ACRP-CP Exam Study Guide Questions and Answers Graded A 2024
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Course
ACRP-CP
Institution
ACRP-CP
Treatment Emergent -Correct Answer An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
treatment effect -Correct Answer An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of in...
ACRP-CP Exam Study Guide Questions
and Answers Graded A 2024
Treatment Emergent -Correct Answer ✔An event that emerges during treatment having
been absent pre-treatment, or worsens relative to the pre-treatment state.
treatment effect -Correct 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 -Correct 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 -Correct 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 -Correct 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 -Correct Answer ✔Represents the degree to which overt adverse effects can
be tolerated by the subject.
Product Safety -Correct 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 -Correct 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 -Correct Answer ✔The level of grouping of included terms typically used
in reporting frequency of occurance.
Included Term -Correct Answer ✔The lowest level of dictionary term to which the
investigator description is coded.
ACRP-CP Exam
,ACRP-CP Exam
Non-inferiority Trial -Correct 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 -Correct 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 -Correct Answer ✔A formal evaluation of the quantitative evidence from
two or more trials bearing on the same question
Interim Analysis -Correct 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 -Correct Answer ✔The property of yielding equivalent results when
used by the same rater on different occasions
inter-rater reliability -Correct Answer ✔The property of yielding equivalent results when
used by different raters on different occasions.
Qualitative interaction -Correct Answer ✔the direction of the contrast differs for at least
one level of the factor
Quantitative Interaction -Correct Answer ✔The magnitude of the contrast differs at the
different levels of the factor
Intention-To-Treat Principle -Correct 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 -Correct 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 -Correct 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 -Correct Answer ✔The extent to which a variable (e.g. a rating scale)
measures what it is supposed to measure.
ACRP-CP Exam
, ACRP-CP Exam
Double-Dummy -Correct 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 indistinguishable placebo). Subjects then take two sets
of treatment; either A (active) and B (placebo), or A (placebo) and B (active).
Dropout -Correct Answer ✔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 Answer ✔A trial with the primary objective of showing that
the response to two or more treatments differs by an amount which is clinically
unimportant. This is usually demonstrated by showing that the true treatment difference
is likely to lie between a lower and an upper equivalence margin of clinically acceptable
differences.
Frequentist Methods -Correct Answer ✔Statistical methods, such as significance tests
and confidence intervals, which can be interpreted in terms of the frequency of certain
outcomes occurring in hypothetical repeated realizations of the same experimental
situation.
Full Analysis Set -Correct Answer ✔The set of subjects that is as close as possible to
the ideal implied by the intention-to-treat principle. It is derived from the set of all
randomised subjects by minimal and justified elimination of subjects.
Generalisability, Generalisation -Correct Answer ✔The extent to which the findings of a
clinical trial can be reliably extrapolated from the subjects who participated in the trial to
a broader patient population and a broader range of clinical settings.
Global Assessment Variable -Correct Answer ✔A single variable, usually a scale of
ordered categorical ratings, which integrates objective variables and the investigator's
overall impression about the state or change in state of a subject.
Independent Data Monitoring Committee (IDMC) -Correct Answer ✔An independent
data-monitoring committee that may be established by the sponsor to assess at
intervals the progress of a clinical trial, the safety data, and the critical efficacy
endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
Bias (Statistical & Operational) -Correct Answer ✔The systematic tendency of any
factors associated with the design, conduct, analysis and evaluation of the results of a
clinical trial to make the estimate of a treatment effect deviate from its true value. Bias
introduced through deviations in conduct is referred to as 'operational' bias. The other
sources of bias listed above are referred to as 'statistical'.
Adverse Event (or Adverse Experience) -Correct Answer ✔Any untoward medical
occurrence in a patient or clinical investigation subject administered a pharmaceutical
ACRP-CP Exam
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