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Title 4-Stair Descend (4-STAIR DESCEND) CDISC Reference Functional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials QRS Short Name 4-STAIR DESCEND QRS Permission Status Public Domain Team Duchenne Muscular Dystrophy (DMD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam Supplement Version 1.0 Status DRAFT Date 20222024-0602-0309 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

© 2022 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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 CDISC inventory of QRS data standards supplements. Hence, CDISC developed FTTESTCD and FTTEST for each item based on the actual text on the instrument 

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. 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.

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1. The numerical value for the time to complete the 4-STAIR DESCEND is recorded using 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")

2. For the test grade (where FTTESTCD = "D4STR104"), FTORRES is populated with the text description. The numeric rating is represented in FTSTRESC and FTSTRESN.

3. 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. 

   1. 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 independentlydescend 4 standard stairs."

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4. Some items on the 4-STAIR

   DESCEND

   ASCEND may be

   logically skipped

   conditionally branched 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

   conditionally branched items. A record is created in ft.xpt for all items. When an item is considered a

   logically skipped

   conditionally branched item, it is represented as follows:

   FTSTAT

   1. QNAM = "FTCBRFL", QLABEL = "

   NOT DONE"     

5. FTREASND = "LOGICALLY SKIPPED ITEM

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   "
   

1. Conditionally Branched Item Flag", QVAL = "Y" (this is a FT supplemental qualifier variable related to the record).
   

2. FTORRES, FTSTRESC, and FTSTRESN are set to null (missing).

5. Terminology:

1. FTCAT, FTTESTCD, and FTTEST values are included in CDISC Controlled Terminology.

2. A full list of value sets for result and units fields is provided in Section 4, SDTM Mapping Strategy.

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The 4-STAIR DESCEND example below shows the terminology used to implement the instrument in the FT domain. This example shows

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the data for 1 subject collected at the baseline visit for the 4-STAIR DESCEND instrument, and data for 1 subject 2 subjects who did not perform the test, 1 who refused and 1 who could not do the test because of disease progression. The example uses CDISC Controlled Terminology for FTTESTCD, FTTEST, FTORRESU, FTSTRESU,

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and FTCAT. All original results, matching the CRF item response text, are represented in FTORRES. This result is then represented as a standard numeric score in FTSTRESN and as a standard character representation in FTSTRESC.

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This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM FT domainFT domain. It also provides guidance on how the result and unit variables (FTORRES, FTSTRESC, FTSTRESN, FTORRESU, and FTSTRESU)

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 should be populated.

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