Page 48 - Terminology-Clinical-Research

the patient but not recorded directly.

Proxy respondent: Someone other than the patient who is
responding about the patient on behalf of the patient, not as Q
an observer.

Psychometric reliability: See Reliability, Psychometric.
Qualitative variable: One that cannot be measured on
Psychometric validation: The specialized process of
validating questionnaires used in outcomes research to a continuum and represented in quantitative relation to a
show that they measure what they purport to measure. scale (race or sex, for example). Data that fit into discrete
NOTE: Several types of validity are distinguished. For categories according to their attributes.
example, face validity means that an assessment instrument Quality assurance (QA): All those planned and
appears by inspection and consideration of the semantic systematic actions that are established to ensure that the
content of items in it to be measuring what it is supposed trial is performed and the data are generated, documented
to measure. Construct validity means that a scale based on (recorded), and reported in compliance with good
one or more items measures an unobservable psychological clinical practice (GCP) and the applicable regulatory
construct (e.g., “distress”) that it is proposed to measure. requirement(s).
Construct validity is usually tested by measuring the
correlation in assessments obtained from several scales Quality control (QC): The operational techniques and
purported to measure the same construct. activities undertaken within the quality assurance system to
verify that the requirements for quality of the trial related
Psychometrics: The science of assessing the measurement activities have been fulfilled.
characteristics of scales that assess human psychological
characteristics. Quality of life (QoL): A broad ranging concept that
incorporates an individual’s physical health, psychological
Public disclosure of trial results: Consists of the state, level of independence, social relationships, personal
publication of trial results in a peer reviewed journal, beliefs, and their relationships to salient features of the
and the posting of aggregate (summary) data and micro environment. Note: Quality of Life is one way to measure
(individual participant) level data on an unbiased freely the benefits or negative impacts of an “improvement”
accessible results website. measured in terms of a physiological or psychological
symptom. QOL research seeks to quantify what an
Publications: Published scientific articles or abstracts
about a clinical study. A publication reference, also called intervention means to a patient’s sense that their life has
a citation, may be submitted to ClinicalTrials.gov at changed.
any time. It can also be automatically identified by the Quality of life trials (or Supportive care trials): Refers to
ClinicalTrials.gov Identifier (NCT Number), which is trials that explore ways to improve comfort and quality of
indexed in MEDLINE®, a database of biomedical and life life for individuals with a chronic illness.
sciences journal citations.
Quantitative variables: One that can be measured and
P-value (Probability values): A p-value is the likelihood reported numerically to reflect a quantity or amount, ideally
of obtaining a statistical result by chance, assuming there on a continuum.
is no difference between the treatments being investigated.
The lower the p-value the less likely the result happened by Query: A request for clarification on a data item collected
chance, and the more likely the result can be attributed to for a clinical trial; specifically a request from a sponsor or
the drug being tested. The p-value which is considered to sponsor’s representative to an investigator to resolve an
be significant can vary, but is usually set at 0.05. A p value error or inconsistency discovered during data review.
of 0.05 means that there is only a 5% likelihood that the
result happened by chance – and therefore that the result is Query management: Ongoing process of data review,
due to a true difference between the treatment effects and discrepancy generation, and resolving errors and
not chance alone. inconsistencies that arise in the entry and transcription of
clinical trial data.

Query resolution: The closure of a query usually based on
information contained in a data clarification.

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