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Title

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

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 Version2.0
StatusREVISION DRAFT
Date2021-0708-2111
Notes
  • This 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.
  • This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. 


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DateVersionSummary of Changes
2021-0708-21112.0 Revision Draft
  • Converted the supplement to the current WIKI QRS supplement template.
  • Annotated CRF updated to the MSG V2.0 annotation guidelines
  • Added assumption 2 on using the QSEVINTX variable and added it to the example.
  • Added assumption 3 on the inclusion of 3 respiratory symptom scores and a total score 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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This document describes the CDISC implementation of thethe Exacerbations of Chronic Pulmonary Disease Tool (EXACT®) - Patient-Reported Outcome (EXACT) instrument.

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The Evaluating Respiratory Symptoms (E-RS™) in COPD (E-RS™: COPD) scale is part of the EXACT instrument.  It is comprised of 11 items (of the 14-item EXACT) which provide information specific to respiratory symptoms in stable COPD. The E-RS: COPD is not administered separately from the EXACT.  For this reason, a separate SDTM questionnaire supplement for the E-RS: COPD will not be developed. 

Instructions for scoring the EXACT and E-RS: COPD, done during analysis of a clinical trial, can be found in the user manuals provided from the copyright holder when copyright use permission is obtained. Both measures will have ADaM QRS Supplements explaining the scoring and total of the results based on the user manual.

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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

Note that the EXACT and E-RS have been validated for electronic administration (ePRO); pen-and-paper CRF administration is not recommended by the copyright holders.

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges principal author Nancy K. Leidy, EXACT-PRO Initiative, Evidera, Inc. for the approval to include the EXACT in the CDISC data standards.

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Nancy K. Leidy, EXACT-PRO Initiative, Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, MD; EXACT copyright 2013, Evidera, Inc. All rights reserved). This also includes the subset EXACT-Respiratory Symptoms (E-RS) questions. http://www.exactproinitiative.com .


3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

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