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| Title | 4-Stair Descend (4-STAIR DESCEND)
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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 | 2022-06-0103 |
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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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Revision History
| Date | Version |
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2022-06-0103
| 1.0 Draft |
© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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- The numerical value for the time to complete the 4-STAIR DESCEND is recorded using ISO8601 ISO 8601 format in FTORRES and FTSTRESC. Because ISO 8601 format is a text format, there are no standard numeric scores or units. The sponsor enters the time on the CRF in minutes and seconds according to their protocol. (e.g., 1 minute 10 seconds is represented in the FT domain in ISO 8601 format as "T1M10S")
For the test grade (where FTTESTCD = "D4STR104"), FTORRES is populated with the text description. The numeric rating is represented in FTSTRESC and FTSTRESN.
If the entire instrument was not done, the first question on the CRF represents the reason the entire instrument was not done. If the reason not done is provided, then FTSTAT = "NOT DONE" and FTREASND is equal to the text written on the form for all the test codes.
If the test was not done due to disease, the record where FTTESTCD = "D4STR101" will have FTORRES and FTSTRESC equal to "No, Due to disease under study" and the test grade (FTTESTCD = "D4STR104") will be represented with a value of 1 = "Unable to walk independently".
- Some items on the 4-STAIR DESCEND may be logically skipped per the instrument instructions. If the test was not done because of disease, FTTESTCD = "D4STR102" and "D4STR103" are not done and are treated as logically skipped items. A record is created in ft.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:
FTSTAT = "NOT DONE"
FTREASND = "LOGICALLY SKIPPED ITEM"
FTORRES, FTSTRESC, and FTSTRESN are set to null
5. Terminology:FTCAT, FTTESTCD, and FTTEST values are included in CDISC Controlled Terminology.
A full list of value sets for result and units fields is provided in Section 4, SDTM Mapping Strategy.
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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 since because the subject was not able to do the 4-Stair stair descend. 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 | D4STR101 | D4STR1-Was 4-Stair Descend Performed | 4-STAIR DESCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 2 | STUDYX | FT | 1001-001 | 2 | D4STR102 | D4STR1-Time to Do 4-Stair Descend | 4-STAIR DESCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 3 | STUDYX | FT | 1001-001 | 3 | D4STR103 | D4STR1-Wear Orthoses | 4-STAIR DESCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 4 | STUDYX | FT | 1001-001 | 4 | D4STR104 | D4STR1-Test Grade | 4-STAIR DESCEND |
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| NOT DONE | REFUSED | Y | 1 | 2015-05-15 | | 5 | STUDYX | FT | 1001-002 | 1 | D4STR101 | D4STR1-Was 4-Stair Descend Performed | 4-STAIR DESCEND | 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 | D4STR102 | D4STR1-Time to Do 4-Stair Descend | 4-STAIR DESCEND |
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| NOT DONE | LOGICALLY SKIPPED ITEM | Y | 1 | 2015-05-15 | | 7 | STUDYX | FT | 1001-002 | 3 | D4STR103 | D4STR1-Wear Orthoses | 4-STAIR DESCEND |
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| NOT DONE | LOGICALLY SKIPPED ITEM | Y | 1 | 2015-05-15 | | 8 | STUDYX | FT | 1001-002 | 4 | D4STR104 | D4STR1-Test Grade | 4-STAIR DESCEND | Unable to descend 4 standard stairs. | 1 | 1 |
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| Y | 1 | 2015-05-15 | | 9 | STUDYX | FT | 1001-003 | 1 | D4STR101 | D4STR1-Was 4-Stair Descend Performed | 4-STAIR DESCEND | Yes | Y |
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| Y | 1 | 2015-05-15 | | 10 | STUDYX | FT | 1001-003 | 2 | D4STR102 | D4STR1-Time to Do 4-Stair Descend | 4-STAIR DESCEND | PT1M32S | PT1M32S |
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| Y | 1 | 2015-05-15 | | 11 | STUDYX | FT | 1001-003 | 3 | D4STR103 | D4STR1-Wear Orthoses | 4-STAIR DESCEND | No | N |
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| Y | 1 | 2015-05-15 | | 12 | STUDYX | FT | 1001-003 | 4 | D4STR104 | D4STR1-Test Grade | 4-STAIR DESCEND | Descends 4 standard stairs alternating feet, needs handrail for support. | 5 | 5 |
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| Y | 1 | 2015-05-15 | |
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