ACRP CP EXAM NEWEST ACTUAL EXAM
COMPLETE 100 QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS)
|ALREADY GRADED A+
ACRP CP EXAM
A site is in the start-up phase of an industry-
sponsored phase 3 trial, and has received
IRB/IEC approval. When can the site begin
enrolling subjects? - ✔✔ANSW✔✔..after a
signed clinical trial agreement between the
site and sponsor is in place
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? -
✔✔ANSW✔✔..Non-Inferiority
,Adverse Drug Reaction (ADR) - ✔✔ANSW✔✔..-
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
Adverse Event (AE) - ✔✔ANSW✔✔..- Any
untoward medical occurrence that does not
necessarily have a causal relationship with
treatment.
- Can be mild moderate or severe
- Worsening of a pre-existing medical condition
is an AE
After completion of a study, where should the
final trial close-out monitoring report prepared
by the CRAbe filed - ✔✔ANSW✔✔..in the
Sponsor's files
All SAE's must be life-threatening to be
considered an SAE opposed to AE (T/F) -
✔✔ANSW✔✔..True
, All SAE's must be life-threatening to be
considered an SAE opposed to AE (T/F) -
✔✔ANSW✔✔..True
All trial phases assess safety (T/F) -
✔✔ANSW✔✔..True
Any changes to an IB are not required to be
submitted to the IRB/IEC (T/F) -
✔✔ANSW✔✔..False. changes to safety language
must be submitted to the IRB
Any changes to safety language in an IB should
be submitted to the IRB/IEC (T/F) -
✔✔ANSW✔✔..True
Centralized monitoring supports clinical data
review by examining data trends (T/F) -
✔✔ANSW✔✔..True
Confidence Interval - ✔✔ANSW✔✔..The degree
of certainty in the sampling method. The wider
the CI, the more data variability
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