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Title

Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)

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

MTWS-R

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 Tobacco Implementation Guide (TIG)), if applicable, and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0 (or higher as appropriate when doing a supplement revision)
StatusDRAFT (or "REVISION DRAFT" or "FINAL", as appropriate). Status will not be considered "Final" until the supplement is ready to be sent for publication.
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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© 2024 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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© 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) instrument.

There is no known standard case

1 Introduction

This document describes the CDISC implementation of the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) 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 MTWS-R (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. (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. 

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