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Guidance for 

General guidance for use of controlled terminology and formats is provided in this section with detailed instructions provided as part of sections specific to collection, 

Standard conventions for implementation 

Tabulation and analysis standards for questionnaires, ratings, and scales (QRS) Questionnaires, ratings, and scales (QRS) are 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, 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 supplemental guides available on the QRS page of the CDISC website at https://www.cdisc.org/foundational/qrs.

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 instrumentsCDISC 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. 

The following table lists assessments that are being pursued as potential supplements as part of the development work for this guide. Supplements 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, as it may have been developed outside of the scope for this guide; new measures are implemented an ongoing basis by the CDISC QRS Terminology and Standards Development subteams. See . 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 https://www.cdisc.org/about/bylaws for for details on implementing or requesting development of CDISC standards for SDTM-based submissions.

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CDISC QRS Supplements guide implementation of tabulation and analysis standards and should be referred to as supplemental materials to this guide.  

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• The Findings About Events or Interventions (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

This is an example of a single item visual analog scale (VAS) used to assess the level of craving based on response to the question “ In the past 24 hours, how strong is your craving for cigarettes?” on a scale from “no craving” to “strong craving” by measuring the number of millimeters (0–100 mm) from the “no craving” dot to the point at which the drawn line intersected the scale.

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This example illustrates how information on the scale scoring may be represented as supplemental qualifier variables. A record in a SUPPFA dataset relates back to the parent record(s) via the key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. Here the parent domain (RDOMAIN) is FA, and IDVAR is FASEQ. QNAM holds the name of the supplemental qualifier variable being defined. 

All QRS questions and reply choices are presented as validated in the CRF to maintain the validity. In some cases, this may result in CRFs that do not conform to CDASH best practices. The use of such questionnaires in their native format should not be considered to affect conformance to CDASH.

All QRS questions and reply choices are presented as validated in the CRF to maintain the validity of a validated instrument. In some cases, this may result in CRFs that do not conform to CDASH best practices; however, restructuring these questionnaires should not be done because it could invalidate them. The use of such questionnaires in their native format should not be considered to affect conformance to CDASH.

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

Questionnaires, ratings, and scales (QRS) are standardized and often validated instruments, 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 (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.

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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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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/standards/foundational/qrs).