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 co...
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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.
Blind Review - 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 - ANSWER The extent to which a variable (e.g. a rating scale) measures what it is
supposed to measure.
Double-Dummy - 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 - 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 - 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 - 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 - 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 - 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 - 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) - 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) - 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) - ANSWER 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.
Adverse Drug Reaction (ADR) - ANSWER all noxious and unintended responses to a medicinal product
related to any dose should be considered adverse drug reactions.
Unexpected Adverse Drug Reaction - ANSWER An adverse reaction, the nature or severity of which is not
consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved
investigational medicinal product).
Applicable Regulatory Requirement(s) - ANSWER Any law(s) and regulation(s) addressing the conduct of
clinical trials of investigational products.
Approval (in relation to Institutional Review Boards) - ANSWER The affirmative decision of the IRB that
the clinical trial has been reviewed and may be conducted at the institution site within the constraints
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