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Title

Brief Questionnaire of Smoking Urges (QSU-Brief)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

QSU-Brief

QRS Permission StatusApproved (or 'Public Domain, Exempt from Copyright', as appropriate)
TeamStandards team QRS instrument is being developed for (e.g., Major Depressive Disorder Standards Team), if applicable, and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Dateyyyy-mm-dd (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.)
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.
  • This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. (COA #XXX, Qualified Clinical Outcome Assessments (COA) | FDA) (Use only for instruments this applies to; update COA #.)
Known IssuesOnly 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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This document describes the CDISC implementation of the Brief Questionnaire of Smoking Urges instrument.

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 expertspublished 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.) (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:  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.)

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

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