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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.

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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 Version12.30
StatusREVISION DRAFTFINAL
Date20222023-0802-1127
Notes
  • This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.

Revision History

Known Issue
  • 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

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
    DateVersionSummary of Changes
    2023-02-272.0 
    • 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.
    2014-09-031.2
    DateVersionSummary of Changes
    2021-09-221.3 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 "Since Last Visit"
      b. Added annotations for QSSTRESC/QSSTRESN wherever applicable

      • Added the first assumption to include details on every item of the instrument.
      • The QSEVAL and QSEVALID assumption and variables were 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 QSTESTCD = "CSS0222B" QSTEST = "CSS02-Most Lethal Attempt Damage" to indicate CRF Text over 200 characters
      • Added example for SUPPQS dataset
      • Added section 5 Supplemental Qualifier Name Codes.
    2014-09-031.22013-02-061.1

    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
    • 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
    2013-02-061.12012-08-071.0

    Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) ReleasedRevised:

    • 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

    2012-03-032012-03-030.1Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE) Draft

    © 2021 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.

    ...

    The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

    1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

    This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

    ...

    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. 

    Info
    titleInformation for Reviewers

    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 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) Since Last Visit Version 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.) 
    • No part of the C-SSRS SINCE LAST VISIT 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.

    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 C-SSRS BASELINE are listed below.

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

    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 C-SSRS BASELINE are listed below.

    The C-SSRS BASELINE is a suicidal ideation rating scale. It 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: Suicidal Ideation, Intensity of Ideation, and Suicidal Behavior.
      1. The first section, 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, 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 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 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; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.  
        3. For QSTESTCD = "CSS0109" - "CSS0111", 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;
      The questionnaire is divided into 3 sections namely Suicidal Ideation, Intensity of Ideation and Suicidal Behavior.
      1. The first section, "Suicidal Ideation", contains 5 items (QSTESTCD = "CSS0201" - "CSS0205") with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". If QSORRES = "Yes", then descriptions are represented in items QSTESTCD = "CSS0201A" - "CSS0205A". QSSTRESN is null for these items.
      2. The second section "Intensity of Ideation" contains 6 items (QSTESTCD = "CSS0206" - "CSS0211") rating the most severe ideation with responses represented with a numeric score  (either "0-5" or "1-5") and associated descriptive text. If "Most Severe Ideation" (QSTESTCD = "CSS0206") is present, "Description of Ideation" (QSTESTCD = "CSS0206A") is collected as free text. For this section of the C-SSRS SINCE LAST VISIT, QSORRES is populated with the text description while
        1. the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
      3. The third section, " Suicidal Behavior" , contains 7 items (.
        1. QSTESTCD = "
        CSS0212
        1. CSS0112", "
        CSS0214
        1. CSS0114", "
        CSS0215
        1. CSS0115", "
        CSS0217
        1. CSS0117", and "
        CSS0219" - "CSS0221
        1. CSS0119"
        )
        1. with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N".
        If
        1. 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 = "
        CSS0213A
        1. CSS0120"
        ,
        1. QSORRES = "
        CSS0216A
        1. Yes"
        ,
        1. or "
        CSS0218A
        1. No" and
        "CSS0219A
        1. QSSTRESC = "Y" or "N".
        QSSTRESN
        1.  QSSTRESN is null for these items.
        A
        1. "Total # of Attempts" (QSTESTCD = "
        CSS0213
        1. CSS0113"), "Total # of interrupted" (QSTESTCD = "
        CSS0216
        1. CSS0116") and "Total # of aborted" (QSTESTCD = "
        CSS0218
        1. CSS0118") is
        collected
        1. represented in QSORRES
        1. , QSSTRESC, and QSSTRESN.
        2. The section "Answer for Actual Attempts Only" contains
        "most lethal attempt date
        1. the following:
          1. "Most Recent Attempt Date" (CSS0121A), "Most Lethal Attempt Date" (QSTESTCD = "
        CSS0222A") collected in QSORRES.
          1. 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 =
        "CSS0222B
          1. "CSS0121B", "CSS0122B", and "CSS0123B"), and "Potential Lethality" (QSTESTCD = "
        CSS0222C
          1. 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
        SINCE LAST VISIT
          1. BASELINE, QSORRES is populated with the text description
        while
          1. ; 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 SINCE LAST VISIT is BASELINE is populated in the QSEVINTX field 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 SINCE LAST VISIT BASELINE is "SINCE LAST VISITLIFETIME" (QSEVINTX = "SINCE LAST VISITLIFETIME").
    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 SINCE LAST VISIT BASELINE may be not done due to conditional branching. Items determined for conditional branching in the Cthe C-SSRS SINCE LAST VIST BASELINE are as follows:
      1. If QSTESTCD = "CSS0201CSS0101" and "CSS0202" have QSORRES = "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   = "CSS0212CSS0106" and QSTESTCD = "CSS0203CSS0103" - "CSS0211CSS0105A" will not be done.
      3. Items QSTESTCD = "CSS0201ACSS0101A" - "CSS0205ACSS0105A" are only completed when the response to the preceding items (QSTESTCD = "CSS0201CSS0101" - "CSS0205CSS0105") is "Yes"; otherwise they are not done.
      4. If QSTESTCD = "CSS0212CSS0112" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0214CSS0114" and QSTESTCD = "CSS0213CSS0113", "CSS0213ACSS0113A", "CSS0222ACSS0121A", "CSS0121B"CSS0222B, " and CSS0121C"CSS0222C" will not , "CSS0122A", "CSS0122B", "CSS0122C", and "CSS0123A", "CSS0123B", "CSS0123C", will not be done.
      5. If QSTESTCD = "CSS0215CSS0115" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0217CSS0117" and QSTESTCD = "CSS0216CSS0116", and "CSS0216ACSS0116A" will not be done.
      6. If QSTESTCD = "CSS0217CSS0117" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0219CSS0119" and QSTESTCD = "CSS0218CSS0118", and "CSS0218ACSS0118A" will not be done.
      7. If QSTESTCD = "CSS0219CSS0119" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0220CSS0120", and QSTESTCD = "CSS0219ACSS0119A" will not be done.
      8. If QSTESTCD = "CSS0222B" has QSORRES "CSS0121B", "CSS0122B", and "CSS0123B" have QSSTRESC = "1", "2", "3", "4", or "5", then QSTESTCD = "CSS0222C"CSS0121C", "CSS0122C", and "CSS0123C" will not be done.
    5. A derived record is created and a QS supplemental qualifier variable is used to indicate an item was conditionally branched. When  When an item is not done due to conditional branching, it is represented as follows:

