Data from QRS instruments are represented in the Functional Tests (FT), Questionnaires (QS), and the Disease Response and Clin Classification (RS) domains. Refer Section x.x, Guidance for Questionnaires, Ratings, and Scales for examples.
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 VAS used to assess the level of craving (i.e., 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.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.
The FA domain was used to represent the assessment of craving. Applicants may represent findings data in a single FA dataset or split the FA domain into separate datasets. In this example, a FACE dataset was used, indicating that data are findings about clinical events. The craving itself is considered a clinical event, whereas craving at specific time points is considered findings about the clinical event. A parent record in the Clinical Events (CE) domain is not required.
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