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The QSU-BRIEF example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit and Visitnum VISITNUM = 2 for the QSU-BRIEF instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.
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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 VISITNUM = 2. Show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing
the questionnaire at the visit was not collected, and no date is assumed for when the visit would have occurred. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSMETHOD | 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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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 2 | STUDYX | QS | 2324-P0001 | 2 | QSUB0102 | QSUB01-Nothing Better Than Cigarette Now | QSU-BRIEF | 80 | 80 | 80 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 3 | STUDYX | QS | 2324-P0001 | 3 | QSUB0103 | QSUB01-Probably Would Smoke Now | QSU-BRIEF | 70 | 70 | 70 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 4 | STUDYX | QS | 2324-P0001 | 4 | QSUB0104 | QSUB01-Control Things Better Could Smoke | QSU-BRIEF | 70 | 70 | 70 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 5 | STUDYX | QS | 2324-P0001 | 5 | QSUB0105 | QSUB01-All I Want Right Now Is Cigarette | QSU-BRIEF | 50 | 50 | 50 |
Y |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 6 | STUDYX | QS | 2324-P0001 | 6 | QSUB0106 | QSUB01-Have an Urge for a Cigarette | QSU-BRIEF | Strongly Agree | 100 | 100 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 7 | STUDYX | QS | 2324-P0001 | 7 | QSUB0107 | QSUB01-A Cigarette Would Taste Good Now | QSU-BRIEF | 80 | 80 | 80 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 8 | STUDYX | QS | 2324-P0001 | 8 | QSUB0108 | QSUB01-Do Anything for a Cigarette Now | QSU-BRIEF | 90 | 90 | 90 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 9 | STUDYX | QS | 2324-P0001 | 9 | QSUB0109 | QSUB01-Smoking Make Me Less Depressed | QSU-BRIEF | 80 | 80 | 80 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 10 | STUDYX | QS | 2324-P0001 | 10 | QSUB0110 | QSUB01-Going Smoke as Soon as Possible | QSU-BRIEF | Strongly Disagree | 0 | 0 |
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| NUMERICAL RATING SCALE 11-POINT | Y | 1 | 2015-05-15 | RIGHT NOW | 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 | RIGHT NOW | 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 | RIGHT NOW | 13 | STUDYX | QS | 2324-P0001 | 13 | QSUB0113 | QSUB01-General Factor Scale | QSU-BRIEF | 71 | 71 | 71 |
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| Y | 1 | 2015-05-15 | RIGHT NOW | 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 |
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| 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 |
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| 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 |
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| NOT DONE |
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| 2 |
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| 19 | STUDYX | QS | 2324-P0001 | 19 | QSUB0106 | QSUB01-Have an Urge for a Cigarette | QSU-BRIEF |
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| 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 |
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| NOT DONE |
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| 2 |
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The The anchor range text text and numeric values values for data collection needs to be populated in SUPPQS as as follows. The standard terminology for QNAM example provided illustrates the potential response options for QSTESTCD = "QSUB0101" only, but this applies to all QSTESTCD. 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 | QSSEQQSTESTCD | 6QSUB0101 | QSANTXHIQSANTXLO | Anchor Text HighLow | Strongly AgreeDisagree | CRF | | STUDYX | QS | 2324-P0001 | QSSEQQSTESTCD | 6QSUB0101 | QSANVLHIQSANTXHI | Anchor Numeric Value Text High | 100Strongly Agree | CRF | | STUDYX | QS | 2324-P0001 | QSSEQQSTESTCD | 10QSUB0101 | QSANTXLOQSANVLLO | Anchor Text Numeric Value Low | Strongly Disagree0 | CRF | | STUDYX | QS | 2324-P0001 | QSSEQQSTESTCD | 10QSUB0101 | QSANVLLOQSANVLHI | Anchor Numeric Value LowHigh | 0100 | CRF |
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4 SDTM Mapping Strategy
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