      1. QSDRVFL = "Y".

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

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

      4. 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 SINCE LAST VISITBASELINE 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 QSTEST values are included in CDISC Controlled Terminology.

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

    3.2 Example for the C-SSRS BASELINE QS Domain Model

    The CThe C-SSRS BASELINE example below shows the terminology used to implement the instrument in the QS domainthe QS domain. This example shows the data for 1 subject collected at the baseline visit and baseline (v1) and another subject at baseline (v1) and visit 2 for the C2 for the C-SSRS BASELINE instrumentBASELINE instrument. The example uses CDISC Controlled Terminology for QSTESTCDfor QSTESTCD, QSTEST, and QSCAT. All  All original results, matching the CRF item response text, are represented in QSORRES. This in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and in QSSTRESN and as a standard character representation in QSSTRESC. When in QSSTRESC. When a result is character only, the result is transformed into the standard character representation in QSSTRESC and QSSTRESN is null.

    The table represents the items from the C-SSRS BASELINE instrument.

    ...

    Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.

    For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:

    ...

    When the reason is collected for a not done visit, information or a row description should be added as follows:

    BASELINE instrument.

    Dataset wrap
    Nameqs
    Dataset wrap
    Nameqs

    qs.xpt

    Rows 5-6:Represent the conditional branching on data entry where Suicidal Ideation-No Intent is "No" and the associated description is missing.
    Rows 9-10:Represent the conditional branching on data entry where Ideation With Plan/Intent is "No" and the associated description is missing.
    Rows 28-29:Represent the conditional branching on data entry where Preparatory Acts/Behavior is "No" and the associated description is missing.
    Rows 32-33:Represent the conditional branching on data entry where Most Recent Attempt Damage is "3" and Most Recent Attempt Potential is missing.
    Rows 35-36:Represent the conditional branching on data entry where Most Lethal Attempt Damage is "4" and Most Lethal Attempt Potential is missing.
    Rows 40-56:Represents items missing due to conditional branching from the items Wish to be Dead and Non-Specific Suicidal Thought being "No".
    Rows 57-59:Represent the conditional branching on data entry where Actual Attempt is "No". The Number of Actual Attempts and the associated description are missing.
    Rows 61-63:Represent the conditional branching on data entry where Interrupted Attempt is "No". The Number of Interrupted Attempts and the associated description are missing.
    Rows 64-66:Represent the conditional branching on data entry where Aborted Attempt is "No". The Number of Aborted Attempt and the associated description are missing.
    Rows 70-78:Represents items missing due to conditional branching from Actual Attempt being "No".
    Rows 79-117:

    Show the subject was not evaluated on this instrument at visit 2. A record for each item on the instrument is created with a status of "NOT DONE". Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. 

    Dataset2
    ROW

    ...

    The suppqs dataset shows the items in the qs dataset which have assigned responses (QSDRVFL = "Y") due to conditional branching.

    ...

