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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, 

Standard conventions for implementation 

Tabulation and analysis standards for questionnaires, ratings, and scales (QRS) are maintained as stand-alone supplemental guides on the CDISC website at https://www.cdisc.org/foundational/qrs.

CDISC QRS Supplements guide implementation of tabulation and analysis standards and should be referred to as supplemental materials to this guide.  

There are no published CDISC QRS Supplements for the evaluation of sponsor-defined general single-item assessments as they are not considered standard QRS instruments, but assess symptoms or other disease related items like overall quality of life, etc. These assessments may be evaluated using sponsor-defined general codelist scales, visual analog scales (VAS) or numeric rating scales (NRS). VAS and NRS Scales use various methods for describing the anchor points and may have descriptor anchors (e.g., beginning, middle and end) for various gradations or numbers). There may be examples of these assessments in the literature, but they are not considered CDISC QRS standard instruments, due to the extreme variability in the methods of capturing these types of assessments. These assessments may be in the public domain or may be copyrighted. Sponsors are responsible for the appropriate usage of any copyrighted assessments. These general single-item assessments are represented in the FA-- domain. 

• The Findings About Events or Interventions (FA–)  is a specialization of the Findings general observation class. As such, it shares all qualities and conventions of Findings observations but is specialized by the addition of the --OBJ variable.

Example

This is an example of a single item visual analog scale (VAS) used to assess the level of craving based on response to the question “ In the past 24 hours, how strong is your craving for cigarettes?” on a scale from “no craving” to “strong craving” by measuring the number of millimeters (0–100 mm) from the “no craving” dot to the point at which the drawn line intersected the scale.

The Findings About Events or Interventions (FA) domain was used to represent the assessment of craving. Sponsors may represent findings data in a single FA dataset or split the FA domain into separate datasets, following the guidance in the guide. In this example, a FACE dataset was used. The craving itself is considered a clinical event, whereas the evaluation of craving at specific time points are considered findings about the clinical event.  A parent record in the CE domain is not required.

This example illustrates how information on the scale scoring may be represented as supplemental qualifier variables. A record in a SUPPFA dataset relates back to the parent record(s) via the key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. Here the parent domain (RDOMAIN) is FA, and IDVAR is FASEQ. QNAM holds the name of the supplemental qualifier variable being defined. 

All QRS questions and reply choices are presented as validated in the CRF to maintain the validity. In some cases, this may result in CRFs that do not conform to CDASH best practices. The use of such questionnaires in their native format should not be considered to affect conformance to CDASH.

All QRS questions and reply choices are presented as validated in the CRF to maintain the validity of a validated instrument. In some cases, this may result in CRFs that do not conform to CDASH best practices; however, restructuring these questionnaires should not be done because it could invalidate them. The use of such questionnaires in their native format should not be considered to affect conformance to CDASH.

Description/Overview for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain

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 for the CDASHIG QRS - Questionnaires, Ratings, and Scales Domain

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 

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