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Information 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.

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
Date2023-09-26
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

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

© 2022 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 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.

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.  

2 Copyright Status

The Research Foundation for Mental Hygiene, Inc. 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. 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. 

Information 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 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:

  • (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.) 
  • 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.

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'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. 

  1. 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.
      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 while 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 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 C-SSRS BASELINE instrument is evaluated for multiple time points. The time period of evaluation for the C-SSRS BASELINE is populated as an evaluation interval in ISO 8601 format in QSEVLINT when the interval can be precisely described as a duration, or as a text value in QSEVINTX when it cannot be precisely described as an ISO 8601 duration. The evaluation interval 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 = "CSS0106" and QSTESTCD = "CSS0103" - "CSS0105A" will not be done.
    2. If QSTESTCD = "CSS0101" has QSORRES ="Yes" and QSTESTCD = "CSS0102" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0112" and QSTESTCD = "CSS0103" - "CSS0105" 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 derived 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. 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 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.

3.2 Example for the C-SSRS BASELINE QS Domain Model

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

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLQSDRVFLVISITNUMQSDTCQSEVINTX
1STUDYXQS2324-P00011CSS0101CSS01-Wish to be DeadC-SSRS BASELINESUICIDAL IDEATIONYesY


Y
119/08/2022LIFETIME
2STUDYXQS2324-P00012CSS0101ACSS01-Wish to be Dead, DescribeC-SSRS BASELINESUICIDAL IDEATIONFall asleep and not wake upFall asleep and not wake up


Y
119/08/2022LIFETIME
3STUDYXQS2324-P00013CSS0102CSS01-Non-Specific Suicidal ThoughtC-SSRS BASELINESUICIDAL IDEATIONYesY


Y
119/08/2022LIFETIME
4STUDYXQS2324-P00014CSS0102ACSS01-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 when


Y
119/08/2022LIFETIME
5STUDYXQS2324-P00015CSS0103CSS01-Suicidal Ideation-No IntentC-SSRS BASELINESUICIDAL IDEATIONNoN


Y
119/08/2022LIFETIME
6STUDYXQS2324-P00016CSS0103ACSS01-Suicidal Ideation-No Intent, DescrC-SSRS BASELINESUICIDAL IDEATION


NOT DONE
YY119/08/2022LIFETIME
7STUDYXQS2324-P00017CSS0104CSS01-Ideation With Intent, No PlanC-SSRS BASELINESUICIDAL IDEATIONYesY


Y
119/08/2022LIFETIME
8STUDYXQS2324-P00018CSS0104ACSS01-Ideation With Intent No Plan DescrC-SSRS BASELINESUICIDAL IDEATIONI’ve thought about killing myself and howI’ve thought about killing myself and how


Y
119/08/2022LIFETIME
9STUDYXQS2324-P00019CSS0105CSS01-Ideation With Plan/IntentC-SSRS BASELINESUICIDAL IDEATIONNoN


Y
119/08/2022LIFETIME
10STUDYXQS2324-P000110CSS0105ACSS01-Ideation With Plan/Intent, DescrC-SSRS BASELINESUICIDAL IDEATION


NOT DONE
YY119/08/2022LIFETIME
11STUDYXQS2324-P000111CSS0106CSS01-Most Severe IdeationC-SSRS BASELINEINTENSITY OF IDEATION111

Y
119/08/2022LIFETIME
12STUDYXQS2324-P000112CSS0106ACSS01-Most Severe Ideation, DescriptionC-SSRS BASELINEINTENSITY OF IDEATIONWish to be DeadWish to be Dead


Y
119/08/2022LIFETIME
13STUDYXQS2324-P000113CSS0107CSS01-Most Severe Ideation, FrequencyC-SSRS BASELINEINTENSITY OF IDEATIONOnce a week22

Y
119/08/2022LIFETIME
14STUDYXQS2324-P000114CSS0108CSS01-Most Severe Ideation, DurationC-SSRS BASELINEINTENSITY OF IDEATION4-8 hours/most of day44

Y
119/08/2022LIFETIME
15STUDYXQS2324-P000115CSS0109CSS01-Most Severe Ideation, ControlC-SSRS BASELINEINTENSITY OF IDEATIONDoes not attempt to control thoughts00

Y
119/08/2022LIFETIME
16STUDYXQS2324-P000116CSS0110CSS01-Most Severe Ideation, DeterrentsC-SSRS BASELINEINTENSITY OF IDEATIONDoes not apply00

Y
119/08/2022LIFETIME
17STUDYXQS2324-P000117CSS0111CSS01-Most Severe Ideation, ReasonsC-SSRS BASELINEINTENSITY OF IDEATIONMostly to get attention, revenge or a reaction from others22

