Page History

Data from questionnaires, ratings, and scales (QRS) QRS instruments are represented in the Functional Tests (FT), Questionnaires (QS), and the the Disease Response and Clin Classification (RS) domains. These domian are all based on the Findings General Observation Class, CDISC develops controlled terminology and publishes supplements for individual QRS instruments when the instrument is in the public domain or when permission has been granted by the copyright holder. Questionnaires, ratings, and scales (QRS) are maintained as stand-alone guides on the CDISC website at https://www.cdisc.org/foundational/qrs. The following table lists assessments that are being pursued as potential supplements as part of the development work for this guide. Supplements may or may not be finalized at the time of publication of this user guide, and depend on copyright approval where applicable.Clinical Classification

Sponsors should refer to the QRS page of the CDISC website if a measure of interest is not included in the table, as it may have been developed for another therapeutic area; new measures are implemented on an ongoing basis by the CDISC QRS Terminology and Standards Development subteams. See CDISC COP 001 at https://www.cdisc.org/about/bylaws for details on implementing or requesting development of standards for SDTM-based submissions.

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Full Name and Abbreviation

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Copyright Permission Status

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Supplement Status

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There are no published CDISC QRS Supplements supplements for the evaluation of sponsorapplicant-defined general single-item assessments as they are not considered standard QRS instruments, but . These instruments assess symptoms or other disease-related items like (e.g., overall quality of life), etc. These assessments and may be evaluated using sponsorapplicant-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 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 instrumentsdevelopment purposes, due to the extreme variability in the methods of capturing these types of assessments. These assessments may be in the public domain or may be copyrighted. Sponsors are responsible for the appropriate usage of any copyrighted assessments.

These general single-item assessments are represented in the FA-- domain. 

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Findings About Events or Interventions (

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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.