ACRP CP Verified Exam Questions and Answers Latest update
2026/2027
Question:
and
Answer:
Question:
Treatment Emergent
Answer:
An event that emerges during treatment having been absent pre-treatment, or worsens relative to the
pre-treatment state.
Question:
treatment effect
Answer:
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.
Question:
Surrogate Variable
Answer:
A variable that provides an indirect measurement of effect in situations where direct measurement of
clinical effect is not feasible or practical.
Question:
Superiority Trial
Answer:
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).
Question:
Statistical Analysis Plan
Answer:
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.
,Question:
Tolerability
Answer:
Represents the degree to which overt adverse effects can be tolerated by the subject.
Question:
Product Safety
Answer:
The medical risks to a subject, usually assessed in a clinical trial by laboratory tests, vital signs,
clinical adverse events, and other safety tests.
Question:
Per Protocol Set
Answer:
A set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure
that these data would be likely to exhibit the effects of treatment, according to the underlying scientific
model. Compliance covers such considerations as exposure to treatment, availability of measurements,
and absence of major protocol deviations.
Question:
Preferred Term
Answer:
The level of grouping of included terms typically used in reporting frequency of occurance.
Question:
Included Term
Answer:
The lowest level of dictionary term to which the investigator description is coded.
Question:
Non-inferiority Trial
Answer:
A trial with the primary objective of showing that the response to the investigational product is not
clinically inferior to a comparative agent (active or placebo control).
, Question:
Multicenter Trial
Answer:
A clinical trial conducted according to a single protocol but at more than one site, and therefore,
carried out by more than one investigator.
Question:
Meta-Analysis
Answer:
A formal evaluation of the quantitative evidence from two or more trials bearing on the same question
Question:
Interim Analysis
Answer:
any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to
the formal completion of a trial
Question:
Intra-rater reliability
Answer:
The property of yielding equivalent results when used by the same rater on different occasions
Question:
inter-rater reliability
Answer:
The property of yielding equivalent results when used by different raters on different occasions.
Question:
Qualitative interaction
Answer:
the direction of the contrast differs for at least one level of the factor
Question:
Quantitative Interaction
Answer:
The magnitude of the contrast differs at the different levels of the factor
2026/2027
Question:
and
Answer:
Question:
Treatment Emergent
Answer:
An event that emerges during treatment having been absent pre-treatment, or worsens relative to the
pre-treatment state.
Question:
treatment effect
Answer:
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.
Question:
Surrogate Variable
Answer:
A variable that provides an indirect measurement of effect in situations where direct measurement of
clinical effect is not feasible or practical.
Question:
Superiority Trial
Answer:
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).
Question:
Statistical Analysis Plan
Answer:
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.
,Question:
Tolerability
Answer:
Represents the degree to which overt adverse effects can be tolerated by the subject.
Question:
Product Safety
Answer:
The medical risks to a subject, usually assessed in a clinical trial by laboratory tests, vital signs,
clinical adverse events, and other safety tests.
Question:
Per Protocol Set
Answer:
A set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure
that these data would be likely to exhibit the effects of treatment, according to the underlying scientific
model. Compliance covers such considerations as exposure to treatment, availability of measurements,
and absence of major protocol deviations.
Question:
Preferred Term
Answer:
The level of grouping of included terms typically used in reporting frequency of occurance.
Question:
Included Term
Answer:
The lowest level of dictionary term to which the investigator description is coded.
Question:
Non-inferiority Trial
Answer:
A trial with the primary objective of showing that the response to the investigational product is not
clinically inferior to a comparative agent (active or placebo control).
, Question:
Multicenter Trial
Answer:
A clinical trial conducted according to a single protocol but at more than one site, and therefore,
carried out by more than one investigator.
Question:
Meta-Analysis
Answer:
A formal evaluation of the quantitative evidence from two or more trials bearing on the same question
Question:
Interim Analysis
Answer:
any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to
the formal completion of a trial
Question:
Intra-rater reliability
Answer:
The property of yielding equivalent results when used by the same rater on different occasions
Question:
inter-rater reliability
Answer:
The property of yielding equivalent results when used by different raters on different occasions.
Question:
Qualitative interaction
Answer:
the direction of the contrast differs for at least one level of the factor
Question:
Quantitative Interaction
Answer:
The magnitude of the contrast differs at the different levels of the factor
