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| Dataset wrap |
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| Rowcaps |
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| 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. | | Rows 14-26: | Represent the missing data from the QSU-BRIEF Scale for subject 2324-P0001 at visit 2. Show the subject was not evaluated on this instrument at visit 12. Since the visit was missed, the reason for not completing
the visit was not collected, the and no date is included in QSDTC assumed for when the visit was plannedwould have occurred. | | 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 | 80 |
NOT DONESUBJECT REFUSED| 80 |
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| 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 |
68686871 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | 14 | STUDYX | QS | 2324-P0001 | 14 | QSUB0101 | QSUB01-Desire Cigarette Right Now | QSU-BRIEF |
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| NOT DONE |
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| 2 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | 15 | STUDYX | QS | 2324-P0001 | 15 | QSUB0102 | QSUB01-Nothing Better Than Cigarette Now | QSU-BRIEF |
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| NOT DONE |
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| 2 |
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| 16 | STUDYX | QS | 2324-P0001 | 16 | QSUB0103 | QSUB01-Probably Would Smoke Now | QSU-BRIEF |
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| NOT DONE |
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| 2 |
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| 17 | STUDYX | QS | 2324-P0001 | 17 | QSUB0104 | QSUB01-Control Things Better Could Smoke | QSU-BRIEF |
|
|
| NOT DONE |
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| 2 |
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| 18 | STUDYX | QS | 2324-P0001 | 18 | QSUB0105 | QSUB01-All I Want Right Now Is Cigarette | QSU-BRIEF |
|
|
| NOT DONE |
|
| 2 |
|
| 19 | STUDYX | QS | 2324-P0001 | 19 | QSUB0106 | QSUB01-Have an Urge for a Cigarette | QSU-BRIEF |
|
|
| NOT DONE |
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| 2 |
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| 20 | STUDYX | QS | 2324-P0001 | 20 | QSUB0107 | QSUB01-A Cigarette Would Taste Good Now | QSU-BRIEF |
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| NOT DONE |
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| 2 |
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| 21 | STUDYX | QS | 2324-P0001 | 21 | QSUB0108 | QSUB01-Do Anything for a Cigarette Now | QSU-BRIEF |
|
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| NOT DONE |
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| 2 |
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| 22 | STUDYX | QS | 2324-P0001 | 22 | QSUB0109 | QSUB01-Smoking Make Me Less Depressed | QSU-BRIEF |
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| NOT DONE |
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| 2 |
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| 23 | STUDYX | QS | 2324-P0001 | 23 | QSUB0110 | QSUB01-Going Smoke as Soon as Possible | QSU-BRIEF |
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| NOT DONE |
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| 2 |
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| 24 | STUDYX | QS | 2324-P0001 | 24 | QSUB0111 | QSUB01-Factor 1 Scale | QSU-BRIEF |
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| NOT DONE |
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| 2 |
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| 25 | STUDYX | QS | 2324-P0001 | 25 | QSUB0112 | QSUB01-Factor 2 Scale | QSU-BRIEF |
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| NOT DONE |
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| 2 |
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| 26 | STUDYX | QS | 2324-P0001 | 26 | QSUB0113 | QSUB01-General Factor Scale | QSU-BRIEF |
|
|
| NOT DONE |
|
| 2 |
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| Dataset wrap |
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The anchor range text and numeric values for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below. | Dataset2 |
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| | 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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