    The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

    Text that would remain unchanged has been left in black:

    The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

    Dataset wrap
    Nameqs
    Rowcaps
    Rows 13-14:Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX".
    Rows 15-16:Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX".
    Row 33:The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF.
    Dataset2
    RowQSEVLINT
    STUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVINTX
    1STUDYXQS2324-P00011IDSR101CSS0101IDSR1-Falling AsleepIDS-SRI never take longer than 30 minutes to fall asleep0CSS01-Wish to be DeadC-SSRS BASELINESUICIDAL IDEATIONYesY0


    Y120152022-0508-1519-P7DLIFETIME
    2STUDYXQS2324-P00012IDSR102CSS0101AIDSR1-Sleep During the NightIDS-SRCSS01-Wish to be Dead, DescribeC-SSRS BASELINESUICIDAL IDEATIONFall asleep and I do not wake up at night0Fall asleep and not wake up0


    Y120152022-0508-1519-P7DLIFETIME
    3STUDYXQS2324-P00013IDSR103CSS0102IDSR1-Waking Up Too EarlyIDS-SRMost of the time, I awaken no more than 30 minutes before I need to get up0CSS01-Non-Specific Suicidal ThoughtC-SSRS BASELINESUICIDAL IDEATIONYesY0


    Y120152022-0508-1519-P7DLIFETIME
    4STUDYXQS2324-P00014IDSR104CSS0102AIDSR1-Sleeping Too MuchIDS-SRI sleep no longer than 7-8 hours/night, without napping during the day0CSS01-Non-Specific Suicid Thought, DescrC-SSRS BASELINESUICIDAL IDEATIONI thought about taking an overdose but I never made a specific plan as to whenI thought about taking an overdose but I never made a specific plan as to when0


    Y120152022-0508-1519-P7DLIFETIME
    5STUDYXQS2324-P00015IDSR105IDSR1-Feeling SadIDS-SRI feel sad less than half the time1CSS0103CSS01-Suicidal Ideation-No IntentC-SSRS BASELINESUICIDAL IDEATIONNoN1


    Y120152022-0508-1519-P7DLIFETIME
    6STUDYXQS2324-P00016IDSR106CSS0103AIDSR1- Feeling IrritableIDS-SRI feel irritable less than half the time11Y12015-05-15CSS01-Suicidal Ideation-No Intent, DescrC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    12022-08-19LIFETIME-P7D
    7STUDYXQS2324-P00017IDSR107CSS0104IDSR1-Feeling Anxious or TenseIDS-SRI feel anxious (tense) less than half the time1CSS01-Ideation With Intent, No PlanC-SSRS BASELINESUICIDAL IDEATIONYesY1


    Y120152022-0508-1519-P7DLIFETIME
    8STUDYXQS2324-P00018IDSR108CSS0104AIDSR1-Your Mood to Good/Desired EventsIDS-SRMy mood brightens but I do not feel like my normal self when good events occur1CSS01-Ideation With Intent No Plan DescrC-SSRS BASELINESUICIDAL IDEATIONI’ve thought about killing myself and howI’ve thought about killing myself and how1


    Y120152022-0508-1519-P7DLIFETIME
    9STUDYXQS2324-P00019IDSR109CSS0105IDSR1-Mood in Relation to Time of DayIDS-SRMy mood often relates to the time of day because of environmental events (e.g., being alone, working)1CSS01-Ideation With Plan/IntentC-SSRS BASELINESUICIDAL IDEATIONNoN1


    Y120152022-0508-1519-P7DLIFETIME
    10STUDYXQS2324-P000110IDSR109ACSS0105AIDSR1-Mood Worse Morn/Afternoon/NightIDS-SRAfternoonAfternoonY12015-05-15-P7DCSS01-Ideation With Plan/Intent, DescrC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    12022-08-19LIFETIME
    11Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.)33STUDYXQS2324-P00013311IDSR131CSS0106IDSR1CSS01-ScoreMost Severe IdeationIDS-SR1818C-SSRS BASELINEINTENSITY OF IDEATION11118

    Y12015-05-15
    Info
    Dataset wrap
    Namesuppqs
    STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
    STUDYXQSP0001QSSEQSequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8)Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).Label for QNAM (e.g., Contact Type)Value of QNAM variable ( e.g., SUBJECT VISIT)CRF

    4 SDTM Mapping Strategy

    This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

    Info

    Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.

    If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.

    Some example mappings are below.

    ...

    For QRS instruments with subcategories:

    When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

    QSSCAT alignment with QSTESTCD

    As stated in Section 3.1 assumptions, items on the QRS Short_Name are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

    ...

    If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

    "All QSTESTCDs"

    ...

    Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

    ...

    If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

    QSTESTCD = "test code 1" QSTEST = "test name 1"

    QSTESTCD = "test code 4" QSTEST = "test name 4"

    QSTESTCD = "test code 5" QSTEST = "test name 5"

    QSTESTCD = "test code 6" QSTEST = "test name 6"

    QSTESTCD = "test code 7" QSTEST = "test name 7"

    QSTESTCD = "test code 8" QSTEST = "test name 8"

    QSTESTCD = "test code 15" QSTEST = "test name 15"

    QSTESTCD = "test code 22" QSTEST = "test name 22"

    QSTESTCD = "test code 27" QSTEST = "test name 27"

    QSTESTCD = "test code 29" QSTEST = "test name 29"

    ...

