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Title


Exacerbations of Chronic Pulmonary Disease Tool (EXACT®) - Patient-Reported Outcome


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

EXACT

QRS Permission StatusApproved
TeamCOPD Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version12.10
StatusREVISION DRAFT
Date2019-12-05
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
2019-12-0512.1 0 Revision Draft
  • Converted the supplement to the current WIKI QRS supplement template.
  • Added the assumption 2 on using the QSEVINTX variable and added it to the example.
  • Added the assumption 3 on the inclusion of subtotal and total scores as Electronic Data Transfer (eDT).
  • Added assumption 5 regarding the need for a record of reach day of the study. The example was updated with a day having no responses.
  • The QSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
2016-03-241.0

Final - Updated per Evidera instructions.  They have trademarked the EXACT® and updated the name of the E-RS™: COPD.

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