ACRP CP CERTIFICATION EXAM NEWEST ACTUAL EXAM
COMPLETE 150 QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS)
|ALREADY GRADED A+
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.
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