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Description/Overview for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain

Questionnaires, ratings, and scales (QRS) are standardized and used to assess the impact of tobacco products on the health of individuals and populations. QRS are standardized and often validated instruments. Given this, implementation of collection, tabulation, and analysis standards per this guide is specialized to maintain instrument standardization and the data collected using them are represented in SDTMIG domains including Questionnaires (QS), Disease Response and Clin Classification (RS), and Functional Tests (FT). See the SDTMIG or the QRS web page (, when applicable, the validity of validated instruments. CDISC provides descriptions for different types of QRS instruments and develops and publishes supplemental guidance for individual QRS instruments when the instrument is in the public domain or when permission has been granted by the copyright holder. CDISC QRS supplements are maintained as stand-alone guides available on the QRS page of the CDISC website at https://www.cdisc.org/foundational/qrs) for complete information on these domains. CDISC publishes supplemental specifications called QRS supplements, including example annotated CRFs (aCRFs) for many of these instruments.

The CDISC QRS web page describes the development methodology for new QRS terminology. Because the nature of QRS precludes implementers from modifying the published data collection structure, the CDASHIG metadata table does not include specifications for QRS. Instead, implementers should refer to instrument-specific QRS supplements on the QRS web page for example aCRFs, instrument-specific assumptions, and data examples.

For definitions and descriptions of the different types of questionnaires, ratings, and scales, visit the QRS web page.

The released QRS documentation is maintained on the CDISC QRS web page.

Specification for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain

Reference the QRS supplements posted on the QRS web page and the specifications for specific domains (QS, RS, and FT) in the SDTMIG.

Assumptions for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain 

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The TIG provides general guidance for the implementation of collection, tabulation, and analysis standards for QRS instruments. QRS supplements are used with the TIG to describe detailed guidance for implementation. QRS supplements support guidance in the TIG by providing a single source for standard annotated CRFs for collection, tabulation, and analysis dataset content conventions; controlled terminology; and examples for QRS instruments. 

The following table lists assessments that are being pursued as potential supplements as part of the development work for this guide. QRS supplements are managed as publications separate from this guide, may or may not be finalized at the time of publication of this guide, and depend on copyright approval where applicable.CDISC cannot produce supplements for copyrighted measures without the express permission of the copyright holder. Users of this guide can refer to the QRS page of the CDISC website if a measure of interest is not included in the table. New measures are developed on an ongoing basis and all supplements are made available on the website as they are developed. See CDISC COP 001 at

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Example CRF for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain

See the examples in the QRS supplements posted on the QRS web page (https://www.cdisc.org/about/standards/foundational/qrs).bylaws for details on implementing or requesting development of CDISC standards.