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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 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	2022-0506-2603
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
2022-0506-2603	1.0 Draft

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The numerical value for the time to complete the RISING FROM FLOOR 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 = "RISEF104"), 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.
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".
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
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.

3.2 Example for the RISING FROM FLOOR FT Domain Model

The RISING FROM FLOOR example below shows the terminology used to implement the instrument in the FT domain. This example shows the data for 1 subject collected at the baseline visit for the RISING FROM FLOOR instrument, and data for 1 subject who did not perform the test. The example uses CDISC Controlled Terminology for FTTESTCD, FTTEST, FTORRESU, FTSTRESU, 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.

The table represents items from the RISING FROM FLOOR form. USUBJID = "Subject 1001-001 " did not perform the test due to the use of a wheelchair; however, the grade and orthoses question are still filled out.

Dataset wrap

Name	ft

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

Dataset2

Row	STUDYID	DOMAIN	USUBJID	FTSEQ	FTTESTCD	FTTEST	FTCAT	FTORRES	FTSTRESC	FTSTRESN	FTSTAT	FTREASND	FTLOBXFL	VISITNUM	FTDTC
1	STUDYX	FT	1001-001	1	RISEF101	RISEF1-Was Rising From Floor Performed	RISING FROM FLOOR				NOT DONE	REFUSED	Y	1	2015-05-15
2	STUDYX	FT	1001-001	2	RISEF102	RISEF1-Time to Rise From Floor	RISING FROM FLOOR				NOT DONE	REFUSED	Y	1	2015-05-15
3	STUDYX	FT	1001-001	3	RISEF103	RISEF1-Wear Orthoses	RISING FROM FLOOR				NOT DONE	REFUSED	Y	1	2015-05-15
4	STUDYX	FT	1001-001	4	RISEF104	RISEF1-Test Grade	RISING FROM FLOOR				NOT DONE	REFUSED	Y	1	2015-05-15
5	STUDYX	FT	1001-002	1	RISEF101	RISEF1-Was Rising From Floor Performed	RISING FROM FLOOR	No, Due to disease under study	No, Due to disease under study				Y	1	2015-05-15
6	STUDYX	FT	1001-002	2	RISEF102	RISEF1-Time to Rise From Floor	RISING FROM FLOOR				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
7	STUDYX	FT	1001-002	3	RISEF103	RISEF1-Wear Orthoses	RISING FROM FLOOR				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
8	STUDYX	FT	1001-002	4	RISEF104	RISEF1-Test Grade	RISING FROM FLOOR	Unable to stand from supine, even with use of a chair.	1	1			Y	1	2015-05-15
9	STUDYX	FT	1001-003	1	RISEF101	RISEF1-Was Rising From Floor Performed	RISING FROM FLOOR	Yes	Y				Y	1	2015-05-15
10	STUDYX	FT	1001-003	2	RISEF102	RISEF1-Time to Rise From Floor	RISING FROM FLOOR	PT1M10S	PT1M10S				Y	1	2015-05-15
11	STUDYX	FT	1001-003	3	RISEF103	RISEF1-Wear Orthoses	RISING FROM FLOOR	No	N				Y	1	2015-05-15
12	STUDYX	FT	1001-003	4	RISEF104	RISEF1-Test Grade	RISING FROM FLOOR	Stands up without rolling over or using hands.	6	6			Y	1	2015-05-15

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3.2 Example for the RISING FROM FLOOR FT Domain Model