) - results in death, is life threatening, requires inpatient admis-
sion, 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 cal-
endars days from sponsors first knowledge of the event
Study online at https://quizlet.com/_h67mn4
1. Crossover when each subject is randomized to a sequence of two or
more treatments and hence acts as their own control for
treatment comparisons
2. Parallel 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
3. A sponsor is developing an IP Non-Inferiority
for treatment of a medical con-
dition where there is one ad-
ditional marketed product ap-
proved for treatment of the
condition. The sponsor believes
their product works as well or
better than the current treat-
ment with fewer side effects.
What is the most-likely study
design they will use to test the
efficacy of the IP?
4. What type of clinical trial most Therapeutic confirmatory (aka Pivotal Trial, Ph III, or Compar-
likely requires enrollment of ative Efficacy)
the largest number of research
subjects?
5. Minimum number of membors 5 .. lay people and medical professionals can be part of the
on an IRB/IEC IRB/IEC
6. Who is responsible for provid- The Sponsor
ing the protocol
, ACRP-CP Exam
Study online at https://quizlet.com/_h67mn4
7. The purpose of the SIV is to -review standard procedures
-review the protocol
-review the blank eCRFs
8. Minimum SAE reporting re- - Subject details (ID not name)
quirements - 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/
9. Vulnerable subjects - Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
10. IRB/IEC Evaluates - The rights, safety, and well-being of the subjects participat-
ing in the trial
- The subject selection procedure
- The scientific tenability of the trial
11. Serious Adverse Event (SAE) - results in death, is life threatening, requires inpatient admis-
sion, 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 cal-
endars days from sponsors first knowledge of the event