    Omit the QSSTRESN column when it is not applicable to the dataset.

    QSTESTCD = "test code" QSTEST = "test name"

    ...

    For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

    QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

    QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

    ...

    5 Supplemental Qualifier Name Codes

    Info

    The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

    Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

    Remove Section 5 if it does not apply to the new instrument.

    The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

    ...

    Namesuppqs

    ...

    End of Document

    ...

    titleInstructions on how to use this template

    ...

    1. Remove 'Copy of QRS Supplement Template - '.
    2. Replace 'Name of QRS Instrument' with the full name of the QRS instrument the supplement is being created for.
    3. Change 'QRS Short_Name' to the short name (--CAT) for the current instrument.

    ...

    1. The supplement version number will be 'v1' if there has never been a supplement for the instrument before. Otherwise, increment as appropriate.
    2. If the CRF was copyright approved, keep 'Approved'; otherwise change 'Approved' to 'Public Domain'.

    ...

    • Numbers that begin a sentence, title, subtitle, or heading 
    • Common fractions 

    • Accepted usage such as idiomatic expressions and numbers used as pronouns 

    • Other uses of “one” in running text (e.g., when meaning "a")
    • Ordinals first through ninth
    • Numbers spelled out in quotes or published titles.
    Info
    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.

    ...

    Columbia-Suicide Severity Rating Scale Baseline (C-SSRS BASELINE)

    ...

    C-SSRS BASELINE

    ...

    • This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
    • This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. (Use only for instruments this applies to.)

    Revision History

    ...

    • Variable QNAM=EVLINTTX replaced by QSEVINTX = LIFETIME.
    • 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 QSLOBXFL variable to the example to represent a baseline response for visit 1.

    ...

    • 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

    ...

    • 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

    ...

    © 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

    1 Introduction

    This document describes the CDISC implementation of the Columbia-Suicide Severity Rating Scale Baseline (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.

    These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

    The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

    1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

    This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

    CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

    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.  (Include this line only for supplements that the US FDA will be reviewing.  Please DO NOT MODIFY the sentence.)

    2 Copyright Status

    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: 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) 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.

    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. 

    Info
    titleInformation for Reviewers

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

    Reference for the C-SSRS BASELINE:

    ?????

    Info

    This is an example only.  Use the reference from the CDISC definition of the --CAT.

    • do not include the parentheses.
    • do not include copyright information from the definition about copyright holder and version since that's already included above.
    • do add a period to the end. 

    If there are multiple references, please use the following format:

    References for the QRS Short_Name:

    • CDISC Controlled Terminology reference.
    • additional reference.
    Info

    Notes on the use of quotation marks:

    • Use for text values of a Likert scale: e.g., ...with response options ranging from “never” to “daily."
    • Actual numbers of the scale (e.g., 0-3) do not appear in quotation marks while the definitions of these anchors (e.g., 5 = “I always fall asleep”) do.
    • Enclose values for variables within quotation marks (e.g., QSTESTCD = "IPA0102")

    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 C-SSRS BASELINE are listed below.

    The C-SSRS BASELINE is a multiple-choice instrument that clinicians may use to assess the severity of depressive symptoms. It consists of 30 items, each rated on a 4-point scale. A total score between 0-84 is also captured.

    ...

    Include a description of scale score or other possible responses (You may need multiple numbered points for this, tho the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleep"). For the QRS Short_Name, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. (replace this sentence for instruments with text only responses with “QSORRES and QSSTRESC are populated with the text description and QSSTRESN is not represented with a numeric value”.

    ...

    Records are created in qs.xpt for every item on the instrument

    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE".  If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "LOGICALLY SKIPPED ITEM" or QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

    ...

    If the instrument standards currently being developed includes logically skipped items, insert:  Some items on the QRS Short_Name may be logically skipped per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a logically skipped item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min). A record is created in rs.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:

    1. RSSTAT = "NOT DONE".       

    2. RSREASND = "LOGICALLY SKIPPED ITEM".

    3. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).

    ...

    Include this point if score(s) are submitted to SDTM. Update blue text: The QRS Short_Name instrument includes a total score (and other scores as needed.  If so, change "that is" to "that are") that is considered as captured data on the CRF and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].

    1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

    2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.

    ...

    This language is currently under review. Evaluator information is only to be included when the information is collected directly on the CRF. instruments will no longer be using QSEVAL/QSEVALID; however RSEVAL/RSEVALID and FTEVAL/FTEVALID will continue to be used on Clinical Classifications and Functional Tests. Language for Clinical Classifications and Functional tests follows; language for instruments is currently under review. Remove this point if it does not apply.

