ACRP-CP Exam Questions and Correct
Answers
Treatment Emergent - Answer-An event that emerges during treatment having been absent pre-
treatment, or worsens relative to the pre-treatment state.
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
Answers
Treatment Emergent - Answer-An event that emerges during treatment having been absent pre-
treatment, or worsens relative to the pre-treatment state.
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
