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Title | Chronic Respiratory Questionnaire - Self-Administered Standardized Format Follow-up Administration Version (CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION) |
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CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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QRS Short Name | CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION |
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QRS Permission Status | ApprovedAuthor Permission Required |
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Team | 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 | 2023-04-13 |
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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.
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Date | Version | Summary of Changes |
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2023-04-13 | 2.0 | - Converted the supplement to the current WIKI QRS supplement template.
- Annotated CRF updated to the MSG V2.0 annotation guidelines
- Copyright Status section was updated based on the latest Memorandum of Understanding signed between McMaster
University and CDISC. - Reference for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION was updated to retain only the valid hyperlinks.
- Updated the assumption to clarify that the CRQ-SAS First Administration consists of 20 items with each item graded on a 7-point or 8-point Likert scale.
- Updated assumption 1.a to specify users need to follow the scoring solution in their approved copyright permission when the result is“8 = Not Done”.
- Removed the QSEVAL assumption and variables as this is not captured on the CRF and no assumptions are made on potential values.
- An additional subject was added to the data example to show how missing data is handled when the instrument was not completed.
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2015-02-18 | 1.0 | Initial Final Version |
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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.
2 Copyright Status
McMaster University owns the copyright for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. McMaster University 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 instrument.
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