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| Title | Brief Questionnaire of Smoking Urges (QSU-BRIEF) |
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| CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Approved |
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| Team | Standards team QRS instrument is being developed for (e.g., Major Depressive Disorder Standards Team), if applicable, and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | DRAFT |
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| Date | 20232024-1201-3002 (date current version released, regardless of status - this date should always match the date in the Revision History section below and should be updated every time this supplement is edited.) |
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| Notes to Readers | - This supplement is available to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
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| Known Issues | Only include this row to describe any known issues related to the supplement. If there are no issues, this row can be deleted. |
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Revision History
| Date | Version |
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| 20232024-1201-3002 | 1.0 Draft |
© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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| 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 65: | Represent the missing datsa from the QSU-BRIEF Scale for subject 2324-P0001 at visit 2. Since the reason for not completing the visit was collected, the date is included in --DTC for when the visit was planned. As no observation is provided evaluation interval QSEVINTX is missing. NEED TO CHECK THIS. | 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. |
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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 | 50 | 50 | 50 |
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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 | 68 | 68 | 68 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETION | | 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.) |
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| | 65 | STUDYX | QS | 2324-P0001 | 1 | QSUB0101 | QSUB01-Desire Cigarette Right Now | QSU-BRIEF |
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| NOT DONE | SUBJECT REFUSED |
| 2 | 2015-05-15 |
DURING QUESTIONNAIRE COMPLETION |
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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 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. | Dataset wrap |
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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 | 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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4 SDTM Mapping Strategy
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| title | For public domain instrument's published QRS responses |
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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 QS"All QSTESTCDs" | QSORRES | QSSTRESC | QSSTRESN |
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| Original result 1Strongly Disagree | 0 | 0 | | Original result 21 | 1 | 1 | | Original result 32 | 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. | | 3 | 3 | 3 | | 4 | 4 | 4 | | 5 | 5 | 5 | | 6 | 6 | 6 | | 7 | 7 | 7 | | 8 | 8 | 8 | | 9 | 9 | 9 | | Strongly Agree | 10 | 10 |
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| Info |
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| title | For public domain instrument's published QRS responses |
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If this is a public domain |
| Info |
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| title | For public domain instrument's published QRS responses |
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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. |
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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"
QSTESTCD = "test code 27" QSTEST = "test name 27"
QSTESTCD = "test code 29" QSTEST = "test name 29"
| QSORRES | QSSTRESC | QSSTRESN |
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| Strongly Disagree | 0 | 0 |
| Strongly Agree | 100 | 100 |
| Info |
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| title | For public domain instrument's published QRS responses |
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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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| title | For public domain instrument's published QRS responses |
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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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For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows: QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence" |
| QSORRES | QSSTRESC | QSSTRESN |
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| I have not experienced the physical sensation of feeling weighted down and without physical energy | 0 | 0 |
| I have occasionally experienced periods of feeling physically weighted down and without physical energy, but without a negative effect on work, school, or activity level | 1 | 1 |
| I feel physically weighted down (without physical energy) more than half the time | 2 | 2 |
I feel physically weighted down (without physical energy) most of the time, several hours per day, several days per week | 3 | 3
5 Supplemental Qualifier Name Codes
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