ACRP CP UPDATED ACTUAL Questions
and CORRECT Answers
Treatment Emergent - CORRECT ANSWERS An event that emerges during treatment
having been absent pre-treatment, or worsens relative to the pre-treatment state.
treatment effect - CORRECT ANSWERS 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 - CORRECT ANSWERS A variable that provides an indirect
measurement of effect in situations where direct measurement of clinical effect is not feasible or
practical.
Superiority Trial - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS Represents the degree to which overt adverse effects
can be tolerated by the subject.
Product Safety - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS The level of grouping of included terms typically
used in reporting frequency of occurance.
Included Term - CORRECT ANSWERS The lowest level of dictionary term to which the
investigator description is coded.
Non-inferiority Trial - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS A formal evaluation of the quantitative evidence
from two or more trials bearing on the same question
Interim Analysis - CORRECT ANSWERS 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 - CORRECT ANSWERS The property of yielding equivalent results
when used by the same rater on different occasions
inter-rater reliability - CORRECT ANSWERS The property of yielding equivalent results
when used by different raters on different occasions.
Qualitative interaction - CORRECT ANSWERS the direction of the contrast differs for at
least one level of the factor
, Quantitative Interaction - CORRECT ANSWERS The magnitude of the contrast differs at
the different levels of the factor
Intention-To-Treat Principle - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS The extent to which a variable (e.g. a rating
scale) measures what it is supposed to measure.
Double-Dummy - CORRECT ANSWERS 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 indistinguishable placebo). Subjects then take two sets of treatment; either A
(active) and B (placebo), or A (placebo) and B (active).
Dropout - CORRECT ANSWERS A subject in a clinical trial who for any reason fails to
continue in the trial until the last visit required of him/her by the study protocol.
Equivalence Trial - CORRECT ANSWERS A trial with the primary objective of showing
that the response to two or more treatments differs by an amount which is clinically unimportant.
and CORRECT Answers
Treatment Emergent - CORRECT ANSWERS An event that emerges during treatment
having been absent pre-treatment, or worsens relative to the pre-treatment state.
treatment effect - CORRECT ANSWERS 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 - CORRECT ANSWERS A variable that provides an indirect
measurement of effect in situations where direct measurement of clinical effect is not feasible or
practical.
Superiority Trial - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS Represents the degree to which overt adverse effects
can be tolerated by the subject.
Product Safety - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS The level of grouping of included terms typically
used in reporting frequency of occurance.
Included Term - CORRECT ANSWERS The lowest level of dictionary term to which the
investigator description is coded.
Non-inferiority Trial - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS A formal evaluation of the quantitative evidence
from two or more trials bearing on the same question
Interim Analysis - CORRECT ANSWERS 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 - CORRECT ANSWERS The property of yielding equivalent results
when used by the same rater on different occasions
inter-rater reliability - CORRECT ANSWERS The property of yielding equivalent results
when used by different raters on different occasions.
Qualitative interaction - CORRECT ANSWERS the direction of the contrast differs for at
least one level of the factor
, Quantitative Interaction - CORRECT ANSWERS The magnitude of the contrast differs at
the different levels of the factor
Intention-To-Treat Principle - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS The extent to which a variable (e.g. a rating
scale) measures what it is supposed to measure.
Double-Dummy - CORRECT ANSWERS 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 indistinguishable placebo). Subjects then take two sets of treatment; either A
(active) and B (placebo), or A (placebo) and B (active).
Dropout - CORRECT ANSWERS A subject in a clinical trial who for any reason fails to
continue in the trial until the last visit required of him/her by the study protocol.
Equivalence Trial - CORRECT ANSWERS A trial with the primary objective of showing
that the response to two or more treatments differs by an amount which is clinically unimportant.