Y
119/08/2022LIFETIME
18STUDYXQS2324-P000118CSS0112CSS01-Actual AttemptC-SSRS BASELINESUICIDAL BEHAVIORYesY


Y
119/08/2022LIFETIME
19STUDYXQS2324-P000119CSS0113CSS01-Number of Actual AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR555

Y
119/08/2022LIFETIME
20STUDYXQS2324-P000120CSS0113ACSS01-Actual Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIORTo feel betterTo feel better


Y
119/08/2022LIFETIME
21STUDYXQS2324-P000121CSS0114CSS01-Non-suicidal Self-injurious BehavC-SSRS BASELINESUICIDAL BEHAVIORNoN


Y
119/08/2022LIFETIME
22STUDYXQS2324-P000122CSS0115CSS01-Interrupted AttemptC-SSRS BASELINESUICIDAL BEHAVIORYesY


Y
119/08/2022LIFETIME
23STUDYXQS2324-P000123CSS0116CSS01-Number of Interrupted AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR111

Y
119/08/2022LIFETIME
24STUDYXQS2324-P000124CSS0116ACSS01-Interrupted Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIORStopped from overdoseStopped from overdose


Y
119/08/2022LIFETIME
25STUDYXQS2324-P000125CSS0117CSS01-Aborted AttemptC-SSRS BASELINESUICIDAL BEHAVIORYesY


Y
119/08/2022LIFETIME
26STUDYXQS2324-P000126CSS0118CSS01-Number of Aborted AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR333

Y
119/08/2022LIFETIME
27STUDYXQS2324-P000127CSS0118ACSS01-Aborted Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIORParent found my lettersParent found my letters


Y
119/08/2022LIFETIME
28STUDYXQS2324-P000128CSS0119CSS01-Preparatory Acts/BehaviorC-SSRS BASELINESUICIDAL BEHAVIORNoN


Y
119/08/2022LIFETIME
29STUDYXQS2324-P000129CSS0119ACSS01-Preparatory Acts/Behavior, DescrC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY119/08/2022LIFETIME
30STUDYXQS2324-P000130CSS0120CSS01-Suicidal BehaviorC-SSRS BASELINESUICIDAL BEHAVIORYesY


Y
119/08/2022LIFETIME
31STUDYXQS2324-P000131CSS0121ACSS01-Most Recent Attempt DateC-SSRS BASELINESUICIDAL BEHAVIOR################


Y
119/08/2022LIFETIME
32STUDYXQS2324-P000132CSS0121BCSS01-Most Recent Attempt DamageC-SSRS BASELINESUICIDAL BEHAVIORModerately severe physical damage; medical hospitalization and likely intensive care required33

Y
119/08/2022LIFETIME
33STUDYXQS2324-P000133CSS0121CCSS01-Most Recent Attempt PotentialC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY119/08/2022LIFETIME
34STUDYXQS2324-P000134CSS0122ACSS01-Most Lethal Attempt DateC-SSRS BASELINESUICIDAL BEHAVIOR################


Y
119/08/2022LIFETIME
35STUDYXQS2324-P000135CSS0122BCSS01-Most Lethal Attempt DamageC-SSRS BASELINESUICIDAL BEHAVIORSevere physical damage; medical hospitalization with intensive care required44

Y
119/08/2022LIFETIME
36STUDYXQS2324-P000136CSS0122CCSS01-Most Lethal Attempt PotentialC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY119/08/2022LIFETIME
37STUDYXQS2324-P000137CSS0123ACSS01-First Attempt DateC-SSRS BASELINESUICIDAL BEHAVIOR################


Y
119/08/2022LIFETIME
38STUDYXQS2324-P000138CSS0123BCSS01-First Attempt DamageC-SSRS BASELINESUICIDAL BEHAVIORNo physical damage or very minor physical damage00

Y
119/08/2022LIFETIME
39STUDYXQS2324-P000139CSS0123CCSS01-First Attempt PotentialC-SSRS BASELINESUICIDAL BEHAVIORBehavior not likely to result in injury00

Y
119/08/2022LIFETIME
40STUDYXQS2324-P00021CSS0101CSS01-Wish to be DeadC-SSRS BASELINESUICIDAL IDEATIONNoN


Y
113/07/2022LIFETIME
41STUDYXQS2324-P00022CSS0101ACSS01-Wish to be Dead, DescribeC-SSRS BASELINESUICIDAL IDEATION


NOT DONE
YY113/07/2022LIFETIME
42STUDYXQS2324-P00023CSS0102CSS01-Non-Specific Suicidal ThoughtC-SSRS BASELINESUICIDAL IDEATIONNoN


Y
113/07/2022LIFETIME
43STUDYXQS2324-P00024CSS0102ACSS01-Non-Specific Suicid Thought, DescrC-SSRS BASELINESUICIDAL IDEATION


