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Data from questionnaires, ratings, and scales (QRS) are represented in the Functional Tests (FT), Questionnaires (QS), and the the Disease Response and Clin Classification (RS) domains. 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.

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CDISC cannot produce supplements for copyrighted measures without the express permission of the copyright holder.

...

Full Name and Abbreviation

Copyright Permission Status

Supplement Status

Fagerstrom Test for Nicotine Dependence (FTND)GrantedIn Development
Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)Public DomainIn Development
Modified Cigarette Evaluation Questionnaire (mCEQ)GrantedIn Development
National Youth Tobacco Survey (NYTS) 2018 QuestionnairePublic DomainIn Development
Penn State Cigarette Dependence Index (PSCDI)Copyright ExemptIn Development
Questionnaire on Smoking Urges-Brief (QSU-Brief)GrantedIn Development
Generic Sponsor-Defined Questionnaire SupplementN/AIn Development

Sponsor-defined general single-Item assessment concepts. There are no published CDISC QRS Supplements for the evaluation of sponsor-defined general single-item assessments as they are not considered standard QRS instruments, but assess symptoms or other disease related items like overall quality of life, etc. These assessments may be evaluated using sponsor-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). There may be examples of these assessments in the literature, but they are not considered CDISC QRS standard instruments, 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. 

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

Include Page
SDTM Example.Visual Analog Scale
SDTM Example.Visual Analog Scale