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Dataset wrap

Name	qs

Rowcaps

Rows 1-13:	Represent the questions from the QSU-Brief Scale for subject 2324-P0001 at visit 1. Row 11 represents the subscale total score for Factor 1, row 12 represents subscale total score for Factor 2 and row 13 represents the Overall Global Score.
Rows 15-16:	Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX".
Row 33:	The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	QSSEQ	QSTESTCD	QSTEST	QSCAT	QSORRES	QSSTRESC	QSSTRESN	QSLOBXFL	VISITNUM	QSDTC	QSEVINTX
1	STUDYX	QS	2324-P0001	1	QSUB0101	QSUB01-Desire Cigarette Right Now	QSU-BRIEF	90	90	90	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
2	STUDYX	QS	2324-P0001	2	QSUB0102	QSUB01-Nothing Better Than Cigarette Now	QSU-BRIEF	50	50	50	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
3	STUDYX	QS	2324-P0001	3	QSUB0103	QSUB01-Probably Would Smoke Now	QSU-BRIEF	70	70	70	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
4	STUDYX	QS	2324-P0001	4	QSUB0104	QSUB01-Control Things Better Could Smoke	QSU-BRIEF	70	70	70	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
5	STUDYX	QS	2324-P0001	5	QSUB0105	QSUB01-All I Want Right Now Is Cigarette	QSU-BRIEF	50	50	50	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
6	STUDYX	QS	2324-P0001	6	QSUB0106	QSUB01-Have an Urge for a Cigarette	QSU-BRIEF	Strongly Agree	100	100	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
7	STUDYX	QS	2324-P0001	7	QSUB0107	QSUB01-A Cigarette Would Taste Good Now	QSU-BRIEF	80	80	80	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
8	STUDYX	QS	2324-P0001	8	QSUB0108	QSUB01-Do Anything for a Cigarette Now	QSU-BRIEF	90	90	90	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
9	STUDYX	QS	2324-P0001	9	QSUB0109	QSUB01-Smoking Make Me Less Depressed	QSU-BRIEF	80	80	80	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
10	STUDYX	QS	2324-P0001	10	QSUB0110	QSUB01-Going Smoke as Soon as Possible	QSU-BRIEF	Strongly Disagree	0	0	Y	1	2015-05-15	DURING QUESTIONNAIRE COMPLETION
11	STUDYX	QS	2324-P0001	11	QSUB0111	QSUB01-Factor 1 Scale	QSU-BRIEF	68	68	68	Y	1	2015-05-15
12	STUDYX	QS	2324-P0001	12	QSUB0112	QSUB01-Factor 2 Scale	QSU-BRIEF	80	80	80	Y	1	2015-05-15
13	STUDYX	QS	2324-P0001	13	QSUB0113	QSUB01-General Factor Scale	QSU-BRIEF	68	68	68	Y	1	2015-05-15
Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.)
3365	STUDYX	QS	2324-P0001	331	IDSR131QSUB0101	IDSR1-Score	IDS-SR	18	18	18	Y	1	QSUB01-Desire Cigarette Right Now	QSU-BRIEF	2	2015-05-15	DURING QUESTIONNAIRE COMPLETION

Info

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

Dataset wrap

Name	suppqs

STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
STUDYX	QS	P0001	QSSEQ	Sequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8)	Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).	Label for QNAM (e.g., Contact Type)	Value of QNAM variable ( e.g., SUBJECT VISIT)	CRF

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Info

Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.

If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.

Some example mappings are below.

Info

title	For public domain instrument's published QRS responses

If this is a public domain instrument that has an individual item with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.
- The controlled response terminology for the tests below is named --TESTCDOR for the variable RSORRES and --TESTCDSTR for the variables RSSTRESN and RSSTTRESC.
If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.
- The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

QSSS0119

Info

If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

"All QSTESTCDs"

QSORRES	QSSTRESC	QSSTRESN
Original result 1	0	0
Original result 2	1	1
Original result 3	2	2

Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

QRS instruments with subcategories:

When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, items on the QRS Short_Name are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

QSSCAT

QSTESTCD

EMOTIONAL/INFORMATIONAL SUPPORT

QSSS0101 - QSSS0108

TANGIBLE SUPPORT

QSSS0109 - QSSS0112

AFFECTIONATE SUPPORT

QSSS0113 - QSSS0115

POSITIVE SOCIAL INTERACTION

QSSS0116 - QSSS0118

ADDITIONAL ITEM

Info

title	For public domain instrument's published QRS responses

If this is a public domain instrument

that has an individual item with published

with published QRS responses, include the following sentence above the—TESTCDs listed with their responses. This approach used the CDISC QRS CT instrument's SYNONYM as part of the codelist name.

The controlled response terminology for the tests below is named

--TESTCDOR

SYNONYMSET1OR for the variable RSORRES and

--TESTCDSTR

SYNONYMSET1STR for the variables RSSTRESN and RSSTTRESC.

If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

"All QSTESTCDs"

Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

Info
If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses. The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.
Info
QSORRES	QSSTRESC	QSSTRESN
Original result 1	0	0
Original result 2	1	1
Original result 3	2	2

Info

title	For public domain instrument's published QRS responses

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses. This approach used the CDISC QRS CT instrument's SYNONYM as part of the codelist name.

The controlled response terminology for the tests below is named SYNONYMSET1OR for the variable RSORRES and SYNONYMSET1STR for the variables RSSTRESN and RSSTTRESC.

Info

If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

QSTESTCD = "test code 1" QSTEST = "test name 1"

QSTESTCD = "test code 4" QSTEST = "test name 4"

QSTESTCD = "test code 5" QSTEST = "test name 5"

QSTESTCD = "test code 6" QSTEST = "test name 6"

QSTESTCD = "test code 7" QSTEST = "test name 7"

QSTESTCD = "test code 8" QSTEST = "test name 8"

QSTESTCD = "test code 15" QSTEST = "test name 15"

QSTESTCD = "test code 22" QSTEST = "test name 22"there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

QSTESTCD = "test code 271" QSTEST = "test name 271"

QSTESTCD = "test code 294" QSTEST = "test name 29"

QSORRES

QSSTRESC

QSSTRESN

I never take longer than 30 minutes to fall asleep

0

I take at least 30 minutes to fall asleep, less than half the time

1

I take at least 30 minutes to fall asleep, more than half the time

2

I take more than 60 minutes to fall asleep, more than half the time

3

Info

4"

QSTESTCD = "test code 5" QSTEST = "test name 5"

QSTESTCD = "test code 6" QSTEST = "test name 6"

QSTESTCD = "test code 7" QSTEST = "test name 7"

QSTESTCD = "test code 8" QSTEST = "test name 8"

QSTESTCD = "test code 15" QSTEST = "test name 15"

QSTESTCD = "test code 22" QSTEST = "test name 22"

QSTESTCD = "test code 27" QSTEST = "test name 27"Omit the QSSTRESN column when it is not applicable to the dataset.

QSTESTCD = "test code 29" QSTEST = "test name 29"

QSORRES	QSSTRESC
yes	Y
	QSSTRESN
Strongly Disagree	0	0
Strongly Agree	100	100	no	N

Info

title	For public domain instrument's published QRS responses

If this is a public domain instrument with published QRS responses, include the following sentence above the—TESTCDs listed with their responses.

- The controlled response terminology for the tests below is named --TESTCDTXXXOR for the variable RSORRES and --TESTCDTXXXTSTR for the variables RSSTRESN and RSSTTRESC.

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