ACRP CP COMPREHENSIVE EXAM PAPER WITH
VERIFIED CORRECT SOLUTIONS ELITE REVIEW
2026
◉ 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.
◉ 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.
◉ 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).
◉ 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.
,◉ Tolerability. Answer: Represents the degree to which overt adverse
effects can be tolerated by the subject.
◉ 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.
◉ 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.
◉ Preferred Term. Answer: The level of grouping of included terms
typically used in reporting frequency of occurance.
◉ Included Term. Answer: The lowest level of dictionary term to which
the investigator description is coded.
◉ 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).
,◉ 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.
◉ Meta-Analysis. Answer: A formal evaluation of the quantitative
evidence from two or more trials bearing on the same 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
◉ Intra-rater reliability. Answer: The property of yielding equivalent
results when used by the same rater on different occasions
◉ inter-rater reliability. Answer: The property of yielding equivalent
results when used by different raters on different occasions.
◉ Qualitative interaction. Answer: the direction of the contrast differs
for at least one level of the factor
◉ Quantitative Interaction. Answer: The magnitude of the contrast
differs at the different levels of the factor
, ◉ Intention-To-Treat Principle. Answer: The principle that asserts that
the effect of a treatment policy can be best assessed by evaluating on the
basis of the intention to treat a subject (i.e. the planned treatment
regimen) rather than the actual treatment given. It has the consequence
that subjects allocated to a treatment group should be followed up,
assessed and analysed as members of that group irrespective of their
compliance to the planned course of treatment.
◉ Bayesian Approaches. Answer: Approaches to data analysis that
provide a posterior probability distribution for some parameter (e.g.
treatment effect), derived from the observed data and a prior probability
distribution for the parameter. The posterior distribution is then used as
the basis for statistical inference.
◉ Blind Review. Answer: The checking and assessment of data during
the period of time between trial completion (the last observation on the
last subject) and the breaking of the blind, for the purpose of finalising
the planned analysis.
◉ Content Validity. Answer: The extent to which a variable (e.g. a
rating scale) measures what it is supposed to measure.
◉ Double-Dummy. Answer: A technique for retaining the blind when
administering supplies in a clinical trial, when the two treatments cannot
be made identical. Supplies are prepared for Treatment A (active and
indistinguishable placebo) and for Treatment B (active and
VERIFIED CORRECT SOLUTIONS ELITE REVIEW
2026
◉ 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.
◉ 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.
◉ 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).
◉ 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.
,◉ Tolerability. Answer: Represents the degree to which overt adverse
effects can be tolerated by the subject.
◉ 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.
◉ 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.
◉ Preferred Term. Answer: The level of grouping of included terms
typically used in reporting frequency of occurance.
◉ Included Term. Answer: The lowest level of dictionary term to which
the investigator description is coded.
◉ 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).
,◉ 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.
◉ Meta-Analysis. Answer: A formal evaluation of the quantitative
evidence from two or more trials bearing on the same 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
◉ Intra-rater reliability. Answer: The property of yielding equivalent
results when used by the same rater on different occasions
◉ inter-rater reliability. Answer: The property of yielding equivalent
results when used by different raters on different occasions.
◉ Qualitative interaction. Answer: the direction of the contrast differs
for at least one level of the factor
◉ Quantitative Interaction. Answer: The magnitude of the contrast
differs at the different levels of the factor
, ◉ Intention-To-Treat Principle. Answer: The principle that asserts that
the effect of a treatment policy can be best assessed by evaluating on the
basis of the intention to treat a subject (i.e. the planned treatment
regimen) rather than the actual treatment given. It has the consequence
that subjects allocated to a treatment group should be followed up,
assessed and analysed as members of that group irrespective of their
compliance to the planned course of treatment.
◉ Bayesian Approaches. Answer: Approaches to data analysis that
provide a posterior probability distribution for some parameter (e.g.
treatment effect), derived from the observed data and a prior probability
distribution for the parameter. The posterior distribution is then used as
the basis for statistical inference.
◉ Blind Review. Answer: The checking and assessment of data during
the period of time between trial completion (the last observation on the
last subject) and the breaking of the blind, for the purpose of finalising
the planned analysis.
◉ Content Validity. Answer: The extent to which a variable (e.g. a
rating scale) measures what it is supposed to measure.
◉ Double-Dummy. Answer: A technique for retaining the blind when
administering supplies in a clinical trial, when the two treatments cannot
be made identical. Supplies are prepared for Treatment A (active and
indistinguishable placebo) and for Treatment B (active and
