CDASH Questionnaires, Ratings, and Scales (QRS)

Description

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 implementing collection standards. Because the nature of QRS precludes implementers from modifying the published data collection structure, the TIG collection metadata 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.

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.

Specification

Reference the QRS supplements posted on the QRS web page and the tabulation QS specification in the TIG.

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.