    For Clinical Classifications and Functional Tests (only when collected on the CRF):  *** This section to be updated.  QSEVAL/ID, FTEVAL/ID, and RSEVAL/ID will no longer be used.  Supplemental qualifiers will represent this information. *** For QRS Short_Name, the evaluator is defined as the (the appropriate term from controlled terminology). Alternatively, if only evaluator name or initials could be collected: For QRS Short_Name, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. CDISC Controlled Terminology is available for Evaluator (e.g., --EVAL = "HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., --EVALID = "RATER 1"). To reiterate, only include this point if the evaluator/administrator is collected directly on the CRF.

    ...

    Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the QRS Short_Name will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

    ...

    Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the QRS Short_Name 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.

    ...

    Terminology

    1. QSCAT, QSTESTCD, and QSTEST (and other variables such as QSORRESU as needed) values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, resultand unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

    3.2 Example for the QRS Short_Name QS Domain Model

    The QRS Short_Name example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the QRS Short_Name instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. When there are numeric results, then use this sentence next, "This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC." When the results are character only, then use these sentences next, "This result is then transformed into the standard character representation in QSSTRESCQSSTRESN is null as there are no standardized numeric results for this instrument."

    ...

    Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.

    For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:

    ...

    When the reason is collected for a not done visit, information or a row description should be added as follows:

    ...

    Info

    We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

    ...

    Nameqs

    ...

    The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

    Text that would remain unchanged has been left in black:

    The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

    ...

    Namesuppqs

    ...

    4 SDTM Mapping Strategy

    This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

    Info

    Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.

    If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.

    Some example mappings are below.

    ...

    For QRS instruments with subcategories:

    When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

    QSSCAT alignment with QSTESTCD

    As stated in Section 3.1 assumptions, items on the QRS Short_Name are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

    ...

    If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

    "All QSTESTCDs"

    ...

    Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

    ...

    2022-08-19LIFETIME
    12STUDYXQS2324-P000112CSS0106ACSS01-Most Severe Ideation, DescriptionC-SSRS BASELINEINTENSITY OF IDEATIONWish to be DeadWish to be Dead


    Y12022-08-19LIFETIME
    13STUDYXQS2324-P000113CSS0107CSS01-Most Severe Ideation, FrequencyC-SSRS BASELINEINTENSITY OF IDEATIONOnce a week22

    Y12022-08-19LIFETIME
    14STUDYXQS2324-P000114CSS0108CSS01-Most Severe Ideation, DurationC-SSRS BASELINEINTENSITY OF IDEATION4-8 hours/most of day44

    Y12022-08-19LIFETIME
    15STUDYXQS2324-P000115CSS0109CSS01-Most Severe Ideation, ControlC-SSRS BASELINEINTENSITY OF IDEATIONDoes not attempt to control thoughts00

    Y12022-08-19LIFETIME
    16STUDYXQS2324-P000116CSS0110CSS01-Most Severe Ideation, DeterrentsC-SSRS BASELINEINTENSITY OF IDEATIONDoes not apply00

    Y12022-08-19LIFETIME
    17STUDYXQS2324-P000117CSS0111CSS01-Most Severe Ideation, ReasonsC-SSRS BASELINEINTENSITY OF IDEATIONMostly to get attention, revenge or a reaction from others22

    Y12022-08-19LIFETIME
    18STUDYXQS2324-P000118CSS0112CSS01-Actual AttemptC-SSRS BASELINESUICIDAL BEHAVIORYesY


    Y12022-08-19LIFETIME
    19STUDYXQS2324-P000119CSS0113CSS01-Number of Actual AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR555

    Y12022-08-19LIFETIME
    20STUDYXQS2324-P000120CSS0113ACSS01-Actual Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIORTo feel betterTo feel better


    Y12022-08-19LIFETIME
    21STUDYXQS2324-P000121CSS0114CSS01-Non-suicidal Self-injurious BehavC-SSRS BASELINESUICIDAL BEHAVIORNoN


    Y12022-08-19LIFETIME
    22STUDYXQS2324-P000122CSS0115CSS01-Interrupted AttemptC-SSRS BASELINESUICIDAL BEHAVIORYesY


    Y12022-08-19LIFETIME
    23STUDYXQS2324-P000123CSS0116CSS01-Number of Interrupted AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR111

    Y12022-08-19LIFETIME
    24STUDYXQS2324-P000124CSS0116ACSS01-Interrupted Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIORStopped from overdoseStopped from overdose


    Y12022-08-19LIFETIME
    25STUDYXQS2324-P000125CSS0117CSS01-Aborted AttemptC-SSRS BASELINESUICIDAL BEHAVIORYesY


    Y12022-08-19LIFETIME
    26STUDYXQS2324-P000126CSS0118CSS01-Number of Aborted AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR333

    Y12022-08-19LIFETIME
    27STUDYXQS2324-P000127CSS0118ACSS01-Aborted Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIORParent found my lettersParent found my letters


    Y12022-08-19LIFETIME
    28STUDYXQS2324-P000128CSS0119CSS01-Preparatory Acts/BehaviorC-SSRS BASELINESUICIDAL BEHAVIORNoN


