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DateVersionSummary of Changes
2021-09-221.3 Draft
    • Converted the supplement to the current WIKI QRS supplement template.
    • Annotated CRF updated to the MSG V2.0 annotation guidelines, including following updates:

    a. Change of QSEVLINT to QSEVINTX for the Evaluation Interval Text of "Since Last Visit"
    b. Added annotations for QSSTRESC/QSSTRESN wherever applicable

    • Added the first assumption to include details on every item of the instrument.
    • The QSEVAL and QSEVALID assumption and variables were removed from this supplement since it is not captured on the CRF and no assumptions are made on the potential values.
    • Added assumptions 4, 5 and 6 for conditional branching. The example was updated to include records for these items.
    • Added QSLOBXFL variable to the example to represent a baseline response for visit 1
    • Added example to represent skipped visit (visitnum = 2)
    • Added QSDRVFL variable to the example to represent items not done due to conditional branching.
    • Section 4 (SDTM mapping strategy): Added an additional column in the table for QSTESTCD = "CSS0222B" QSTEST = "CSS02-Most Lethal Attempt Damage" to indicate CRF Text over 200 characters
    • Added example for SUPPQS dataset
    • Added section 5 Supplemental Qualifier Name Codes.
2014-09-031.2

  • Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Revised:

    • Updated references to QSCAT and questionnaire name throughout the document.
    • Section 3.1: Assumption # 2 – Evaluation Interval mapped to QSEVINTX (from EVLINTTX).
    • Section 3.2: Updated text above example table. Example table updated to include QSEVINTX in the QS table. Removed the SUPPQS.xpt table.
    • Section 4: (SDTM Mapping Strategy) for QSTESTCD=CSS0111.

      Old value: Completely to end or stop pain
      New value: Completely to end or stop the pain
2013-02-061.1

Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Revised:

  • QSSCAT added to be compatible with all CSSR-S questionnaires
  • QSTPT replaced with QNAM=EVLINTTX to be compatible with all CSSR-S questionnaires using evaluation intervals
  • Corrected "Dose not apply", associated with the Most Severe Ideation, Reasons on page 9 to "Does not apply".
  • Added QS terminology reference
2012-08-071.0

Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Released

2012-03-030.1Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Draft

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Reference for the C-SSRS BASELINE:Kelly

  • (C-SSRS) Since Last Visit Version 1/14/2009 (Posner,

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  • K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.

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  • ; Brown, G.; Fisher, P.; Zelazny, J.; Burke, A.; Oquendo, M.; Mann, J.; copyright 2008 The Research Foundation for Mental Hygiene, Inc.

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Info

This is an example only.  Use the reference from the CDISC definition of the --CAT.

  • do not include the parentheses.
  • do not include copyright information from the definition about copyright holder and version since that's already included above.
  • do add a period to the end. 

If there are multiple references, please use the following format:

References for the QRS Short_Name:

  • CDISC Controlled Terminology reference.
  • additional reference.

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Notes on the use of quotation marks:

  • ) 
  • No part of the C-SSRS SINCE LAST VISIT Version 1/14/2009 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 The Research Foundation for Mental Hygiene, Inc. and payment of any applicable fees. Copyright 2008 The Research Foundation for Mental Hygiene, Inc. All rights reserved.

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3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

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