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ACRP-CP Exam test guide with actual questions and answers
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ACRP-CP Exam test guide with actual questions and answers
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ACRP-CP Exam test guide with actualquestions and answers
Treatment Emergent - ANS An event that emerges during treatment having been absent
pre-treatment, or worsens relative to the pre-treatment state.
treatment effect - ANS 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 - ANS A variable that provides an indirect measurement of effect in
situations where direct measurement of clinical effect is not feasible or practical.
Superiority Trial - ANS 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 - ANS 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 - ANS Represents the degree to which overt adverse effects can be tolerated by
the subject.
Product Safety - ANS 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 - ANS 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 - ANS The level of grouping of included terms typically used in reporting
frequency of occurance.
Included Term - ANS The lowest level of dictionary term to which the investigator
description is coded.
,Non-inferiority Trial - ANS 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 - ANS 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 - ANS A formal evaluation of the quantitative evidence from two or more
trials bearing on the same question
Interim Analysis - ANS 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 - ANS The property of yielding equivalent results when used by the
same rater on different occasions
inter-rater reliability - ANS The property of yielding equivalent results when used by different
raters on different occasions.
Qualitative interaction - ANS the direction of the contrast differs for at least one level of the
factor
Quantitative Interaction - ANS The magnitude of the contrast differs at the different levels of
the factor
Intention-To-Treat Principle - ANS 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 - ANS 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 - ANS 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 - ANS The extent to which a variable (e.g. a rating scale) measures what it
is supposed to measure.
, Double-Dummy - ANS 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 - ANS 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 - ANS 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 - ANS 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 - ANS 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 - ANS 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 - ANS 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) - ANS 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) - ANS 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) - ANS Any untoward medical occurrence in a
patient or clinical investigation subject administered a pharmaceutical product and which does
not necessarily have to have a causal relationship with this treatment.
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