Revision History

Revision History

© 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.

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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

.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.

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. 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 instrumentAll 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. 

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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 Cthe C-SSRS BASELINE are listed below.

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

1. The questionnaire is divided into 3 sections namely : Suicidal Ideation, Intensity of Ideation and Suicidal Behavior.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
   3. 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.
   4. 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.
   5. 1. 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 numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
   6. The third section, Suicidal Behavior, contains 7 items.The third section, "SUICIDAL BEHAVIOR" contains 7 items (
      1. QSTESTCD = "CSS0112", "CSS0114", "CSS0115", "CSS0117", and "CSS0119"
      , and "CSS0120")
      1. 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 =
      "CSS0113A", "CSS0116A", "CSS0118A", and "CSS0119A". QSSTRESN
      1. "CSS0120" QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". QSSTRESN is null for these items.
      A
      2. "Total # of Attempts" (QSTESTCD = "CSS0113"), "Total # of interrupted" (QSTESTCD = "CSS0116") and "Total # of aborted" (QSTESTCD = "CSS0118") is
      collected
      1. represented in QSORRES, QSSTRESC, and QSSTRESN.
      2. 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)
      collected
      1. 1. 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"
       
      1. 1. (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
      1. 1. ; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
   7. The time period of evaluation for the C-SSRS BASELINE is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the C-SSRS BASELINE is "LIFETIME" (QSEVINTX = "LIFETIME").
   8. Items are divided into 3 subcategories represented in QSSCAT: "SUICIDAL IDEATION", "INTENSITY OF IDEATION", and "SUICIDAL BEHAVIOR".
   9. 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:the C-SSRS BASELINE are as follows:
      1. If QSTESTCD = "CSS0101" and "CSS0102" have QSORRES = "No", then the logic branches to QSTESTCD = "CSS0112" and QSTESTCD = "CSS0103" - "CSS010111" will not be done.
      2. If QSTESTCD = "CSS0101" has QSORRES ="Yes" and QSTESTCD = "CSS0102" have has QSORRES = "No", then the logic branches to QSTESTCD   = "CSS0112CSS0106" and QSTESTCD = "CSS0103" - "CSS0111CSS0105A" 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 QSORRES QSSTRESC = "1", "2", "3", "4", or "5", then QSTESTCD = "CSS0121C", "CSS0122C", and "CSS0123C" will not be done.

   10. 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)
   11. 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.

   12. 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. 

   13. 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 instrumentBASELINE instrument.

   Rows 28-29

   Dataset wrap
   Name qs
   Dataset wrap Name qs qs.xpt Rows 5-6
   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 11-12:	Represent the QSORRES as "Wish to be Dead" when Most Severe Ideation is "1".

   : Represent the conditional branching on data entry where

   Preparatory Acts/Behavior

   Suicidal Ideation-No Intent is "No" and the associated description is missing.

   Row 33

   Rows 9-10:

   Represents items missing due to conditional branching from Most Recent Attempt Damage not being "0".

   Represent the conditional branching on data entry where Ideation With Plan/Intent is "No" and the associated description is missing. Rows 28-29

   Row 36:Represents items missing due to conditional branching from Most Lethal Attempt Damage not being "0".Rows 40-41

   : Represent the conditional branching on data entry where

   Wish to be Dead

   Preparatory Acts/Behavior is "No" and the associated description is missing. Rows

   42

   32-

   43

   33: Represent the conditional branching on data entry where

   Non-Specific Suicidal Thought is "No" and the associated description

   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

   44

   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:

   Represents items missing due to

   Represent the conditional branching

   from

   on data entry where Aborted Attempt is "No". The Number of Aborted

   Attempts

   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.

