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Questionnaires, ratings, and scales (QRS) are standardized and often validated instruments. Given this, implementation of collection, tabulation, and analysis standards per this guide is specialized to maintain standardization inherent to instruments and, when applicable, the validity of validated instruments. CDISC 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 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 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 CDISC COP 001 at https://www.cdisc.org/about/bylaws for details on implementing or requesting development of standards for SDTM-based submissions.
Instrument Full Name and Abbreviation | Copyright Permission Status | Supplement Status |
|---|---|---|
| Fagerstrom Test for Nicotine Dependence (FTND) | Granted | In Development |
| Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) | Public Domain | In Development |
| Modified Cigarette Evaluation Questionnaire (mCEQ) | Granted | In Development |
| National Youth Tobacco Survey (NYTS) 2018 Questionnaire | Public Domain | In Development |
| Penn State Cigarette Dependence Index (PSCDI) | Copyright Exempt | In Development |
| Questionnaire on Smoking Urges-Brief (QSU-Brief) | Granted | In Development |
| Generic Sponsor-Defined Questionnaire Supplement | N/A | In Development |
QRS Supplements support guidance in the TIG by providing a single source for annotated CRFs, tabulation and analysis dataset content conventions, and controlled terminology for QRS instruments.
and the data collected using them are represented in tabulation domains datasets Questionnaires (QS), Disease Response and Clin Classification (RS), and Functional Tests (FT).
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The released QRS documentation is maintained on the CDISC QRS web page.
Description/Overview for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain
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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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Tabulation and analysis standards for questionnaires, ratings, and scales (QRS) are maintained as stand-alone supplemental guides on the CDISC website at https://www.cdisc.org/foundational/qrs. 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. 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 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 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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Instrument Full Name and Abbreviation
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Copyright Permission Status
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Supplement Status
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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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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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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.
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Overview
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