Page History

Data from QRS instruments are represented in the Functional Tests (FT), Questionnaires (QS), and the Disease Response and Clin Classification (Clinical Classification

There are no published CDISC QRS Supplements supplements for the evaluation of sponsorapplicant-defined general single-item assessments as they are not considered standard QRS instruments, but . These instruments assess symptoms or other disease-related items like (e.g., overall quality of life), etc. These assessments and may be evaluated using sponsorapplicant-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). These assessments may be in the public domain or may be copyrighted. Applicants are responsible for the appropriate use of any copyrighted assessments. There may be examples of these assessments in the literature, but they are not considered CDISC QRS instruments for standard instrumentsdevelopment purposes, 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. 

...

Findings About Events or Interventions (

...

FA) domain.

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.