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CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments orimplement protocols. CDISC disclaims any liability for your use of this material.

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) owns the copyright for the QRS Short_Name 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.) 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. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the 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 Surveys, which are owned exclusively by QualityMetric Incorporated. No part of the SF Health Surveys 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 and payment of any applicable fees. Copyright QualityMetric Incorporated All rights reserved.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the MTWS-R in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.

Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R) (Hughes JR. Measurement of the effects of abstinence from tobacco. A qualitative review. Psychol Addict Behav 2007;21:127-137)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. Inc.

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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