   Y

   Dataset2

   Row ROW STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSSTRESN QSSTAT QSREASND QSLOBXFL QSDRVFL VISITNUM QSDTC QSEVINTX 1 STUDYX QS 2324-P0001 1 CSS0101 CSS01-Wish to be Dead C-SSRS BASELINE SUICIDAL IDEATION Yes Y Y 1 2022-08 / -19 /2022BASELINE LIFETIME 2 STUDYX QS 2324-P0001 2 CSS0101A CSS01-Wish to be Dead, Describe C-SSRS BASELINE SUICIDAL IDEATION Fall asleep and not wake up Fall asleep and not wake up Y 1 2022-08 / -19 /2022BASELINE LIFETIME 3 STUDYX QS 2324-P0001 3 CSS0102 CSS01-Non-Specific Suicidal Thought C-SSRS BASELINE SUICIDAL IDEATION Yes Y Y 1 2022-08 / -19 /2022BASELINE LIFETIME 4 STUDYX QS 2324-P0001 4 CSS0102A CSS01-Non-Specific Suicid Thought, Descr C-SSRS BASELINE SUICIDAL IDEATION I thought about taking an overdose but I never made a specific plan as to when I thought about taking an overdose but I never made a specific plan as to when Y 1 2022-08 / -19 /2022BASELINE LIFETIME 5 STUDYX QS 2324-P0001 5 CSS0103 CSS01-Suicidal Ideation-No Intent C-SSRS BASELINE SUICIDAL IDEATION No N Y 1 2022-08 / -19 /2022BASELINE LIFETIME 6 STUDYX QS 2324-P0001 6 CSS0103A CSS01-Suicidal Ideation-No Intent, Descr C-SSRS BASELINE SUICIDAL IDEATION NOT DONE

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   7

   STUDYX

   QS

   2324-P0001

   7

   CSS0104

   CSS01-Ideation With Intent, No Plan

   C-SSRS BASELINE

   SUICIDAL IDEATION

   Yes

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   8

   STUDYX

   QS

   2324-P0001

   8

   CSS0104A

   CSS01-Ideation With Intent No Plan Descr

   C-SSRS BASELINE

   SUICIDAL IDEATION

   I’ve thought about killing myself and how

   I’ve thought about killing myself and how

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   9

   STUDYX

   QS

   2324-P0001

   9

   CSS0105

   CSS01-Ideation With Plan/Intent

   C-SSRS BASELINE

   SUICIDAL IDEATION

   No

   N

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   10

   STUDYX

   QS

   2324-P0001

   10

   CSS0105A

   CSS01-Ideation With Plan/Intent, Descr

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   YY

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME
   11	STUDYX	QS	2324-P0001	11	CSS0106	CSS01-Most Severe Ideation	C-SSRS BASELINE	INTENSITY OF IDEATION	1	1	1			Y	1	2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   12

   STUDYX

   QS

   2324-P0001

   12

   CSS0106A

   CSS01-Most Severe Ideation, Description

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   Wish to be Dead

   Wish to be Dead

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   13

   STUDYX

   QS

   2324-P0001

   13

   CSS0107

   CSS01-Most Severe Ideation, Frequency

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   Once a week

   2

   2

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   14

   STUDYX

   QS

   2324-P0001

   14

   CSS0108

   CSS01-Most Severe Ideation, Duration

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   4-8 hours/most of day

   4

   4

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   15

   STUDYX

   QS

   2324-P0001

   15

   CSS0109

   CSS01-Most Severe Ideation, Control

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   Does not attempt to control thoughts

   0

   0

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   16

   STUDYX

   QS

   2324-P0001

   16

   CSS0110

   CSS01-Most Severe Ideation, Deterrents

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   Does not apply

   0

   0

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   17

   STUDYX

   QS

   2324-P0001

   17

   CSS0111

   CSS01-Most Severe Ideation, Reasons

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   Mostly to get attention, revenge or a reaction from others

   2

   2

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   18

   STUDYX

   QS

   2324-P0001

   18

   CSS0112

   CSS01-Actual Attempt

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME
   19	STUDYX	QS	2324-P0001	19	CSS0113	CSS01-Number of Actual Attempts	C-SSRS BASELINE	SUICIDAL BEHAVIOR	5	5	5			Y	1	2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   20

   STUDYX

   QS

   2324-P0001

   20

   CSS0113A

   CSS01-Actual Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   To feel better