NOT DONE
YY113/07/2022LIFETIME
44STUDYXQS2324-P00025CSS0103CSS01-Suicidal Ideation-No IntentC-SSRS BASELINESUICIDAL IDEATION


NOT DONE
YY113/07/2022LIFETIME


...
56STUDYXQS2324-P000217CSS0111CSS01-Most Severe Ideation, ReasonsC-SSRS BASELINEINTENSITY OF IDEATION


NOT DONE
YY113/07/2022LIFETIME
57STUDYXQS2324-P000218CSS0112CSS01-Actual AttemptC-SSRS BASELINESUICIDAL BEHAVIORNoN


Y
113/07/2022LIFETIME
58STUDYXQS2324-P000219CSS0113CSS01-Number of Actual AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY113/07/2022LIFETIME
59STUDYXQS2324-P000220CSS0113ACSS01-Actual Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY113/07/2022LIFETIME
60STUDYXQS2324-P000221CSS0114CSS01-Non-suicidal Self-injurious BehavC-SSRS BASELINESUICIDAL BEHAVIORNoN


Y
113/07/2022LIFETIME
61STUDYXQS2324-P000222CSS0115CSS01-Interrupted AttemptC-SSRS BASELINESUICIDAL BEHAVIORNoN


Y
113/07/2022LIFETIME
62STUDYXQS2324-P000223CSS0116CSS01-Number of Interrupted AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY113/07/2022LIFETIME
63STUDYXQS2324-P000224CSS0116ACSS01-Interrupted Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY113/07/2022LIFETIME
64STUDYXQS2324-P000225CSS0117CSS01-Aborted AttemptC-SSRS BASELINESUICIDAL BEHAVIORNoN


Y
113/07/2022LIFETIME
65STUDYXQS2324-P000226CSS0118CSS01-Number of Aborted AttemptsC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY113/07/2022LIFETIME
66STUDYXQS2324-P000227CSS0118ACSS01-Aborted Attempt, DescribeC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY113/07/2022LIFETIME
67STUDYXQS2324-P000228CSS0119CSS01-Preparatory Acts/BehaviorC-SSRS BASELINESUICIDAL BEHAVIORYesY


Y
113/07/2022LIFETIME
68STUDYXQS2324-P000229CSS0119ACSS01-Preparatory Acts/Behavior, DescrC-SSRS BASELINESUICIDAL BEHAVIORBought pills, Bought a gun, suicide noteBought pills, Bought a gun, suicide note


Y
113/07/2022LIFETIME
69STUDYXQS2324-P000230CSS0120CSS01-Suicidal BehaviorC-SSRS BASELINESUICIDAL BEHAVIORYesY


Y
113/07/2022LIFETIME
70STUDYXQS2324-P000231CSS0121ACSS01-Most Recent Attempt DateC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY113/07/2022LIFETIME
71STUDYXQS2324-P000232CSS0121BCSS01-Most Recent Attempt DamageC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY113/07/2022LIFETIME
72STUDYXQS2324-P000233CSS0121CCSS01-Most Recent Attempt PotentialC-SSRS BASELINESUICIDAL IDEATION


NOT DONE
YY113/07/2022LIFETIME


78STUDYXQS2324-P000239CSS0123CCSS01-First Attempt PotentialC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE
YY1

79STUDYXQS2324-P000240CSS0101CSS01-Wish to be DeadC-SSRS BASELINESUICIDAL IDEATION


NOT DONE


2

80STUDYXQS2324-P000241CSS0101ACSS01-Wish to be Dead, DescribeC-SSRS BASELINESUICIDAL IDEATION


NOT DONE


2

81STUDYXQS2324-P000242CSS0102CSS01-Non-Specific Suicidal ThoughtC-SSRS BASELINESUICIDAL IDEATION


NOT DONE


2

82STUDYXQS2324-P000243CSS0102ACSS01-Non-Specific Suicid Thought, DescrC-SSRS BASELINESUICIDAL IDEATION


NOT DONE


2

83STUDYXQS2324-P000244CSS0103CSS01-Suicidal Ideation-No IntentC-SSRS BASELINESUICIDAL IDEATION


NOT DONE


2



117STUDYXQS2324-P000278CSS0123CCSS01-First Attempt PotentialC-SSRS BASELINESUICIDAL BEHAVIOR


NOT DONE


2


$warningHtml

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


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 IndicatorYASSIGNED

STUDYXQS2324-P0002QSSEQ39QSCBRFLConditional 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, items on the C-SSRS BASELINE 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.

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"

QSORRES

QSSTRESC

QSSTRESN

No physical damage or very minor physical damage00
Minor physical damage11
Moderate physical damage; medical attention needed22
Moderately severe physical damage; medical hospitalization and likely intensive care required33
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

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

QNAMQLABELQVAL
QSCBRFLConditional Branching Item IndicatorY


End of Document

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