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Title | Columbia-Suicide Severity Rating Scale Baseline Version 1/14/2009 (C-SSRS BASELINE) |
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CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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QRS Short Name | |
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QRS Permission Status | Approved |
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Team | CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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Supplement Version | 2.0 |
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Status | FINAL |
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Date | 2023-02-27 |
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Notes | |
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Known IssuesIssue | - The concept of “conditional branching” in QRS instruments is when the instrument directs the subject to another item of the instrument based on the result of a response compare for a given condition. This concept was reviewed with the CDISC standards teams and it was agreed to use this term instead of “logically skipped item” moving forward for this QRS instrument use case. A new QRS variable named “QSCBRFL” with the description of “Conditional Branched Item Indicator” has been requested for release in SDTMIG v4.0. This new variable will streamline the data representation of conditional branched items.
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© 2023 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.
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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.
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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.
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- (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.)
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.
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- The questionnaire is divided into 3 sections: Suicidal Ideation, Intensity of Ideation, and Suicidal Behavior.
- 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 provided for QSTESTCD = "CSS0101A" - "CSS0105A" are represented in QSORRES and QSSTRESC. QSSTRESN is null for these items.
- The second section, Intensity of Ideation, contains 6 items.
- QSTESTCD = "CSS0106" is rating the most severe ideation with responses represented with a numeric score (1-5) in QSORRES, QSSTRESC, and QSSTRESN.
- "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.
- 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.
- 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.
- The third section, Suicidal Behavior, contains 7 items.
- QSTESTCD = "CSS0112", "CSS0114", "CSS0115", "CSS0117", and "CSS0119" with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". QSSTRESN is null.
- 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.
- For QSTESTCD = "CSS0120" QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". QSSTRESN is null for these items.
- "Total # of Attempts" (QSTESTCD = "CSS0113"), "Total # of interrupted" (QSTESTCD = "CSS0116") and "Total # of aborted" (QSTESTCD = "CSS0118") is represented in QSORRES, QSSTRESC, and QSSTRESN.
- The section "Answer for Actual Attempts Only" contains the following:
- "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.
- "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; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
- 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").
- Items are divided into 3 subcategories represented in QSSCAT: "SUICIDAL IDEATION", "INTENSITY OF IDEATION", and "SUICIDAL BEHAVIOR".
- 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:
- If QSTESTCD = "CSS0101" and "CSS0102" have QSORRES = "No", then the logic branches to QSTESTCD = "CSS0112" and QSTESTCD = "CSS0103" - "CSS010111" will not be done.
- If QSTESTCD = "CSS0101" has QSORRES ="Yes" and QSTESTCD = "CSS0102" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0106" and QSTESTCD = "CSS0103" - "CSS0105A" will not be done.
- Items QSTESTCD = "CSS0101A" - "CSS0105A" are only completed when the response to the preceding items (QSTESTCD = "CSS0101" - "CSS0105") is "Yes"; otherwise they are not done.
- 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.
- If QSTESTCD = "CSS0115" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0117" and QSTESTCD = "CSS0116", and "CSS0116A" will not be done.
- If QSTESTCD = "CSS0117" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0119" and QSTESTCD = "CSS0118", and "CSS0118A" will not be done.
- If QSTESTCD = "CSS0119" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0120", and QSTESTCD = "CSS0119A" will not be done.
- If QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B" have QSSTRESC = "1", "2", "3", "4", or "5", then QSTESTCD = "CSS0121C", "CSS0122C", and "CSS0123C" will not be done.
A 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:
QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y” (This is a QS supplemental qualifier variable.)
QSSTAT = "NOT DONE", and QSREASND is missing
- QSORRES, QSSTRESC, and QSSTRESN are set to null (missing)
- Records are created in qs.xpt for every item on the sponsor's version of the instrument.
- For items not done due to conditional branching, refer to assumptions 4 and 5.
- In the unexpected situation where the reason is unknown, then QSORRES, QSSTRESC and QSSTRESN are all missing, QSSTAT = "NOT DONE", and QSREASND is missing.
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.
Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
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.
