ACRP CP Study Guide Questions with Verified
Correct Answers
Treatment Emergent
An event that emerges during treatment having been absent pre-treatment, or worsens relative
to the pre-treatment state.
treatment effect
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
A variable that provides an indirect measurement of effect in situations where direct
measurement of clinical effect is not feasible or practical.
Superiority Trial
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
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
Represents the degree to which overt adverse effects can be tolerated by the subject.
Product Safety
,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
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
The level of grouping of included terms typically used in reporting frequency of occurance.
Included Term
The lowest level of dictionary term to which the investigator description is coded.
Non-inferiority Trial
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
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
A formal evaluation of the quantitative evidence from two or more trials bearing on the same
question
Interim Analysis
, 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
The property of yielding equivalent results when used by the same rater on different
occasions
inter-rater reliability
The property of yielding equivalent results when used by different raters on different
occasions.
Qualitative interaction
the direction of the contrast differs for at least one level of the factor
Quantitative Interaction
The magnitude of the contrast differs at the different levels of the factor
Intention-To-Treat Principle
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
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
Correct Answers
Treatment Emergent
An event that emerges during treatment having been absent pre-treatment, or worsens relative
to the pre-treatment state.
treatment effect
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
A variable that provides an indirect measurement of effect in situations where direct
measurement of clinical effect is not feasible or practical.
Superiority Trial
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
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
Represents the degree to which overt adverse effects can be tolerated by the subject.
Product Safety
,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
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
The level of grouping of included terms typically used in reporting frequency of occurance.
Included Term
The lowest level of dictionary term to which the investigator description is coded.
Non-inferiority Trial
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
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
A formal evaluation of the quantitative evidence from two or more trials bearing on the same
question
Interim Analysis
, 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
The property of yielding equivalent results when used by the same rater on different
occasions
inter-rater reliability
The property of yielding equivalent results when used by different raters on different
occasions.
Qualitative interaction
the direction of the contrast differs for at least one level of the factor
Quantitative Interaction
The magnitude of the contrast differs at the different levels of the factor
Intention-To-Treat Principle
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
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
