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| Title | Name of QRS instrument (QRS Short_Name) |
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| CDISC Reference | Questionnaire (or 'Clinical Classification' or 'Functional Test', as appropriate) Supplement 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 (or 'Public Domain, Exempt from Copyright', as appropriate) |
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| Team | Standards team QRS instrument is being developed for (e.g., Major Depressive Disorder Standards Team), if applicable, and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 (or higher as appropriate when doing a supplement revision) |
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| Status | DRAFT (or "REVISION DRAFT" or "FINAL", as appropriate). Status will not be considered "Final" until the supplement is ready to be sent for publication. |
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| Date | yyyy-mm-dd (date current version released, regardless of status - this date should always match the date in the Revision History section below and should be updated every time this supplement is edited.) |
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| Notes to Readers | - This supplement is available 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. (COA #123, Qualified Clinical Outcome Assessments (COA) | FDA) (Use only for instruments this applies to; update COA #.)
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| Known Issues | Only include this row to describe any known issues related to the supplement. If there are no issues, this row can be deleted. |
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The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.
These The specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS QRS (spell out "questionnaires, ratings, and scales" if this is a CDISC-created CRF and put QRS in parentheses.) documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.
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For public domain instruments use the following text: CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the QRS Short_Name in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.
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