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Title

Columbia-Suicide Severity Rating Scale Baseline Version 1/14/2009 (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 Version2.0
StatusREVISION DRAFT
Date2023-0102-2615
Notes
Known Issues
  • The concept of “conditional branching” in QRS instruments is when the instrument directs the subject to another item of the instrument based on the result of a response compare for a given condition. This concept was reviewed with the CDISC standards teams and it was agreed to use this term instead of “logically skipped item” moving forward for this QRS instrument use case. A new QRS variable named “QSCBRFL” with the description of “Conditional Branched Item Indicator” has been requested for release in SDTMIG v4.0. This new variable will streamline the data representation of conditional branched items.

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DateVersionSummary of Changes
2023-0102-26152.0 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)
  • 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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