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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 (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 Version1.3
StatusREVISION DRAFT
Date2022-08-11
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
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.
2014-09-031.2
  • 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

© 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.  

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) Since Last Visit Version 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. 

  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 (QSTESTCD = "CSS0201" - "CSS0205") 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.
    2. 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, 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, "Suicidal Behavior" contains 6 items (QSTESTCD = "CSS0112", "CSS0114", "CSS0115", "CSS0117", "CSS0119", and "CSS0120") with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". If QSORRES = "Yes", then descriptions are represented in items QSTESTCD = "CSS0113A", "CSS0116A", "CSS0118A", and "CSS0119A". QSSTRESN is null for these items. A "Total # of Attempts" (QSTESTCD = "CSS0113"), "Total # of interrupted" (QSTESTCD = "CSS0116") and "Total # of aborted" (QSTESTCD = "CSS0118) is collected in QSORRES. "Answer for Actual Attempts Only" contains "Most Recent Attempt Date" (CSS0121A), "Most Lethal Attempt Date" (QSTESTCD = "CSS0122A"), and "Initial/First Attempt Date" (CSS0123A) collected in QSORRES. "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") and descriptive text. For this section of the C-SSRS BASELINE, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
  2. The time period of evaluation for the C-SSRS BASELINE is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the C-SSRS BASELINE is "Lifetime: Time He/She Felt Most Suicidal" (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 SINCE LAST VIST are as follows:
    1. If QSTESTCD = "CSS0201" and "CSS0202" have QSORRES = "No", then the logic branches to QSTESTCD = "CSS0212" and QSTESTCD = "CSS0203" - "CSS0211" will not be done.
    2. Items QSTESTCD = "CSS0201A" - "CSS0205A" are only completed when the response to the preceding items (QSTESTCD = "CSS0201" - "CSS0205") is "Yes"; otherwise they are not done.
    3. If QSTESTCD = "CSS0212" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0214" and QSTESTCD = "CSS0213", "CSS0213A", "CSS0222A", "CSS0222B" and "CSS0222C" will not be done.
    4. If QSTESTCD = "CSS0215" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0217" and QSTESTCD = "CSS0216" and "CSS0216A" will not be done.
    5. If QSTESTCD = "CSS0217" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0219" and QSTESTCD = "CSS0218" and "CSS0218A" will not be done.
    6. If QSTESTCD = "CSS0219" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0220" and QSTESTCD = "CSS0219A" will not be done.
    7. If QSTESTCD = "CSS0222B" has QSORRES = "1", "2", "3", "4", or "5", then QSTESTCD = "CSS0222C" 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 SINCE LAST VISIT 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 the baseline visit and another subject at baseline 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.


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:

Rows 49-60:Show the subject was not evaluated on this instrument at visit 2. Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

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

Rows 49-60:Show the subject was not evaluated on this instrument at visit 2. Since the reason for not completing the visit was collected, the date is included in --DTC for when the visit was planned.



Dataset Wrapper Debug Message

Row captions have been provided, but there doesn't seem to be a dataset to which the row captions would apply.

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.

Unable to render dataset table

The table contains merged cells. Please unmerge them.

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011IDSR101IDSR1-Falling AsleepIDS-SRI never take longer than 30 minutes to fall asleep00Y12015-05-15-P7D
2STUDYXQS2324-P00012IDSR102IDSR1-Sleep During the NightIDS-SRI do not wake up at night00Y12015-05-15-P7D
3STUDYXQS2324-P00013IDSR103IDSR1-Waking Up Too EarlyIDS-SRMost of the time, I awaken no more than 30 minutes before I need to get up00Y12015-05-15-P7D
4STUDYXQS2324-P00014IDSR104IDSR1-Sleeping Too MuchIDS-SRI sleep no longer than 7-8 hours/night, without napping during the day00Y12015-05-15-P7D
5STUDYXQS2324-P00015IDSR105IDSR1-Feeling SadIDS-SRI feel sad less than half the time11Y12015-05-15-P7D
6STUDYXQS2324-P00016IDSR106IDSR1- Feeling IrritableIDS-SRI feel irritable less than half the time11Y12015-05-15-P7D
7STUDYXQS2324-P00017IDSR107IDSR1-Feeling Anxious or TenseIDS-SRI feel anxious (tense) less than half the time11Y12015-05-15-P7D
8STUDYXQS2324-P00018IDSR108IDSR1-Your Mood to Good/Desired EventsIDS-SRMy mood brightens but I do not feel like my normal self when good events occur11Y12015-05-15-P7D
9STUDYXQS2324-P00019IDSR109IDSR1-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)11Y12015-05-15-P7D
10STUDYXQS2324-P000110IDSR109AIDSR1-Mood Worse Morn/Afternoon/NightIDS-SRAfternoonAfternoon
Y12015-05-15-P7D
Rows 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-P000133IDSR131IDSR1-ScoreIDS-SR181818Y12015-05-15

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.

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.

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 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
EMOTIONAL/INFORMATIONAL SUPPORTQSSS0101 - QSSS0108
TANGIBLE SUPPORTQSSS0109 - QSSS0112
AFFECTIONATE SUPPORTQSSS0113 - QSSS0115
POSITIVE SOCIAL INTERACTIONQSSS0116 - QSSS0118
ADDITIONAL ITEMQSSS0119

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"

QSORRESQSSTRESCQSSTRESN
Original result 100
Original result 211
Original result 322

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"

QSORRESQSSTRESCQSSTRESN
I never take longer than 30 minutes to fall asleep00
I take at least 30 minutes to fall asleep, less than half the time11
I take at least 30 minutes to fall asleep, more than half the time22
I take more than 60 minutes to fall asleep, more than half the time33

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

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

QSORRESQSSTRESC
yesY
noN

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"

QSORRESQSSTRESCQSSTRESN
I have not experienced the physical sensation of feeling weighted down and without physical energy00
I have occasionally experienced periods of feeling physically weighted down and without physical energy, but without a negative effect on work, school, or activity level11
I feel physically weighted down (without physical energy) more than half the time22
I feel physically weighted down (without physical energy) most of the time, several hours per day, several days per week33


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.

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.

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)Value of QNAM ( e.g., SUBJECT VISIT)


End of Document

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