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| Title | Exacerbations of Chronic Pulmonary Disease Tool (EXACT®) - Patient-Reported Outcome (PRO) (EXACT) |
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| CDISC Reference | QuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Approved |
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| Team | COPD Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 2.0 |
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| Status | REVISION DRAFT |
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| Date | 2022-0304-2106 |
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| 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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| Date | Version | Summary of Changes |
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| 2022-0304-2126 | 2.0 Revision Draft | - Converted the supplement to the current WIKI QRS supplement template.
- Updated the title by adding the QSCAT value at the end (e.g., ( EXACT) and match matching the full title stated in the User Manual.user manual
- 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 4 respiratory symptom raw and domain scores, a raw EXACT total, and an EXACT total scores score as described in the user manual.
- Added assumption 4 to describe how QRS planned diary data aligns with the QS domain timing variables.
- Added assumption 5 regarding the need for a record of each day of the study. The example was updated with a diary day having no responses.
- The QSEVAL assumption and variable was removed from this supplement , since because it is not captured on the CRF and no assumptions are made on the potential values.
- Updated the example to represent all 7 diary days related to VISITNUM = 1 to indicate the that dairy days are planned observations with the QSDTC dates represented.
- Revised the QSSTRESC and QSSTRESN values in the example and section 4 to values of "xxx" to represent numeric values based on the user manual describes on description of how these numeric values are represented.
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| 2016-03-24 | 1.0 | Final - Updated per Evidera instructions. They have trademarked the EXACT® and updated the name of the E-RS™: COPD. |
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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 comprises 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 supplements explaining the scoring and total of the results based on the user manual.
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2 Copyright Status
Evidera, Inc., owns the copyright for the EXACT instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.
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