ACRP CP CERTIFICATION EXAM 2024-
2025 ACTUAL EXAM COMPLETE
ACCURATE EXAM QUESTIONS WITH
DETAILED VERIFIED ANSWERS (100%
CORRECT ANSWERS) /ALREADY
GRADED A+
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...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
7. Details of the event
8. Details on the reporter of the event
9. Admin and sponsor or company details
Vulnerable subjects - ....ANSWER...1. Junior
members of the medical profession
2. Employees of a pharmaceutical company
3. Military personnel
,4. Pregnant Women
5. Prisoners
IRB/IEC Evaluates - ....ANSWER...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
Serious Adverse Event (SAE) - ....ANSWER...1.
Results in death: is life threatening
2. Requires inpatient admission
3. Prolonged admission
4. Congenital anomaly
5. Persistent incapacity
6. Death itself is not neccessarily an SAE*
7. Must be reported by sponsor to authorities within
15 calendars days from sponsors first knowledge of
the event
*Seriousness does not equal severity in that Serious
requires reporting while severe may not.. Severe
may just be used to describe an AE
, Adverse Drug Reaction (ADR) - ....ANSWER...1. All
noxious and unintended response that is related to
any dose
2. If the reaction is possibly: probably: or definitely
related to the drug: it is considered an ADR
3. All ADRs must be documented
4. ADRs are not always AEs
Not observed before. Or the Event occurred more
often than previously observed -
....ANSWER...Unexpected Event
Adverse Event (AE) - ....ANSWER...1. Any untoward
medical occurrence that does not necessarily have a
causal relationship with treatment
2. Can be mild moderate or severe
3. Worsening of a pre-existing medical condition is
an AE
Non-Clinical Study - ....ANSWER...1. Not conducted on
human subjects
2. Provide preliminary safety and pharmacokinetic
data needed to support studies in human
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