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.) 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 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

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., 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").
   3. The first section, "SUICIDAL IDEATION", contains 5 items (QSTESTCD = "CSS0101" - "CSS0105") with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". If QSORRES = "Yes", then descriptions are represented in items QSTESTCD = "CSS0101A" - "CSS0105A". QSSTRESN is null for these items.
   4. The second section "INTENSITY OF IDEATION" contains 6 items (QSTESTCD = "CSS0106" - "CSS0111") 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 = "CSS0106") is present, "Description of Ideation" (QSTESTCD = "CSS0106A") is collected as free text. For this section of the C-SSRS BASELINE,
      1. 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.
   5. The third section, "SUICIDAL BEHAVIOR" , Suicidal Behavior, contains 7 items (.
      1. QSTESTCD = "CSS0112", "CSS0114", "CSS0115", "CSS0117", and "CSS0119
      ", and "CSS0120
      1. "
      )
      1. with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". QSSTRESN is null.
         1. If QSORRES = "Yes", then descriptions
      are represented in items
      1. 1. 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.
      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.
2. The time period of evaluation for the C-SSRS BASELINE is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the C-SSRS BASELINE is "LIFETIME" (QSEVINTX = "LIFETIME").
3. Items are divided into 3 subcategories represented in QSSCAT: "SUICIDAL IDEATION", "INTENSITY OF IDEATION", and "SUICIDAL BEHAVIOR".
4. Some items on the C-SSRS BASELINE may be not done due to conditional branching. Items determined for conditional branching in the Cthe C-SSRS BASELINE are as follows:
   1. If QSTESTCD = "CSS0101" and "CSS0102" have QSORRES = "No", then the logic branches to QSTESTCD = "CSS0112" and QSTESTCD = "CSS0103" - "CSS010111" will not be done.
   2. If QSTESTCD = "CSS0101" has QSORRES ="Yes" and QSTESTCD = "CSS0102" has QSORRES = "No", then the logic branches to QSTESTCD   = "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.

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:

   QSDRVFL = "Y".

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

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

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

7. Some responses to the C-SSRS 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.BASELINE instrument.