Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

The representation of data collected for this clinical classification is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.  

These specific implementation details for this clinical classification are meant to be used in conjunction with the SDTMIG. All clinical classifications documentation can be found on the CDISC web site at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC web site at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

...

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

2 Copyright Status

This measure is CDISC believes this instrument is to be in the public domain, but you should perform your own assessment. CDISC has included the ASSIGN Cardiovascular Disease 10-Year Risk Score (ASSIGN CVD 10-YEAR RISK) as part of CDISC Data Standards. Hence in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for the ASSIGN Cardiovascular Disease 10-Year Risk Scoreeach item based on the actual text on the instrument. There may be many versions of this questionnaire in the public domain or copyright questionnaireinstrument. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this measure consists of: (1) controlled terminology, (2) standard database structure with examples.

Note: CDISC controlled terminology Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website . (httpat: https://www.cdisc.org/standards/terminology/controlled-terminology).

Further information about the ASSIGN CVD 10-YEAR RISK can be found in the following article: Woodward M, Brindle P, Tunstall-Pedoe H, for the SIGN group on risk estimation. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the Scottish Heart Health Extended Cohort (SHHEC). Heart 2007; 93: 172-176.

...