   To feel better

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   21

   STUDYX

   QS

   2324-P0001

   21

   CSS0114

   CSS01-Non-suicidal Self-injurious Behav

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   22

   STUDYX

   QS

   2324-P0001

   22

   CSS0115

   CSS01-Interrupted Attempt

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME
   23	STUDYX	QS	2324-P0001	23	CSS0116	CSS01-Number of Interrupted Attempts	C-SSRS BASELINE	SUICIDAL BEHAVIOR	1	1	1			Y	1	2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   24

   STUDYX

   QS

   2324-P0001

   24

   CSS0116A

   CSS01-Interrupted Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Stopped from overdose

   Stopped from overdose

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   25

   STUDYX

   QS

   2324-P0001

   25

   CSS0117

   CSS01-Aborted Attempt

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME
   26	STUDYX	QS	2324-P0001	26	CSS0118	CSS01-Number of Aborted Attempts	C-SSRS BASELINE	SUICIDAL BEHAVIOR	3	3	3			Y	1	2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   27

   STUDYX

   QS

   2324-P0001

   27

   CSS0118A

   CSS01-Aborted Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Parent found my letters

   Parent found my letters

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   28

   STUDYX

   QS

   2324-P0001

   28

   CSS0119

   CSS01-Preparatory Acts/Behavior

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   29

   STUDYX

   QS

   2324-P0001

   29

   CSS0119A

   CSS01-Preparatory Acts/Behavior, Descr

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   30

   STUDYX

   QS

   2324-P0001

   30

   CSS0120

   CSS01-Suicidal Behavior

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   Y

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME
   31	STUDYX	QS	2324-P0001	31	CSS0121A	CSS01-Most Recent Attempt Date	C-SSRS BASELINE	SUICIDAL BEHAVIOR

   2/14/2016

   2022-07-17

   2022-07-17

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   32

   STUDYX

   QS

   2324-P0001

   32

   CSS0121B

   CSS01-Most Recent Attempt Damage

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Moderately severe physical damage; medical hospitalization and likely intensive care required

   3

   3

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   33

   STUDYX

   QS

   2324-P0001

   33

   CSS0121C

   CSS01-Most Recent Attempt Potential

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME
   34	STUDYX	QS	2324-P0001	34	CSS0122A	CSS01-Most Lethal Attempt Date	C-SSRS BASELINE	SUICIDAL BEHAVIOR	2021-12-24

   12/31/2013

   2021-12-24

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   35

   STUDYX

   QS

   2324-P0001

   35

   CSS0122B

   CSS01-Most Lethal Attempt Damage

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Severe physical damage; medical hospitalization with intensive care required

   4

   4

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   36

   STUDYX

   QS

   2324-P0001

   36

   CSS0122C

   CSS01-Most Lethal Attempt Potential

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME
   37	STUDYX	QS	2324-P0001	37	CSS0123A	CSS01-First Attempt Date	C-SSRS BASELINE	SUICIDAL BEHAVIOR

   3/27/2009

   2017-02-14

   2017-02-14

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   38

   STUDYX

   QS

   2324-P0001

   38

   CSS0123B

   CSS01-First Attempt Damage

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No physical damage or very minor physical damage

   0

   0

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   39

   STUDYX

   QS

   2324-P0001

   39

   CSS0123C

   CSS01-First Attempt Potential

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Behavior not likely to result in injury

   0

   0

   Y

   1

   2022-08

   /

   -19

   /2022BASELINE

   LIFETIME

   40

   STUDYX

   QS

   2324-P0002

   1

   CSS0101

   CSS01-Wish to be Dead

   C-SSRS BASELINE

   SUICIDAL IDEATION

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   41

   STUDYX

   QS

   2324-P0002

   2

   CSS0101A

   CSS01-Wish to be Dead, Describe

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   42

   STUDYX

   QS

   2324-P0002

   3

   CSS0102

   CSS01-Non-Specific Suicidal Thought

   C-SSRS BASELINE

   SUICIDAL IDEATION

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   43

   STUDYX

   QS

   2324-P0002

   4

   CSS0102A

   CSS01-Non-Specific Suicid Thought, Descr

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   44

   STUDYX

   QS

   2324-P0002

   5

   CSS0103

   CSS01-Suicidal Ideation-No Intent

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022

   LIFETIME

   BASELINE

   45

   …

   …

   QS

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   ...

