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The TIG provides general guidance for the implementation of collection, tabulation, and analysis standards for QRS instruments.
standardized use of controlled terminology and formats is provided in this section with detailed instructions provided as part of sections specific to collection, tabulation, and analysis standards.
The TIG provides general guidance for standardized CRF collection and tabulation and analysis datasets for QRS data.
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 annotated CRFs, 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. 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 CDISC standards.
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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 |
General guidance for the implementation of collection, tabulation, and analysis standards for QRS instruments
standardized use of controlled terminology and formats is provided in this section with detailed instructions provided as part of sections specific to collection, tabulation, and analysis standards.
and the data collected using them are represented in tabulation domains datasets 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.
The CDISC QRS web page describes the development methodology for new QRS terminology.
Assumptions for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain
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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,
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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
- CDISC standards for QRS include controlled terminology for test codes (--TESTCD), test names (--TEST), standard timing values, standard results for database values, and an aCRF with SDTMIG domain variable names. These standards can be used to create an electronic data collection (EDC) structure following the same conventions that would be used for any Findings class domain. The SDTMIG QS, RS, and FT domains utilize a normalized data structure; that is, 1 variable (--TEST) is used to capture the test name and another variable (--ORRES) is used to capture the result. Even though these domain variables are presented as a normalized structure in the CDASHIG metadata table, implementers using a denormalized structure (1 variable for each test) should create variable names that mirror the values in QRS Controlled Terminology (e.g., QSTESTCD, RSTESTCD, FTTESTCD).
- Electronic representations of QRS instruments should reflect the title, subheadings, and exact numbering and wording of questions as they appear in original versions.
- Electronic response fields should allow either the original response (--ORRES) or coded value (--STRESC) to be input—but usually not both, to avoid discrepancies.
- Checkboxes that appear on validated QRS instruments should remain checkboxes in the CRF/eCRF.
- Copyrighted instruments may include the copyright notice on the eCRF/CRF. For more copyright Information about QRS instruments, see the QRS web page.
- Instrument-specific assumptions are included in the QRS supplements posted on the QRS web page.
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