...

...

This document describes the CDISC implementation of the Brief Questionnaire of Smoking Urges instrument.

For CRFs that are created by CDISC with SME input, use this statement:  There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on input from PASI (TA or instrument) subject matter experts. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.) (the related reference article needs to be included as a footnote on the CDISC created CRF)

For CRFs that are created by CDISC based on articles, use this statement. Include the 1st sentence for articles that don't have a CRF.  If the 1st sentence is NOT included, then spell out "case report form (CRF)" in the 2nd sentence:  There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.  (note that if you use this statement, then QRS is not spelled out for the first time until where noted below.)CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

...

Stephen T Tiffanyowns the copyright for the QSU-BRIEF instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. (For supplements that are to be distributed by the copyright holder, add: Name of copyright holder (e.g., Board of Regents of The University of Texas System) will distribute the CDISC supplement package to sponsors when they are approved to use this instrument.) standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

...

• Cox, L. S., Tiffany, S. T., and Christen, A. G. Evaluation of the brief questionnaire of smoking urges (QSU-BRIEF) in laboratory and clinical settings. Nicotine and Tobacco Research, 3:7-16, 2001.
• Tiffany, S. T., and Drobes, D. J. The development and initial validation of a questionnaire on smoking urges. British Journal of Addition, 86:1467-1476, 1991.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

...

...