   56

   46

   STUDYX

   QS

   2324-P0002

   17

   CSS0111

   CSS01-Most Severe Ideation, Reasons

   C-SSRS BASELINE

   INTENSITY OF IDEATION

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   57

   47

   STUDYX

   QS

   2324-P0002

   18

   CSS0112

   CSS01-Actual Attempt

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   58

   48

   STUDYX

   QS

   2324-P0002

   19

   CSS0113

   CSS01-Number of Actual Attempts

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   59

   49

   STUDYX

   QS

   2324-P0002

   20

   CSS0113A

   CSS01-Actual Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   60

   50

   STUDYX

   QS

   2324-P0002

   21

   CSS0114

   CSS01-Non-suicidal Self-injurious Behav

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   61

   51

   STUDYX

   QS

   2324-P0002

   22

   CSS0115

   CSS01-Interrupted Attempt

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   62

   52

   STUDYX

   QS

   2324-P0002

   23

   CSS0116

   CSS01-Number of Interrupted Attempts

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   63

   53

   STUDYX

   QS

   2324-P0002

   24

   CSS0116A

   CSS01-Interrupted Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   64

   54

   STUDYX

   QS

   2324-P0002

   25

   CSS0117

   CSS01-Aborted Attempt

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   No

   N

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   65

   55

   STUDYX

   QS

   2324-P0002

   26

   CSS0118

   CSS01-Number of Aborted Attempts

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   66

   56

   STUDYX

   QS

   2324-P0002

   27

   CSS0118A

   CSS01-Aborted Attempt, Describe

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   67

   57

   STUDYX

   QS

   2324-P0002

   28

   CSS0119

   CSS01-Preparatory Acts/Behavior

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   Y

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   68

   58

   STUDYX

   QS

   2324-P0002

   29

   CSS0119A

   CSS01-Preparatory Acts/Behavior, Descr

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Bought pills, Bought a gun, suicide note

   Bought pills, Bought a gun, suicide note

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   69

   59

   STUDYX

   QS

   2324-P0002

   30

   CSS0120

   CSS01-Suicidal Behavior

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   Yes

   Y

   Y

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   70

   60

   STUDYX

   QS

   2324-P0002

   31

   CSS0121A

   CSS01-Most Recent Attempt Date

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   71

   61

   STUDYX

   QS

   2324-P0002

   32

   CSS0121B

   CSS01-Most Recent Attempt Damage

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022BASELINE

   LIFETIME

   72

   62

   STUDYX

   QS

   2324-P0002

   33

   CSS0121C

   CSS01-Most Recent Attempt Potential

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   YY

   1

   2022-07

   /

   -13

   /2022

   LIFETIME

   BASELINE

   63

   …

   …

   QS

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   78

   64

   STUDYX

   QS

   2324-P0002

   39

   CSS0123C

   CSS01-First Attempt Potential

   C-SSRS BASELINE

   SUICIDAL BEHAVIOR

   NOT DONE

   YY

   1

   07/13/2022BASELINE79

   65

   STUDYX

   QS

   2324-P0002

   40

   CSS0101

   CSS01-Wish to be Dead

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   80

   66

   STUDYX

   QS

   2324-P0002

   41

   CSS0101A

   CSS01-Wish to be Dead, Describe

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   81

   67

   STUDYX

   QS

   2324-P0002

   42

   CSS0102

   CSS01-Non-Specific Suicidal Thought

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   82

   68

   STUDYX

   QS

   2324-P0002

   43

   CSS0102A

   CSS01-Non-Specific Suicid Thought, Descr

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   83

   69

   STUDYX

   QS

   2324-P0002

   44

   CSS0103

   CSS01-Suicidal Ideation-No Intent

   C-SSRS BASELINE

   SUICIDAL IDEATION

   NOT DONE

   2

   …

   70	…

   …

   QS

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   …

   117

   71	STUDYX	QS	2324-P0002	78

   CSS0123C

   CSS0103C

   CSS01-First Attempt Potential

   C-SSRS BASELINE

   SUICIDAL

   BEHAVIOR

   IDEATION

   NOT DONE

   2