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This document describes the CDISC implementation of the Title

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

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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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.  (Include this line only for supplements that the US FDA will be reviewing.  Please DO NOT MODIFY the sentence.)

2 Copyright Status

For copyrighted instruments use the following text:  Name of copyright holder (e.g., Board of Regents of The University of Texas System) owns the copyright for the QRS Short_Name instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. (For supplements that are to be distributed by the copyright holder, add: Name of copyright holder (e.g., Board of Regents of The University of Texas System) will distribute the CDISC supplement package to sponsors when they are approved to use this instrument.) Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the questionnaire. 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.

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Info

Include the following statements as standalone paragraphs for copyrighted instruments:

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 [insert the name of the copyright holder, in blue text] (e.g., Dr. A. J. Rush, at the UT Southwestern Medical Center) for the approval to include the QRS Short_Name in the CDISC data standards.

Reference for the Titlethe Exacerbations of Chronic Pulmonary Disease Tool (EXACT®) - Patient-Reported Outcome:

Rush, A.J., Carmody, T. and Reimitz, P.E. The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and self-report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9:45-59, 2000. 

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