CDASH Questionnaires, Ratings, and Scales (QRS)

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, Ratings, and Scales 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. Because the nature of QRS precludes implementers from modifying the published data collection structure, the CDASHIG metadata table does not include specifications for QRS. Instead, implementers should refer to instrument-specific QRS supplements on the QRS web page for example aCRFs, instrument-specific assumptions, and data examples.

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) in the SDTMIG.

Assumptions

1. 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 tabulation 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 QS domain utilizes 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 collection 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).
2. Electronic representations of QRS instruments should reflect the title, subheadings, and exact numbering and wording of questions as they appear in original versions.
3. Electronic response fields should allow either the original response (--ORRES) or coded value (--STRESC) to be input—but usually not both, to avoid discrepancies.
4. Checkboxes that appear on validated QRS instruments should remain checkboxes in the CRF/eCRF.
5. Copyrighted instruments may include the copyright notice on the eCRF/CRF. For more copyright Information about QRS instruments, see the QRS web page. 
6. Instrument-specific assumptions are included in the QRS supplements posted on the QRS web page.