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DateVersionSummary of Changes
2022-09-262.0 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 "LIFETIME"

b. Added annotations for QSSTRESC/QSSTRESN wherever applicable

  • Added the first assumption to include details on every item of the instrument.
  • The 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 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 "Most Recent Attempt", "Most Lethal Attempt" and "Initial/First Attempt" (QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B")  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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