ACRP CP FINAL EXAM AND
PRACTICE EXAM QUESTIONS
2025 ACTUAL EXAM
COMPLETE ACCURATE
EXAM QUESTIONS WITH
DETAILED VERIFIED
ANSWERS (100% CORRECT
ANSWERS)
/ALREADY GRADED A+
,New safety information has become available from the
Sponsor about the IP being used in a clinical trial. The
investigator must: - ....ANSWER...Submit a revised ICF to
the IRB noting the new safety information
Per ICH, an IRB must keep correspondence for at least
how long after the completion of a clinical trial? -
....ANSWER...3 Years
When would an impartial witness be needed during the
consent process for an illiterate subject? -
....ANSWER...To observe the consent process
A study which seeks to determine the ideal dose and
regimen of a new IP to treat hypothyroidism is considered
to be: - ....ANSWER...Phase II
After completion of a study, the final trial close out
monitoring report prepared by the CRA should be filed in
which of the following stakeholder files? -
....ANSWER...The sponsors files
A blood sample collection is required to screen for
bloodborne pathogens before subject could be
,enrolled in a study. Where will subjects find information of
the procedures and any foreseeable risks or
inconveniences? - ....ANSWER...ICF
When should a research study involving human subjects
be registered in a publicly accessible database? -
....ANSWER...Before recruiting the first subject
In the case of an incapacitated subject, who should
receive a copy of the signed and dated ICF? -
....ANSWER...The subjects legally acceptable
representative
A medical student is approaches by a faculty member for
possible participation in a cricothyroidotomy simulation
research study. Which of the following increases risk to
the study? -
....ANSWER...Consenting in the presence of figure of
authority
An event that emerges during treatment having been absent
pre-treatment, or worsens relative to the
pre-treatment state. - ....ANSWER...Treatment Emergent
, An effect attributed to a treatment in a clinical trial. In
most clinical trials the treatment effect of interest is a
comparison (or contrast) of two or more treatments. -
....ANSWER...treatment effect
A variable that provides an indirect measurement of effect
in situations where direct measurement of clinical effect is
not feasible or practical. -
....ANSWER...Surrogate Variable
A trial with the primary objective of showing that the response
to the investigational product is superior to a comparative
agent (active or placebo control). -
....ANSWER...Superiority Trial
Document that contains a more technical and detailed
elaboration of the principal features of the analysis
described in the protocol, and includes detailed
procedures for executing the statistical analysis of the
primary and secondary variables and other data. -
....ANSWER...Statistical Analysis Plan
PRACTICE EXAM QUESTIONS
2025 ACTUAL EXAM
COMPLETE ACCURATE
EXAM QUESTIONS WITH
DETAILED VERIFIED
ANSWERS (100% CORRECT
ANSWERS)
/ALREADY GRADED A+
,New safety information has become available from the
Sponsor about the IP being used in a clinical trial. The
investigator must: - ....ANSWER...Submit a revised ICF to
the IRB noting the new safety information
Per ICH, an IRB must keep correspondence for at least
how long after the completion of a clinical trial? -
....ANSWER...3 Years
When would an impartial witness be needed during the
consent process for an illiterate subject? -
....ANSWER...To observe the consent process
A study which seeks to determine the ideal dose and
regimen of a new IP to treat hypothyroidism is considered
to be: - ....ANSWER...Phase II
After completion of a study, the final trial close out
monitoring report prepared by the CRA should be filed in
which of the following stakeholder files? -
....ANSWER...The sponsors files
A blood sample collection is required to screen for
bloodborne pathogens before subject could be
,enrolled in a study. Where will subjects find information of
the procedures and any foreseeable risks or
inconveniences? - ....ANSWER...ICF
When should a research study involving human subjects
be registered in a publicly accessible database? -
....ANSWER...Before recruiting the first subject
In the case of an incapacitated subject, who should
receive a copy of the signed and dated ICF? -
....ANSWER...The subjects legally acceptable
representative
A medical student is approaches by a faculty member for
possible participation in a cricothyroidotomy simulation
research study. Which of the following increases risk to
the study? -
....ANSWER...Consenting in the presence of figure of
authority
An event that emerges during treatment having been absent
pre-treatment, or worsens relative to the
pre-treatment state. - ....ANSWER...Treatment Emergent
, An effect attributed to a treatment in a clinical trial. In
most clinical trials the treatment effect of interest is a
comparison (or contrast) of two or more treatments. -
....ANSWER...treatment effect
A variable that provides an indirect measurement of effect
in situations where direct measurement of clinical effect is
not feasible or practical. -
....ANSWER...Surrogate Variable
A trial with the primary objective of showing that the response
to the investigational product is superior to a comparative
agent (active or placebo control). -
....ANSWER...Superiority Trial
Document that contains a more technical and detailed
elaboration of the principal features of the analysis
described in the protocol, and includes detailed
procedures for executing the statistical analysis of the
primary and secondary variables and other data. -
....ANSWER...Statistical Analysis Plan
