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ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE
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ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150 QUESTIONS ANCORRECT ANSWERS|AGRADE
Study online at https://quizlet.com/_fvlt5n
1. Crossover when each subject is randomized to a se-
quence of two or more treatments and
hence acts as their own control for treat-
ment 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 ac-
tive 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 con-
dition. 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,
likely requires enrollment of Ph III, or Comparative Efficacy)
the largest number of research
subjects?
5. Minimum number of membors 5 .. lay people and medical professionals
on an IRB/IEC can be part of the IRB/IEC
6. Who is responsible for provid- The Sponsor
ing the protocol
7. The purpose of the SIV is to
, ACRP CP FINAL EXAM LATEST 2024 REAL EXAM 150 QUESTIONS AN
CORRECT ANSWERS|AGRADE
Study online at https://quizlet.com/_fvlt5n
-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 participating in the trial
- The subject selection procedure
- The scientific tenability of the trial
11. Serious Adverse Event (SAE) - results in death, is life threatening, re-
quires inpatient admission, prolonged ad-
mission, congenital anomaly, or persistent
incapacity
-death itself is not neccessarily an sae
- Seriousness does not equal severity in
that Serious requires reporting while se-
vere may not.. Severe may just be used to
describe an AE
- Must be reported by sponsor to authorities
within 15 calendars days from sponsors
first knowledge of the event
12. Adverse Drug Reaction (ADR) - All noxious and unintended response that
is related to any dose
- If the reaction is possibly, probably, or def-
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