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Title

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

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

C-SSRS BASELINE

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.3
StatusREVISION DRAFT
Date2021-09-22
Notes
  • This supplement is intended 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. (Use only for instruments this applies to.)



Revision History

DateVersionSummary of Changes
2021-09-221.3 Draft
  • Added conditionally described items to a skipped item when it does not apply
  • Variable QNAM=EVLINTTX replaced by QSEVINTX = LIFETIME.
  • QSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
  • Added QSLOBXFL variable to the example to represent a baseline response for visit 1.
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
  • "Dose not
apply”
  • apply", associated with the Most Severe Ideation, Reasons on page 9 to
“Does
  • "Does not
apply”
  • apply".
  • Added QS terminology reference
2012-08-071.0
FinalInitial Version

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

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

© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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: Kelly Posner, Ph.D., New York State Psychiatric Institute, © 2008 The Research Foundation for Mental Hygiene, Inc. (e.g., Board of Regents of The University of Texas System) PhD - Director, Center for Suicide Risk Assessment - Columbia University/New York State Psychiatric Institute owns the copyright for the C-SSRS BASELINE 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: Kelly Posner, Ph.D., New York State Psychiatric Institute, © 2008 The Research Foundation for Mental Hygiene, Inc. (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.

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CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges acknowledges Kelly Posner, Ph.D., PhD - Director, Center for Suicide Risk Assessment - Columbia University/New York State Psychiatric Institute, © 2008 The Research Foundation for Mental Hygiene, Inc. for  for the approval to include the C-SSRS BASELINE in the CDISC data standards.

Reference for the C-SSRS BASELINE:?????

Kelly Posner, Ph.D., New York State Psychiatric Institute, © 2008 The Research Foundation for Mental Hygiene, Inc.

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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