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Comment: update example and section 4

...

There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on input from Duchenne muscular dystrophy subject matter experts. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses (text and numeric) as described on the CRF.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Functional Tests (FT) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC questionnaires, ratings, and scales (QRS) documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

...

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

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the 4 STAIR DESCEND in the library of QRS data standards supplements. Hence, CDISC developed FTTESTCD and FTTEST for each item based on the actual text on the instrument. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

Reference for the 4 STAIR DESCEND: 

...

The table represents the items from the 4 STAIR DESCEND form. USUBJID = "1001-001" did not perform the test due to the use of a wheelchair; however, the grade and orthoses question are still completed. 

Dataset wrap
Nameft


Rowcaps


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 the subject was not able to do the 10-Meter Walk/Run. The test grade is shown on row 8.
Rows 9-12:Show a subject who was able to complete the test.



Dataset2


RowSTUDYIDDOMAINUSUBJIDFTSEQFTTESTCDFTTESTFTCATFTORRES
FTORRESU
FTSTRESCFTSTRESN
FTSTRESU
FTSTATFTREASNDFTLOBXFLVISITNUMFTDTC
1STUDYXFT1001-0011D4STR101D4STR1-Was 4-
Time to
Stair Descend
4 Stairs
Performed4 STAIR DESCEND


NOT DONE
WHEELCHAIR USE
REFUSEDY12015-05-15
2STUDYXFT1001-0012D4STR102D4STR1
-Test Grade
-Time to Do 4-Stair Descend4 STAIR DESCEND
Unable to descend 4 standard stairs.1



NOT DONEREFUSED
1
Y12015-05-15
3STUDYXFT1001-0013D4STR103D4STR1-Wear Orthoses4 STAIR DESCEND
No



NOT DONE
N
REFUSEDY12015-05-15
4STUDYXFT1001-0014D4STR104D4STR1-Test Grade4 STAIR DESCEND


NOT DONEREFUSEDY12015-05-15
5STUDYXFT1001-0021D4STR101D4STR1-Was 4-Stair Descend Performed4 STAIR DESCENDNo, Due to disease under studyNo, Due to disease under study


Y12015-05-15
6STUDYXFT1001-0022D4STR102D4STR1-Time to Do 4-Stair Descend
4 Stairs
4 STAIR DESCEND
13.2sec13.213.2



NOT DONELOGICALLY SKIPPED ITEMY12015-05-15
7STUDYXFT1001-0023D4STR103D4STR1-Wear Orthoses4 STAIR DESCEND


NOT DONELOGICALLY SKIPPED ITEM
sec
Y12015-05-15
5
8STUDYXFT1001-002
2
4
D4STR102
D4STR104D4STR1-Test Grade4 STAIR DESCEND
Descends 4 standard stairs “marking time” (descends 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
Unable to descend 4 standard stairs.11

Y12015-05-15
9STUDYXFT1001-0031D4STR101D4STR1-Was 4-Stair Descend Performed4 STAIR DESCENDYesY


Y12015-05-15
10STUDYXFT1001-0032D4STR102D4STR1-Time to Do 4-Stair Descend4 STAIR DESCENDPT1M32SPT1M32S
2



Y12015-05-15
6
11STUDYXFT1001-
002
0033D4STR103D4STR1-Wear Orthoses4 STAIR DESCENDNoN


Y12015-05-15
12STUDYXFT1001-0034D4STR104D4STR1-Test Grade4 STAIR DESCENDDescends 4 standard stairs alternating feet, needs handrail for support.55

Y12015-05-15




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 and unit variables (FTORRES, FTSTRESC, FTSTRESN, FTORRESU, and FTSTRESU) should be populated.

All responses for 4 STAIR DESCEND are numeric and units are predetermined for those result variables that have units. This section shows which units should be used for each FTTESTCD and FTTEST.

FTTESTCD = "D4STR101" FTTEST = "D4STR1-Was 4 Stair Descend Performed"

FTORRESFTSTRESC
YesY
No, Due to disease under studyNo, Due to disease under study


FTTESTCD = "D4STR103FTTESTCD = "D4STR101" FTTEST = "D4STR1-Time to Descend 4 Stairs"Wear Orthoses"

FTORRESFTSTRESC
Yes
Y
No
N
FTORRESUFTSTRESUsecsec


FTTESTCD = "D4STR102D4STR104" FTTEST = "D4STR1-Test Grade"

FTORRESFTSTRESCFTSTRESN
Unable to descend 4 standard stairs.11
Descends 4 standard stairs “marking time” (descends 1 foot at a time, with both feet on a step before moving to next step), using both arms on one or both handrails.22
Descends 4 standard stairs “marking time” (descends 1 foot at a time, with both feet on a step before moving to next step), using one arm on one handrail.33
Descends 4 standard stairs “marking time” (descends 1 foot at a time, with both feet on a step before moving to next step), not needing handrail.44

Descends 4 standard stairs alternating feet, needs handrail for support.

55
Descends 4 standard stairs alternating feet, not needing handrail support.66

FTTESTCD = "D4STR103" FTTEST = "D4STR1-Wear Orthoses"

N
FTORRESFTSTRESC
Yes
Y
No



End of Document