    Y12022-08-19LIFETIME
    29STUDYXQS2324-P000129CSS0119ACSS01-Preparatory Acts/Behavior, DescrC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-08-19LIFETIME
    30STUDYXQS2324-P000130CSS0120CSS01-Suicidal BehaviorC-SSRS BASELINESUICIDAL BEHAVIORYesY


    Y12022-08-19LIFETIME
    31STUDYXQS2324-P000131CSS0121ACSS01-Most Recent Attempt DateC-SSRS BASELINESUICIDAL BEHAVIOR2022-07-172022-07-17


    Y12022-08-19LIFETIME
    32STUDYXQS2324-P000132CSS0121BCSS01-Most Recent Attempt DamageC-SSRS BASELINESUICIDAL BEHAVIORModerately severe physical damage; medical hospitalization and likely intensive care required33

    Y12022-08-19LIFETIME
    33STUDYXQS2324-P000133CSS0121CCSS01-Most Recent Attempt PotentialC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-08-19LIFETIME
    34STUDYXQS2324-P000134CSS0122ACSS01-Most Lethal Attempt DateC-SSRS BASELINESUICIDAL BEHAVIOR2021-12-242021-12-24


    Y12022-08-19LIFETIME
    35STUDYXQS2324-P000135CSS0122BCSS01-Most Lethal Attempt DamageC-SSRS BASELINESUICIDAL BEHAVIORSevere physical damage; medical hospitalization with intensive care required44

    Y12022-08-19LIFETIME
    36STUDYXQS2324-P000136CSS0122CCSS01-Most Lethal Attempt PotentialC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-08-19LIFETIME
    37STUDYXQS2324-P000137CSS0123ACSS01-First Attempt DateC-SSRS BASELINESUICIDAL BEHAVIOR2017-02-142017-02-14


    Y12022-08-19LIFETIME
    38STUDYXQS2324-P000138CSS0123BCSS01-First Attempt DamageC-SSRS BASELINESUICIDAL BEHAVIORNo physical damage or very minor physical damage00

    Y12022-08-19LIFETIME
    39STUDYXQS2324-P000139CSS0123CCSS01-First Attempt PotentialC-SSRS BASELINESUICIDAL BEHAVIORBehavior not likely to result in injury00

    Y12022-08-19LIFETIME
    40STUDYXQS2324-P00021CSS0101CSS01-Wish to be DeadC-SSRS BASELINESUICIDAL IDEATIONNoN


    Y12022-07-13LIFETIME
    41STUDYXQS2324-P00022CSS0101ACSS01-Wish to be Dead, DescribeC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    12022-07-13LIFETIME
    42STUDYXQS2324-P00023CSS0102CSS01-Non-Specific Suicidal ThoughtC-SSRS BASELINESUICIDAL IDEATIONNoN


    Y12022-07-13LIFETIME
    43STUDYXQS2324-P00024CSS0102ACSS01-Non-Specific Suicid Thought, DescrC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    12022-07-13LIFETIME
    44STUDYXQS2324-P00025CSS0103CSS01-Suicidal Ideation-No IntentC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    12022-07-13LIFETIME
    45QS...
    46STUDYXQS2324-P000217CSS0111CSS01-Most Severe Ideation, ReasonsC-SSRS BASELINEINTENSITY OF IDEATION


    NOT DONE

    12022-07-13LIFETIME
    47STUDYXQS2324-P000218CSS0112CSS01-Actual AttemptC-SSRS BASELINESUICIDAL BEHAVIORNoN


    Y12022-07-13LIFETIME
    48STUDYXQS2324-P000219CSS0113CSS01-Number of Actual AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-07-13LIFETIME
    49STUDYXQS2324-P000220CSS0113ACSS01-Actual Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-07-13LIFETIME
    50STUDYXQS2324-P000221CSS0114CSS01-Non-suicidal Self-injurious BehavC-SSRS BASELINESUICIDAL BEHAVIORNoN


    Y12022-07-13LIFETIME
    51STUDYXQS2324-P000222CSS0115CSS01-Interrupted AttemptC-SSRS BASELINESUICIDAL BEHAVIORNoN


    Y12022-07-13LIFETIME
    52STUDYXQS2324-P000223CSS0116CSS01-Number of Interrupted AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-07-13LIFETIME
    53STUDYXQS2324-P000224CSS0116ACSS01-Interrupted Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-07-13LIFETIME
    54STUDYXQS2324-P000225CSS0117CSS01-Aborted AttemptC-SSRS BASELINESUICIDAL BEHAVIORNoN


    Y12022-07-13LIFETIME
    55STUDYXQS2324-P000226CSS0118CSS01-Number of Aborted AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-07-13LIFETIME
    56STUDYXQS2324-P000227CSS0118ACSS01-Aborted Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-07-13LIFETIME
    57STUDYXQS2324-P000228CSS0119CSS01-Preparatory Acts/BehaviorC-SSRS BASELINESUICIDAL BEHAVIORYesY


