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Title

Rising From Floor (RISING FROM FLOOR)

CDISC Reference

Functional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

QRS Short Name

RISING FROM FLOOR

QRS Permission StatusPublic Domain
TeamDuchenne Muscular Dystrophy (DMD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2022-06-0315
NotesThis 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

DateVersion
2022-06-0315
1.0 Draft

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

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  1. The numerical value for the time to complete the RISING FROM FLOOR 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 "T1M10SPT1M10S")

  2. For the test grade (where FTTESTCD = "RISEF104"), 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 = "RISEF101" will have FTORRES and FTSTRESC equal to "No, Due to disease under study" and the test grade (FTTESTCD = "RISEF104") will be represented with a value of 1 = "Unable to walk independently".

  4. Some items on the RISING FROM FLOOR may be logically skipped per the instrument instructions. If the test was not done because of disease, FTTESTCD = "RISEF102" and "RISEF103" 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:

    1. FTSTAT = "NOT DONE"     

    2. FTREASND = "LOGICALLY SKIPPED ITEM"

    3. FTORRES, FTSTRESC, and FTSTRESN are set to null

  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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