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Green = Recent FDA Changes Pink = Instructional information for developers Blue = Text can change from supplement to supplement based on the instrument Black = Standard template language |
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title | Information for Reviewers |
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Text in black is part of the template used to create this document and is not revised under CDISC internal or public review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument. |
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Title | Questionnaire on Smoking Urges-Brief (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 | Tobacco Standards Teamand 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 | 2024-02-1925 |
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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
Revision History
Date | Version |
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2024-02-25 |
Date | Version |
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2024-02-19 | 1.0 Draft |
© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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The original scores include a numeric rating (0-100) in increments of 10, and a definition of what the ratings represent at the scale anchors (e.g., 0 = "Strongly Disagree" and 100 = "Strongly Agree"). For the QSU-BRIEF, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN.
The numeric rating scale used in the QSU-BRIEF includes text and numeric values as indicated in the SUPPQS domain with:
QNAM = "QSANTXLO" QNAM = "QSANTXHI"
QNAM = "QSANVLLO" QNAM = "QSANVLHI"
= "QSANTXHI"
QNAM = "QSANVLLO" QNAM = "QSANVLHI"
By storing this information in SUPPQS, it is available for interpretation purposes.- For questionnaire items QSTESTCD = "QSUB0101" to QSTESTCD ="QSUB0110", QSMETHOD is populated with "NUMERICAL RATING SCALE 11-POINT". The numeric rating scale represents the item-level ratings from 0 = "Strongly Disagree" to 100 = "Strongly Agree" in increments of 10By storing this information in SUPPQS, it is available for interpretation purposes.
- The time period of evaluation for the QSU-BRIEF is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the QSU-BRIEF is "DURING QUESTIONNAIRE COMPLETIONRIGHT NOW" (QSEVINTX = "DURING QUESTIONNAIRE COMPLETIONRIGHT NOW").
- Records are created in qs.xpt for every instrument item:
For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.
- Due to the variability of copyright holder and public domain derived subscore and overall score generation processes, records are not included for derived subscores or overall scores that are not provided.
The QSU-BRIEF instrument includes an overall score and two subscoresthat are considered as captured data on the instrument and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from Stephen T Tiffany.
- Subscores and overall scores are represented in QSORRES, QSSTRESC, and QSSTRESN.
- If subscores or overall scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible. It is the sponsors responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.
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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 2. Since the visit was missed, the reason for not completing the visit was not collected, and no date is assumed for when the visit would have occurred. |
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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 COMPLETIONRIGHT NOW | 2 | STUDYX | QS | 2324-P0001 | 2 | QSUB0102 | QSUB01-Nothing Better Than Cigarette Now | QSU-BRIEF | 80 | 80 | 80 |
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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETIONRIGHT NOW | 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 COMPLETIONRIGHT NOW | 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 COMPLETIONRIGHT NOW | 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 COMPLETIONRIGHT 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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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETIONRIGHT NOW | 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 COMPLETIONRIGHT NOW | 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 COMPLETIONRIGHT NOW | 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 COMPLETIONRIGHT 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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| Y | 1 | 2015-05-15 | DURING QUESTIONNAIRE COMPLETIONRIGHT 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 | DURING QUESTIONNAIRE COMPLETIONRIGHT 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 | DURING QUESTIONNAIRE COMPLETIONRIGHT 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 | DURING QUESTIONNAIRE COMPLETIONRIGHT 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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| 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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| 16 | STUDYX | QS | 2324-P0001 | 16 | QSUB0103 | QSUB01-Probably Would Smoke Now | QSU-BRIEF |
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| NOT DONE |
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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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| 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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| 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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| 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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| 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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| 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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| 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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| 24 | STUDYX | QS | 2324-P0001 | 24 | QSUB0111 | QSUB01-Factor 1 Scale | QSU-BRIEF |
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| NOT DONE |
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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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| 26 | STUDYX | QS | 2324-P0001 | 26 | QSUB0113 | QSUB01-General Factor Scale | QSU-BRIEF |
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| NOT DONE |
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