    Y12022-07-13LIFETIME
    58STUDYXQS2324-P000229CSS0119ACSS01-Preparatory Acts/Behavior, DescrC-SSRS BASELINESUICIDAL BEHAVIORBought pills, Bought a gun, suicide noteBought pills, Bought a gun, suicide note


    Y12022-07-13LIFETIME
    59STUDYXQS2324-P000230CSS0120CSS01-Suicidal BehaviorC-SSRS BASELINESUICIDAL BEHAVIORYesY


    Y12022-07-13LIFETIME
    60STUDYXQS2324-P000231CSS0121ACSS01-Most Recent Attempt DateC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-07-13LIFETIME
    61STUDYXQS2324-P000232CSS0121BCSS01-Most Recent Attempt DamageC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    12022-07-13LIFETIME
    62STUDYXQS2324-P000233CSS0121CCSS01-Most Recent Attempt PotentialC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    12022-07-13LIFETIME
    63QS
    64STUDYXQS2324-P000239CSS0123CCSS01-First Attempt PotentialC-SSRS BASELINESUICIDAL BEHAVIOR


    NOT DONE

    1

    65STUDYXQS2324-P000240CSS0101CSS01-Wish to be DeadC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    2

    66STUDYXQS2324-P000241CSS0101ACSS01-Wish to be Dead, DescribeC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    2

    67STUDYXQS2324-P000242CSS0102CSS01-Non-Specific Suicidal ThoughtC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    2

    68STUDYXQS2324-P000243CSS0102ACSS01-Non-Specific Suicid Thought, DescrC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    2

    69STUDYXQS2324-P000244CSS0103CSS01-Suicidal Ideation-No IntentC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    2

    70QS

    71STUDYXQS2324-P000278CSS0103CCSS01-First Attempt PotentialC-SSRS BASELINESUICIDAL IDEATION


    NOT DONE

    2



    The SUPPQS dataset shows the items in the QS dataset which have assigned responses due to conditional branching.

    Dataset wrap
    Namesuppqs
    Dataset2
    tableidsuppqs.xpt
    STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
    STUDYXQS2324-P0001QSSEQ6QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0001QSSEQ10QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0001QSSEQ29QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0001QSSEQ33QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0001QSSEQ36QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ2QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ4QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ5QSCBRFLConditional Branching Item IndicatorYASSIGNED

    STUDYXQS2324-P0002QSSEQ17QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ19QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ20QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ23QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ24QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ26QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ27QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ31QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ32QSCBRFLConditional Branching Item IndicatorYASSIGNED
    STUDYXQS2324-P0002QSSEQ33QSCBRFLConditional Branching Item IndicatorY

    ASSIGNED

    4 SDTM Mapping Strategy

    This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

    QSSCAT alignment with QSTESTCD

    As stated in Section 3.1, Assumptions for the QS Domain Model, items on the C-SSRS BASELINE are grouped into subcategories. The following table includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

    QSSCATQSTESTCD
    SUICIDAL IDEATIONCSS0101 - CSS0105A
    INTENSITY OF IDEATIONCSS0106 - CSS0111
    SUICIDAL BEHAVIORCSS0112 - CSS0123C


    QSTESTCD = "CSS0106" QSTEST = "CSS01-Most Severe Ideation"

    QSORRES

    QSSTRESC

    QSSTRESN

    111
    222
    333
    444
    555


    QSTESTCD = "CSS0101" QSTEST = "CSS01-Wish to be Dead"

    QSTESTCD = "CSS0102" QSTEST = "CSS01-Non-Specific Suicidal Thought"

    QSTESTCD = "CSS0103" QSTEST = "CSS01-Suicidal Ideation-No Intent"

    QSTESTCD = "CSS0104" QSTEST = "CSS01-Ideation With Intent, No Plan"

    QSTESTCD = "CSS0105" QSTEST = "CSS01-Ideation With Plan/Intent"

    QSTESTCD = "CSS0112" QSTEST = "CSS01-Actual Attempt"

    QSTESTCD = "CSS0114" QSTEST = "CSS01-Non-suicidal Self-injurious Behav"

    QSTESTCD = "CSS0115" QSTEST = "CSS01-Interrupted Attempt"

    QSTESTCD = "CSS0117" QSTEST = "CSS01-Aborted Attempt"

    QSTESTCD = "CSS0119" QSTEST = "CSS01-Preparatory Acts/Behavior"

    QSTESTCD = "CSS0120" QSTEST= "CSS01-Suicidal Behavior"

    QSORRES

    QSSTRESC

    YesY
    NoN


    QSTESTCD = "CSS0107" QSTEST = "CSS01-Most Severe Ideation, Frequency"

    QSORRES

    QSSTRESC

    QSSTRESN

    Less than once a week11
    Once a week22
    2-5 times in week33
    Daily or almost daily44
    Many times each day55


