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DateVersionSummary of Changes
2021-09-222.0 Draft
  • Variable QNAM=EVLINTTX replaced by QSEVINTX = LIFETIME
2014-09-031.2
  • 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
  • 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 FinalInitial Version

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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) 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: Name of copyright holderKelly 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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Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

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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

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acknowledges Kelly Posner, Ph.D., New York State Psychiatric Institute, © 2008 The Research Foundation for Mental Hygiene, Inc. for the approval to include the QRS Short_Name in the CDISC data standards.

Reference for the C-SSRS BASELINE:

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