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Dataset wrap
Nameqs
Rowcaps
Row 2:Represent the missing data from the QSU-BRIEF Scale for subject 2324-P0001 at visit 1. Since the reason for not completing the visit was collected, the date is included in QSDTC for when the visit was planned. 
Rows 11-13:

Row 11 represents the subscale score for Factor 1 Scale, row 12 represents subscale score for Factor 2 Scale, and row 13 represents the General Factor Scale.

Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVINTX

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




NOT DONE

SUBJECT REFUSED

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

DURING QUESTIONNAIRE COMPLETION

12

STUDYX

QS

2324-P0001

12

QSUB0112

QSUB01-Factor 2 Scale

QSU-BRIEF

80

80

80



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

13

STUDYX

QS

2324-P0001

13

QSUB0113

QSUB01-General Factor Scale

QSU-BRIEF

68

68

68



Y

1

2015-05-15

DURING QUESTIONNAIRE COMPLETION

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Dataset wrap
Namesuppqs

The anchor range

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 text and numeric

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 values for data collection needs to be populated in SUPPQS

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dataset-wrapName

 as follows. The standard terminology for QNAM and QLABEL are listed below.

Dataset2
tableidsuppqs
STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
STUDYXQS2324-P0001QSTESTCDQSUB0106QSANTXLOAnchor Text LowStrongly DisagreeCRF
STUDYXQS2324-P0001QSTESTCDQSUB0110QSANTXHIAnchor Text HighStrongly AgreeCRF
STUDYXQS2324-P0001QSTESTCDQSUB0106QSANVLLOAnchor Numeric Value Low0CRF
STUDYXQS2324-P0001QSTESTCDQSUB0110QSANVLHIAnchor Numeric Value High100CRF

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 QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

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