    QSTESTCD = "CSS0108" QSTEST = "CSS01-Most Severe Ideation, Duration"

    QSORRES

    QSSTRESC

    QSSTRESN

    Fleeting – few seconds or minutes11
    Less than 1 hour/some of the time22
    1-4 hours/a lot of time33
    4-8 hours/most of day44
    More than 8 hours/persistent or continuous55


    QSTESTCD = "CSS0109" QSTEST = "CSS01-Most Severe Ideation, Control"

    QSORRES

    QSSTRESC

    QSSTRESN

    Easily able to control thoughts11
    Can control thoughts with little difficulty22
    Can control thoughts with some difficulty33
    Can control thoughts with a lot of difficulty44
    Unable to control thoughts55
    Does not attempt to control thoughts00


    QSTESTCD = "CSS0110" QSTEST = "CSS01-Most Severe Ideation, Deterrents"

    QSORRES

    QSSTRESC

    QSSTRESN

    Deterrents definitely stopped you from attempting suicide11
    Deterrents probably stopped you22
    Uncertain that deterrents stopped you33
    Deterrents most likely did not stop you44
    Deterrents definitely did not stop you55
    Does not apply00


    QSTESTCD = "CSS0111" QSTEST = "CSS01-Most Severe Ideation, Reasons"

    QSORRES

    QSSTRESC

    QSSTRESN

    Completely to get attention, revenge or a reaction from others11
    Mostly to get attention, revenge or a reaction from others22
    Equally to get attention, revenge or a reaction from others and to end/stop the pain33
    Mostly to end or stop the pain (you couldn’t go on living with the pain or how you were feeling)44
    Completely to end or stop the pain (you couldn’t go on living with the pain or how you were feeling)55
    Does not apply00


    QSTESTCD = "CSS0121B" QSTEST = "CSS01-Most Recent Attempt Damage"

    QSTESTCD = "CSS0122B" QSTEST = "CSS01-Most Lethal Attempt Damage"

    QSTESTCD = "CSS0123B" QSTEST = "CSS01-First Attempt Damage

    C-SSRS SINCE LAST VISIT CRF Text over 200 characters

    QSORRES Value

    QSSTRESC

    QSSTRESN


    No physical damage or very minor physical damage (e.g., surface scratches)00

    Minor physical damage (e.g., lethargic speech; first-degree burns; mild bleeding; sprains)11

    Moderate physical damage; medical attention needed (e.g., conscious but sleepy, somewhat responsive; second-degree burns; bleeding of major vessel)22
    Moderately severe physical damage; medical hospitalization and likely intensive care required (e.g., comatose with reflexes intact; third-degree burns less than 20% of body; extensive blood loss but can recover; major fracturesModerately severe physical damage; medical hospitalization and likely intensive care required33
    Severe physical damage; medical hospitalization with intensive care required (e.g., comatose without reflexes; third-degree burns over 20% of body; extensive blood loss with unstable vital signs; major damage to a vital area)Severe physical damage; medical hospitalization with intensive care required44

    Death55


    QSTESTCD = "CSS0121C" QSTEST = "CSS01-Most Recent Attempt Potential"

    QSTESTCD = "CSS0122C" QSTEST = "CSS01-Most Lethal Attempt Potential"

    QSTESTCD = "CSS0123C" QSTEST = "CSS01-First Attempt Potential"

    QSORRES

    QSSTRESC

    QSSTRESN

    Behavior not likely to result in injury00
    Behavior likely to result in injury but not likely to cause death11
    Behavior likely to result in death despite available medical care22


    5 Supplemental Qualifier Name Codes

    If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

    QSTESTCD = "test code 1" QSTEST = "test name 1"

    QSTESTCD = "test code 4" QSTEST = "test name 4"

    QSTESTCD = "test code 5" QSTEST = "test name 5"

    QSTESTCD = "test code 6" QSTEST = "test name 6"

    QSTESTCD = "test code 7" QSTEST = "test name 7"

    QSTESTCD = "test code 8" QSTEST = "test name 8"

    QSTESTCD = "test code 15" QSTEST = "test name 15"

    QSTESTCD = "test code 22" QSTEST = "test name 22"

    QSTESTCD = "test code 27" QSTEST = "test name 27"

    QSTESTCD = "test code 29" QSTEST = "test name 29"

    ...

    Omit the QSSTRESN column when it is not applicable to the dataset.

    QSTESTCD = "test code" QSTEST = "test name"

    ...

    For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

    QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

    QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

    ...

    5 Supplemental Qualifier Name Codes

    ...

    The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

    Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

    ...

    The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires  the Questionnaires (SUPPQSSUPPQS) special purpose dataset.

    Dataset wrap
    Namesuppqs
    QNAMQLABELQVAL
    Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).Label for QNAM (e.g., Contact Type)
    QSCBRFLConditional Branching Item IndicatorY
    Value of QNAM ( e.g., SUBJECT VISIT)


    End of Document