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titleInformation for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Page properties
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 DRAFTFINAL
Date2023-02-1627
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.


Revision History

DateVersionSummary of Changes
2023-02-16272.0 Draft0 
  • Converted the supplement to the current WIKI QRS supplement template.
  • Annotated CRF updated to the Updated the annotated CRF per MSG V2.0 annotation guidelines, including following updates:
      a. Change of
        • Changing QSEVLINT to QSEVINTX for the Evaluation Interval Text of "LIFETIME"
      b. Added
        • 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), 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 text over 200 characters.
      • Added example for SUPPQS dataset.
      • Added section 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

    © 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

    1 Introduction

    This document describes the CDISC implementation of the Columbiathe Columbia-Suicide Severity Rating Scale Baseline Version 1/14/2009 (C-SSRS BASELINE) instrument.

    CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

    The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

    ...

    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.  

    2 Copyright Status

    The Research Foundation for Mental Hygiene, Inc. owns the copyright for the C-SSRS BASELINE instrument BASELINE instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. Hence Hence, CDISC developed QSTESTCD developed QSTESTCD and QSTEST for QSTEST for each item based on the actual text on the instrument.

    No part of the C-SSRS BASELINE Version 1/14/2009 may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of The Research Foundation for Mental Hygiene, Inc. and payment of any applicable fees. Copyright 2008 The Research Foundation for Mental Hygiene, Inc. All rights reserved.

    The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

    ...

    ...

    The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

    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.

    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 The Research Foundation for Mental Hygiene, Inc. for  for the approval to include the C-SSRS BASELINE in BASELINE in the CDISC data standards.

    Reference for the C-SSRS BASELINE:

    • (C-SSRS) Baseline 1/14/2009 (Posner, K.; Brent, D.; Lucas, C.; Gould, M.; Stanley, B.; Brown, G.; Fisher, P.; Zelazny, J.; Burke, A.; Oquendo, M.; Mann, J.; copyright 2008 The Research Foundation for Mental Hygiene, Inc.) 

    3 The QS Domain Model

    3.1 Assumptions for the QS Domain Model

    All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the Cthe C-SSRS BASELINE are listed below.

    The C-SSRS BASELINE is BASELINE is a suicidal ideation rating scale. It 's a is a standard questionnaire administered on a CRF that is typically used in clinical trials to identify subjects at risk for suicidal ideation and behavior. 

