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

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(RS) domains . Refer to (see Section 2.4, About Questionnaires, Ratings, and Scales for information.)

There are no published CDISC QRS Supplements supplements for the evaluation of applicant-defined general single-item assessments. These instruments assess symptoms or other disease-related items like (e.g., overall quality of life, etc), and may be evaluated using applicant-defined general codelist scales, visual analog scales (VAS), or numeric rating scales (NRS). VAS and NRS Scales use various methods for describing the anchor points and may have descriptor anchors (e.g., beginning, middle and , end) for various gradations or numbers). . These assessments may be in the public domain or may be copyrighted. Applicants are responsible for the appropriate usage 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.

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