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| qs.xpt Rows 5-6: | Represent the conditional branching on data entry where Suicidal Ideation-No Intent is "No" and the associated description is missing. | Rows 9-10: | Represent the conditional branching on data entry where Ideation With Plan/Intent is "No" and the associated description is missing. | Rows 28-29: | Represent the conditional branching on data entry where Preparatory Acts/Behavior is "No" and the associated description is missing. | Rows 32-33: | Represent the conditional branching on data entry where Most Recent Attempt Damage is "3" and Most Recent Attempt Potential is missing. | Rows 35-36: | Represent the conditional branching on data entry where Most Lethal Attempt Damage is "4" and Most Lethal Attempt Potential is missing. | Rows 40-56: | Represents items missing due to conditional branching from the items Wish to be Dead and Non-Specific Suicidal Thought being "No". | Rows 57-59: | Represent the conditional branching on data entry where Actual Attempt is "No". The Number of Actual Attempts and the associated description are missing. | Rows 61-63: | Represent the conditional branching on data entry where Interrupted Attempt is "No". The Number of Interrupted Attempts and the associated description are missing. | Rows 64-66: | Represent the conditional branching on data entry where Aborted Attempt is "No". The Number of Aborted Attempt and the associated description are missing. | Rows 70-78: | Represents items missing due to conditional branching from Actual Attempt being "No". | Rows 79-117: | Show the subject was not evaluated on this instrument at visit 2. A record for each item on the instrument is created with a status of '"NOT DONE'". Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. |
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ROW | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVINTX | 1 | STUDYX | QS | 2324-P0001 | 1 | CSS0101 | CSS01-Wish to be Dead | C-SSRS BASELINE | SUICIDAL IDEATION | Yes | Y |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 3 | STUDYX | QS | 2324-P0001 | 3 | CSS0102 | CSS01-Non-Specific Suicidal Thought | C-SSRS BASELINE | SUICIDAL IDEATION | Yes | Y |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 5 | STUDYX | QS | 2324-P0001 | 5 | CSS0103 | CSS01-Suicidal Ideation-No Intent | C-SSRS BASELINE | SUICIDAL IDEATION | No | N |
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| Y | 1 | 2022-08-19 | LIFETIME | 6 | STUDYX | QS | 2324-P0001 | 6 | CSS0103A | CSS01-Suicidal Ideation-No Intent, Descr | C-SSRS BASELINE | SUICIDAL IDEATION |
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| NOT DONE |
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| 1 | 2022-08-19 | LIFETIME | 7 | STUDYX | QS | 2324-P0001 | 7 | CSS0104 | CSS01-Ideation With Intent, No Plan | C-SSRS BASELINE | SUICIDAL IDEATION | Yes | Y |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 9 | STUDYX | QS | 2324-P0001 | 9 | CSS0105 | CSS01-Ideation With Plan/Intent | C-SSRS BASELINE | SUICIDAL IDEATION | No | N |
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| Y | 1 | 2022-08-19 | LIFETIME | 10 | STUDYX | QS | 2324-P0001 | 10 | CSS0105A | CSS01-Ideation With Plan/Intent, Descr | C-SSRS BASELINE | SUICIDAL IDEATION |
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| NOT DONE |
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| 1 | 2022-08-19 | LIFETIME | 11 | STUDYX | QS | 2324-P0001 | 11 | CSS0106 | CSS01-Most Severe Ideation | C-SSRS BASELINE | INTENSITY OF IDEATION | 1 | 1 | 1 |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 13 | STUDYX | QS | 2324-P0001 | 13 | CSS0107 | CSS01-Most Severe Ideation, Frequency | C-SSRS BASELINE | INTENSITY OF IDEATION | Once a week | 2 | 2 |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 16 | STUDYX | QS | 2324-P0001 | 16 | CSS0110 | CSS01-Most Severe Ideation, Deterrents | C-SSRS BASELINE | INTENSITY OF IDEATION | Does not apply | 0 | 0 |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 18 | STUDYX | QS | 2324-P0001 | 18 | CSS0112 | CSS01-Actual Attempt | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
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| Y | 1 | 2022-08-19 | LIFETIME | 19 | STUDYX | QS | 2324-P0001 | 19 | CSS0113 | CSS01-Number of Actual Attempts | C-SSRS BASELINE | SUICIDAL BEHAVIOR | 5 | 5 | 5 |
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| Y | 1 | 2022-08-19 | LIFETIME | 20 | STUDYX | QS | 2324-P0001 | 20 | CSS0113A | CSS01-Actual Attempt, Describe | C-SSRS BASELINE | SUICIDAL BEHAVIOR | To feel better | To feel better |
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| Y | 1 | 2022-08-19 | LIFETIME | 21 | STUDYX | QS | 2324-P0001 | 21 | CSS0114 | CSS01-Non-suicidal Self-injurious Behav | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
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| Y | 1 | 2022-08-19 | LIFETIME | 22 | STUDYX | QS | 2324-P0001 | 22 | CSS0115 | CSS01-Interrupted Attempt | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
