Date | Version | Summary of Changes |
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2023-02-27 | 2.0 | - Converted the supplement to the current WIKI QRS supplement template.
- Updated the annotated CRF per MSG V2.0 guidelines, including:
- Changing QSEVLINT to QSEVINTX for the Evaluation Interval Text of "LIFETIME"
- Adding 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).
- 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.
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2014-09-03 | 1.2 | 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
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2013-02-06 | 1.1 | 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
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2012-08-07 | 1.0 | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Released |
2012-03-03 | 0.1 | Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Draft |