ACRP CP CERTIFICATION EXAM NEWEST ACTUAL EXAM
COMPLETE 150 QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS)
|ALREADY GRADED A+
Crossover - -----ANSWER---->when each subject is randomized to a sequence of two or more treatments
and hence acts as their own control for treatment comparisons
Parallel - -----ANSWER---->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? - -----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---->-review standard procedures
-review the protocol
-review the blank eCRFs
Minimum SAE reporting requirements - -----ANSWER---->- 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 - -----ANSWER---->- Junior members of the medical profession
- Employees of a pharmaceutical company
- Military personnel
- Pregnant Women
- Prisoners
, IRB/IEC Evaluates - -----ANSWER---->- The rights, safety, and well-being of the subjects participating in the
trial
- The subject selection procedure
- The scientific tenability of the trial
Serious Adverse Event (SAE) - -----ANSWER---->- results in death, is life threatening, requires inpatient
admission, 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 calendars days from sponsors first knowledge of
the event
Adverse Drug Reaction (ADR) - -----ANSWER---->- All noxious and unintended response that is related to
any dose
- If the reaction is possibly, probably, or definitely related to the drug, it is considered an ADR
- All ADRs must be documented
- ADRs are not always AEs
Unexpected Event - -----ANSWER---->Not observed before. Or the
Event occurred more often than previously observed
Adverse Event (AE) - -----ANSWER---->- Any untoward medical occurrence that does not necessarily have
a causal relationship with treatment.
- Can be mild moderate or severe
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