Page History
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
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and depend on copyright approval where applicable.CDISC cannot produce supplements for copyrighted measures without the express permission of the copyright holder.
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Users of this guide can refer to the QRS page of the CDISC website if a
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measure of interest is not included in the table, as it may have been developed for another therapeutic area;
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new measures are implemented on an ongoing basis by the CDISC QRS Terminology and Standards Development subteams. See CDISC COP 001
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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 | 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 |
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
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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