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The FDA evaluates such instruments by their ability to measure specific concepts in a reliable and valid way.
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Additionally, even if the same concepts are measured, specific concepts might be measured in different ways, making comparisons across countries difficult.
Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue.
The process of assessing a PRO instrument's ability to measure a specific concept or collection of concepts.
Validation: The process of evaluating a PRO instrument's ability to measure a specific concept or collection of concepts accurately.
It is important to consider the procedures used to identify the set of items selected to measure a specific concept.
The GKAI was developed to measure specific domains of factual knowledge including concepts that are deemed important by professional organizations [ 42].
Unlike other international tests, which have focused on students' knowledge of specific concepts, the PISA test measures how students apply the sum of their education to new problems.
On this basis passive and active measures are presented in different depth from general aspects over specific concepts to some selected applications.
Concept signatures are used to retrieve or organize related documents, not specific concepts [ 6].
Archetypes can clearly represent the general concept and specific concepts by specialization.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com