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Title

Kurtzke Expanded Disability Status Scale (EDSS)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

EDSS

QRS Permission StatusPublic Domain
TeamMultiple Sclerosis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.0
StatusDRAFT
Date2020-08-0315
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


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DateVersionSummary of Changes
20192020-08-03152.0 Draft
  • This measure was re-evaluated to fit the definition of a clinical classification measure.  The domain was changed from the QS to RS domain.
  • The EDSS v2.0 supplement was updated to the WIKI clinical classifications supplement template.
  • The RSEVAL assumption was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values to include in the example.
  • The example was reduced from 20 to 15 subjects. The original VISITNUM = 2 was revised to 1 and the RSLOBXFL variable was added to represent a baseline response.
  • Updated the example by adding USUBJID = "P0016" to represent how a missing visit is handled when the instrument was not filled out.
2013-10-231.0

Final

© 2019 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

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

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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.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

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CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the EDSS in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

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