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- 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 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 SDTMIG QS, RS, and FT domains utilize 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 CDASHIG 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).
- 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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