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| Title | 4-Stair Ascend (4-STAIR ASCEND) |
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| CDISC Reference | Functional Test 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 | Public Domain |
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| Team | Duchenne Muscular Dystrophy (DMD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | DRAFT |
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| Date | 20232024-0802-2509 |
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| Notes | 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. |
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Revision History
| Date | Version |
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20232024-0802-2509
| 1.0 Draft |
© 2023 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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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 implement 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.
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| Dataset wrap |
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| Rowcaps |
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| Rows 1-4: | Show a subject who refused to do the test. All 4 questions were marked as not done with the reason written at the top of the CRF. | | Rows 5-8: | Show a subject who was not able to do the test due to disease progression. Rows 6 and 7 are logically skipped items because the subject was not able to do the 4-stair ascend. The test grade is shown on row 8. | | Rows 9-12: | Show a subject who was able to complete the test. | |
| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | FTSEQ | FTTESTCD | FTTEST | FTCAT | FTORRES | FTSTRESC | FTSTRESN | FTSTAT | FTREASND | FTLOBXFL | VISITNUM | FTDTC |
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| 1 | STUDYX | FT | 1001-001 | 1 | A4STR101 | A4STR1-Was 4-Stair Ascend Performed | 4-STAIR ASCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 2 | STUDYX | FT | 1001-001 | 2 | A4STR102 | A4STR1-Time to Do 4-Stair Ascend | 4-STAIR ASCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 3 | STUDYX | FT | 1001-001 | 3 | A4STR103 | A4STR1-Wear Orthoses | 4-STAIR ASCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 4 | STUDYX | FT | 1001-001 | 4 | A4STR104 | A4STR1-Test Grade | 4-STAIR ASCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 5 | STUDYX | FT | 1001-002 | 1 | A4STR101 | A4STR1-Was 4-Stair Ascend Performed | 4-STAIR ASCEND | No, Due to disease under study | No, Due to disease under study |
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| Y | 1 | 2015-05-15 | | 6 | STUDYX | FT | 1001-002 | 2 | A4STR102 | A4STR1-Time to Do 4-Stair Ascend | 4-STAIR ASCEND |
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| NOT DONELOGICALLY SKIPPED ITEM |
| Y | 1 | 2015-05-15 | | 7 | STUDYX | FT | 1001-002 | 3 | A4STR103 | A4STR1-Wear Orthoses | 4-STAIR ASCEND |
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| NOT DONELOGICALLY SKIPPED ITEM |
| Y | 1 | 2015-05-15 | | 8 | STUDYX | FT | 1001-002 | 4 | A4STR104 | A4STR1-Test Grade | 4-STAIR ASCEND | Unable to climb up 4 standard stairs| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-611 |
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. | 1 | 1 |
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| Y | 1 | 2015-05-15 | | 9 | STUDYX | FT | 1001-003 | 1 | A4STR101 | A4STR1-Was 4-Stair Ascend Performed | 4-STAIR ASCEND | Yes |
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| Y | 1 | 2015-05-15 | | 10 | STUDYX | FT | 1001-003 | 2 | A4STR102 | A4STR1-Time to Do 4-Stair Ascend | 4-STAIR ASCEND | PT13S | PT13S | PT13S |
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| Y | 1 | 2015-05-15 | | 11 | STUDYX | FT | 1001-003 | 3 | A4STR103 | A4STR1-Wear Orthoses | 4-STAIR ASCEND | No | N |
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| Y | 1 | 2015-05-15 | | 12 | STUDYX | FT | 1001-003 | 4 | A4STR104 | A4STR1-Test Grade | 4-STAIR ASCEND | Climbs 4 standard stairs “marking time” (climbs 1 foot at a time, with both feet on a step before moving to next step), using both arms on one or both handrails. | 2 | 2 |
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| Y | 1 | 2015-05-15 |
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The conditionally branched item flag text value for data collection needs to be populated in SUPPFT as follows. The standard terminology for QNAM and QLABEL are listed below. | Dataset wrap |
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| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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| STUDYX | FT | 1001-002 | QSSEQ | 2 | FTCBRFL | Conditionally Branched Item Flag | Y | CRF | | STUDYX | FT | 1001-002 | QSSEQ | 3 | FTCBRFL | Conditionally Branched Item Flag | Y | CRF |
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4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM FT domain. It also provides guidance on how the result variables| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-612 |
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(FTORRES, FTSTRESC, and FTSTRESN) should be populated.
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