Page 62 - Terminology-Clinical-Research

studied) or a standard treatment – one in wide use and VAPAHCS: Veterans Affairs Palo Alto Health Care
considered effective at the time the trial is designed. System.
Although a placebo is sometimes used as a control in
clinical trials, it is rarely used in cancer trials, where there Variable: 1. Any entity that varies; any attribute,
may be ethical issues with this approach. It is important to phenomenon, or event that can have different qualitative
note that because some clinical trials take months or even or quantitative values. 2. In SDTM “variables” are used
years to complete, the standard treatment may no longer be to describe observations. Such describing variables have
in wide use by the time results from the trial are reported. roles that determine the type of information conveyed by
the variable about each observation and how it can be used.
User site testing (UST): Any testing that takes place Note: 1. There is usually a form of metadata that goes with
outside of the developer’s controlled environment. Note: the variable, there is a variable definition that describes
Terms such as beta test, site validation, user acceptance what is varying, and there is a value for the variable. In
test, installation verification, and installation testing have the context of a protocol, variables pertain to the study.
all been used to describe user site testing. User site testing 2. In SDTM a “study variable” would be an observation.
encompasses all of these and any other testing that takes Variable is an enveloping term that includes specific
place outside of the developer’s controlled environment. subtypes used in clinical research. “Study variable” is a
term used in trial design to denote a variable to be captured
on the CRF. An “assessment” is a study variable pertaining
to the status of a subject. Assessments are usually measured
V at a certain time, and usually are not compounded

significantly by combining several simultaneous
measurements to form a derived assessment (e.g., BMI) or
a result of statistical analysis. An “endpoint” is a variable
VA: Veterans Administration. that pertains to the trial objectives. Not all endpoints are
themselves assessments since certain endpoints might
Valid: 1. Sound. 2. Well-grounded on principles of apply to populations or emerge from analysis of results.
evidence. 3. Able to withstand criticism or objection. That is, endpoints might be facts about assessments
(e.g., prolongation of survival). When a “variable” is
Validation: 1. Process of establishing suitability to captured or measured, there is no necessary sense that
purpose. 2. For software and systems, establishing any evaluation or judgment is involved. However, when
documented evidence which provides a high degree of a variable is to be measured that obviously or actively
assurance that a specific process will consistently produce pertains to subject status, which is always the concern of
a product meeting its predetermined specifications and the physician, that variable becomes or will always be an
quality attributes. Note: Validation is accomplished by assessment. The term assessment is intended to invoke
planning how to measure and/or evaluate suitability to some degree of evaluation or judgment concerning subject
purpose; then executing the plan and documenting the status. A parameter is most properly a variable pertaining
results. to statistical distributions though the word is often used
synonymously with variable by engineers.
Validation data: 1. A process used to determine if data
are inaccurate, incomplete, or unreasonable. The process Variance: A measure of the variability in a sample or
may include format checks, completeness checks, check population. It is calculated as the mean squared deviation
key tests, reasonableness checks and limit checks. 2. (MSD) of the individual values from their common mean.
The checking of data for correctness or compliance In calculating the MSD, the divisor n is commonly used
with applicable standards, rules, and conventions. Note: for a population variance and the divisor n-1 for a sample
Meaning 1 is not “data verification” but meaning 2 could variance.
be [1. ISO. 2. FDA Glossary of Computerized System and
Software Development Terminology]. Verification: 1. The act of reviewing, inspecting,
testing, checking, auditing, or otherwise establishing
Validity: See Validation. and documenting whether items, processes, services,
or documents conform to specified requirements. 2. (of
Validity, psychometric: See Psychometric validation.
software). Provides objective evidence that the design
Valued ecosystem components: Elements of an ecosystem outputs of a particular phase of the software development
that are highly valued by the public. life cycle meet all of the specified requirements for that

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