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Data from QRS instruments are represented in the Functional Tests (FT), Questionnaires (QS), and Disease Response and Clinical Classification

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(RS) domains (see Section 2.4, About Questionnaires, Ratings, and Scales). 

There are no published CDISC QRS supplements for the evaluation of applicant-defined general single-item assessments. These instruments assess symptoms or other disease-related items (e.g., overall quality of life), and may be evaluated using applicant-defined general codelist scales, visual analog scales (VAS), or numeric rating scales (NRS). VAS and NRS use various methods for describing the anchor points and may have descriptor anchors (e.g., beginning, middle, end) for various gradations or numbers. These assessments may be in the public domain or may be copyrighted. Applicants are responsible for the appropriate use of any copyrighted assessments. There may be examples of these assessments in the literature, but they are not considered CDISC QRS instruments for standard development purposes, due to the extreme variability in the methods of capturing these types of assessments.

These general single-item assessments are represented in the Findings About Events or Interventions (FA) domain.

FA is a specialization of the Findings general observation class. As such, it shares all qualities and conventions of Findings observations but is specialized by the addition of the --OBJ variable.

Example

Include Page
SDTM Example.Visual Analog Scale
SDTM Example.Visual Analog Scale

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