    1. The questionnaire is divided into 3 sections namely : Suicidal Ideation, Intensity of Ideation, and Suicidal Behavior.
      1. The first section, "SUICIDAL IDEATION"Suicidal Ideation, contains 5 items.
        1. QSTESTCD = "CSS0101" - "CSS0105" with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N".
          1. If QSORRES = "Yes", then descriptions provided for QSTESTCD = "CSS0101A" - "CSS0105A" are represented in QSORRES and QSSTRESC. QSSTRESN is null for these items.
      2. The second section "INTENSITY OF IDEATION" , Intensity of Ideation, contains 6 items.
        1. QSTESTCD = "CSS0106" is rating the most severe ideation with responses represented with a numeric score (1-5) in QSORRES, QSSTRESC, and QSSTRESN.
          1. "Description of Ideation" (QSTESTCD = "CSS0106A") is collected as free text. For  For this section of the C-SSRS BASELINE, QSORRES and QSSTRESC are represented with the text description. QSSTRESN is null for this item.
        2. For QSTESTCD = "CSS0107" - "CSS0108", the the scale points include a numeric rating (1-5) and a definition of what is represented by the rating (e.g., 1 = "Less than once a week"). QSORRES is populated with the text description while ; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.    
        3. For QSTESTCD = "CSS0109" - "CSS0111", the the scale points include a numeric rating (0-5) and a definition of what is represented by the rating (e.g., 0 = "Does not attempt to control thoughts"). QSORRES is populated with the text description while ; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
      3. The third section is "SUICIDAL BEHAVIOR".
        1. QSTESTCD = "CSS0112", "CSS0114", "CSS0115", "CSS0117", and "CSS0119" with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". QSSTRESN is null.
          1. If QSORRES = "Yes", then descriptions provided for QSTESTCD = "CSS0113A", "CSS0116A", "CSS0118A", and "CSS0119A" are represented in QSORRES and QSSTRESC. QSSTRESN is null for these items.
        2. For QSTESTCD = "CSS0120" QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". QSSTRESN is null for these items.
        3. A "Total # of Attempts" (QSTESTCD = "CSS0113"), "Total # of interrupted" (QSTESTCD = "CSS0116") and "Total # of aborted" (QSTESTCD = "CSS0118") is represented in QSORRES, QSSTRESC, and QSSTRESN.
        4. The section "Answer for Actual Attempts Only" contains the following:
          1. "Most Recent Attempt Date" (CSS0121A), "Most Lethal Attempt Date" (QSTESTCD = "CSS0122A"), and "Initial/First Attempt Date" (CSS0123A) are represented in QSORRES and QSSTRESC and should be in ISO 8601 format.
          2. "Actual Lethality/Medical Damage" for "Most Recent Attempt", "Most Lethal Attempt" and "Initial/First Attempt" (QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B") and "Potential Lethality" (QSTESTCD = "CSS0121C", "CSS0122C", and "CSS0123C") are represented with a numeric score (either "0-5" or "0-2", respectively) and descriptive text. For this section of the C-SSRS BASELINE, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
    2. The time period of evaluation for the C-SSRS BASELINE is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the C-SSRS BASELINE is "LIFETIME" (QSEVINTX = "LIFETIME").
    3. Items are divided into 3 subcategories represented in QSSCAT: "SUICIDAL IDEATION", "INTENSITY OF IDEATION" and "SUICIDAL BEHAVIOR".
    4. Some items on the C-SSRS BASELINE may be not done due to conditional branching. Items determined for conditional branching in the C-SSRS BASELINE are as follows:
      1. If QSTESTCD = "CSS0101" and "CSS0102" have QSORRES = "No", then the logic branches to QSTESTCD = "CSS0112" and QSTESTCD = "CSS0103" - "CSS010111" will not be done.
      2. If QSTESTCD = "CSS0101" has QSORRES ="Yes" and QSTESTCD = "CSS0102" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0106" and QSTESTCD = "CSS0103" - "CSS0105A" will not be done.
      3. Items QSTESTCD = "CSS0101A" - "CSS0105A" are only completed when the response to the preceding items (QSTESTCD = "CSS0101" - "CSS0105") is "Yes"; otherwise they are not done.
      4. If QSTESTCD = "CSS0112" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0114" and QSTESTCD = "CSS0113", "CSS0113A", "CSS0121A", "CSS0121B", "CSS0121C","CSS0122A", "CSS0122B", "CSS0122C", and"CSS0123A", "CSS0123B", "CSS0123C", will not be done.
      5. If QSTESTCD = "CSS0115" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0117" and QSTESTCD = "CSS0116" and "CSS0116A" will not be done.
      6. If QSTESTCD = "CSS0117" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0119" and QSTESTCD = "CSS0118" and "CSS0118A" will not be done.
      7. If QSTESTCD = "CSS0119" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0120" and QSTESTCD = "CSS0119A" will not be done.
      8. If QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B" have QSSTRESC = "1", "2", "3", "4", or "5", then QSTESTCD ="CSS0121C", "CSS0122C", and "CSS0123C" will not be done.

    5. A record is created and a QS supplemental qualifier variable is used to indicate an item was conditionally branched. When an item is not done due to conditional branching, it is represented as follows:

      1. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y”. (This is a QS supplemental qualifier variable.)      

      2. QSSTAT = "NOT DONE", and QSREASND is missing

      3. QSORRES, QSSTRESC and QSSTRESN are set to null (missing)
    6. Records are created in qs.xpt for every item on the sponsor's version of the instrument.
      1. For items not done due to conditional branching, refer to assumptions 4 and 5.
      2. In the unexpected situation where the reason is unknown, then QSORRES, QSSTRESC and QSSTRESN are all missing, QSSTAT = "NOT DONE", and QSREASND is missing.

    7. Some responses to the C-SSRS BASELINE items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit. 

    8. Terminology

      1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

      2. A full list of value sets for the qualifier, timing, and result fields is provided in Section 4, SDTM Mapping Strategy.

    ...