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Description

The TIG does not include metadata specifications for QRS because the nature of QRS precludes implementers from modifying the published data collection structure. Please refer to Section x.x, Guidance for Questionnaires (QS) is a Findings domain used for data from named stand-alone instruments designed to provide an assessment of a concept. Questionnaires have a defined standard structure, format, and content; consist of conceptually related items that are typically scored; and have documented methods for administration and analysis. Refer to Section 2.4, About Questionnaires, Ratings, and Scales when to implement collection standards.

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.

The CDISC QRS web page describes the development methodology for new QRS terminology. implementing collection standards. Because the nature of QRS precludes implementers from modifying the published data collection structure, the CDASHIG TIG collection metadata table does not include specifications for QRS. Instead, implementers should refer to instrument-specific QRS supplements on the QRS web page for page for example aCRFs, instrument-specific assumptions, and data examples.

For Released QRS documentation is maintained on the CDISC QRS web page (https://www.cdisc.org/standards/foundational/qrs); see that page 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

Reference the QRS supplements posted on the QRS web page and the specifications for specific domains (QS, RS, and FT) tabulation QS specification in the SDTMIGTIG.

Assumptions

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