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Revision History

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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For the first version of a supplement, use the above Revision History table and delete this information box.

When a previously published supplement is being revised, a modified "Revision History" table will need to be used. Add a new column at the right called "Summary of Changes" if this is the first revision to the supplement (see table below). Also add a new row under the column headers with the current information, keeping all rows previously added. The bottom row should be for Version 1.0, with subsequent versions added above each of the previous rows.

If you are making changes to a supplement for the first time, put "Initial Final Version" in the Summary of Changes column for Version 1.0. Then add a row above with the new version number (1.1 if the changes are considered minor such as a typo, 2.0 if they are major such as variable changes) and summary of changes.

Revision History

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© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

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

1 Introduction

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

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

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Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.  (Include this line only for supplements that the US FDA will be reviewing.  Please DO NOT MODIFY the sentence.)

2 Copyright Status

For copyrighted instruments use the following text:  Name of copyright holder (e.g., Board of Regents of The University of Texas System) Stephen T Tiffanyowns the copyright for the QRS Short_Name 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  will distribute the CDISC supplement package to sponsors when they are approved to use this instrument.) Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.For public domain instruments use the following text: CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the QRS Short_Name in the CDISC inventory of QRS data standards supplements.when they are approved to use this instrument.) Hence, CDISC developed developed QSTESTCD and QSTEST QSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.

Insert the CDISC copyright or Exempt from Copyright CDISC text that is included in each of the –CAT CT CDISC Definition. This same text is annotated as a text box on the annotated CRF.

These materials discuss and/or include one or more of the SF Health Surveysthe Questionnaire on Smoking Urges-Brief (QSU-Brief), which are owned exclusively by QualityMetric IncorporatedStephen T Tiffany. No part of the SF Health Surveys Questionnaire on Smoking Urges-Brief (QSU-Brief) may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of QualityMetric Incorporated  Stephen T Tiffany and payment of any applicable fees. Copyright QualityMetric Incorporated All rights reserved.These materials discuss and/or include the Patient Health Questionnaire - 9 (PHQ-9) which is owned exclusively by the Pfizer. Inc. Use of the PHQ-9 is subject to Pfizer. Inc. terms of use. See (https://www.phqscreeners.com/select-screener). PHQ-9 copyright 2001, Pfizer. IncStephen T Tiffany. All rights reserved.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

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