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Rowcaps |
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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. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVINTX |
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1 | STUDYX | QS | 2324-P0001 | 1 | QSUB0101 | QSUB01-Desire Cigarette Right Now | QSU-BRIEF | 90 | 90 | 90 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | 2 | STUDYX | QS | 2324-P0001 | 2 | QSUB0102 | QSUB01-Nothing Better Than Cigarette Now | QSU-BRIEF |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | 11 | STUDYX | QS | 2324-P0001 | 11 | QSUB0111 | QSUB01-Factor 1 Scale | QSU-BRIEF | 68 | 68 | 68 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | 12 | STUDYX | QS | 2324-P0001 | 12 | QSUB0112 | QSUB01-Factor 2 Scale | QSU-BRIEF | 80 | 80 | 80 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | 13 | STUDYX | QS | 2324-P0001 | 13 | QSUB0113 | QSUB01-General Factor Scale | QSU-BRIEF | 68 | 68 | 68 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION |
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The anchor range |
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values for data collection needs to be populated in SUPPQS |
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as follows. The standard terminology for QNAM and QLABEL are listed below. |
dataset-wrap | Name | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
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STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0106 | QSANTXLO | Anchor Text Low | Strongly Disagree | CRF | STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0110 | QSANTXHI | Anchor Text High | Strongly Agree | CRF | STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0106 | QSANVLLO | Anchor Numeric Value Low | 0 | CRF | STUDYX | QS | 2324-P0001 | QSTESTCD | QSUB0110 | QSANVLHI | Anchor Numeric Value High | 100 | CRF
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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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