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| Y | 1 | 2022-08-19 | LIFETIME | 23 | STUDYX | QS | 2324-P0001 | 23 | CSS0116 | CSS01-Number of Interrupted Attempts | C-SSRS BASELINE | SUICIDAL BEHAVIOR | 1 | 1 | 1 |
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| Y | 1 | 2022-08-19 | LIFETIME | 24 | STUDYX | QS | 2324-P0001 | 24 | CSS0116A | CSS01-Interrupted Attempt, Describe | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Stopped from overdose | Stopped from overdose |
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| Y | 1 | 2022-08-19 | LIFETIME | 25 | STUDYX | QS | 2324-P0001 | 25 | CSS0117 | CSS01-Aborted Attempt | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
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| Y | 1 | 2022-08-19 | LIFETIME | 26 | STUDYX | QS | 2324-P0001 | 26 | CSS0118 | CSS01-Number of Aborted Attempts | C-SSRS BASELINE | SUICIDAL BEHAVIOR | 3 | 3 | 3 |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 28 | STUDYX | QS | 2324-P0001 | 28 | CSS0119 | CSS01-Preparatory Acts/Behavior | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
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| Y | 1 | 2022-08-19 | LIFETIME | 29 | STUDYX | QS | 2324-P0001 | 29 | CSS0119A | CSS01-Preparatory Acts/Behavior, Descr | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
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| NOT DONE |
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| 1 | 2022-08-19 | LIFETIME | 30 | STUDYX | QS | 2324-P0001 | 30 | CSS0120 | CSS01-Suicidal Behavior | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
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| Y | 1 | 2022-08-19 | LIFETIME | 31 | STUDYX | QS | 2324-P0001 | 31 | CSS0121A | CSS01-Most Recent Attempt Date | C-SSRS BASELINE | SUICIDAL BEHAVIOR | 2022-07-17 | 2022-07-17 |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 33 | STUDYX | QS | 2324-P0001 | 33 | CSS0121C | CSS01-Most Recent Attempt Potential | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
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| NOT DONE |
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| 1 | 2022-08-19 | LIFETIME | 34 | STUDYX | QS | 2324-P0001 | 34 | CSS0122A | CSS01-Most Lethal Attempt Date | C-SSRS BASELINE | SUICIDAL BEHAVIOR | 2021-12-24 | 2021-12-24 |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 36 | STUDYX | QS | 2324-P0001 | 36 | CSS0122C | CSS01-Most Lethal Attempt Potential | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
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| NOT DONE |
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| 1 | 2022-08-19 | LIFETIME | 37 | STUDYX | QS | 2324-P0001 | 37 | CSS0123A | CSS01-First Attempt Date | C-SSRS BASELINE | SUICIDAL BEHAVIOR | 2017-02-14 | 2017-02-14 |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | 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 |
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| Y | 1 | 2022-08-19 | LIFETIME | 40 | STUDYX | QS | 2324-P0002 | 1 | CSS0101 | CSS01-Wish to be Dead | C-SSRS BASELINE | SUICIDAL IDEATION | No | N |
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| Y | 1 | 2022-07-13 | LIFETIME | 41 | STUDYX | QS | 2324-P0002 | 2 | CSS0101A | CSS01-Wish to be Dead, Describe | C-SSRS BASELINE | SUICIDAL IDEATION |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 42 | STUDYX | QS | 2324-P0002 | 3 | CSS0102 | CSS01-Non-Specific Suicidal Thought | C-SSRS BASELINE | SUICIDAL IDEATION | No | N |
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| Y | 1 | 2022-07-13 | LIFETIME | 43 | STUDYX | QS | 2324-P0002 | 4 | CSS0102A | CSS01-Non-Specific Suicid Thought, Descr | C-SSRS BASELINE | SUICIDAL IDEATION |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 44 | STUDYX | QS | 2324-P0002 | 5 | CSS0103 | CSS01-Suicidal Ideation-No Intent | C-SSRS BASELINE | SUICIDAL IDEATION |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 45 | … | QS | … | … | … | … | … | … | … | … | … | … | … | … | … | … | ... | 46 | STUDYX | QS | 2324-P0002 | 17 | CSS0111 | CSS01-Most Severe Ideation, Reasons | C-SSRS BASELINE | INTENSITY OF IDEATION |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 47 | STUDYX | QS | 2324-P0002 | 18 | CSS0112 | CSS01-Actual Attempt | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
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| Y | 1 | 2022-07-13 | LIFETIME | 48 | STUDYX | QS | 2324-P0002 | 19 | CSS0113 | CSS01-Number of Actual Attempts | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 49 | STUDYX | QS | 2324-P0002 | 20 | CSS0113A | CSS01-Actual Attempt, Describe | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 50 | STUDYX | QS | 2324-P0002 | 21 | CSS0114 | CSS01-Non-suicidal Self-injurious Behav | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
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| Y | 1 | 2022-07-13 | LIFETIME | 51 | STUDYX | QS | 2324-P0002 | 22 | CSS0115 | CSS01-Interrupted Attempt | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
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| Y | 1 | 2022-07-13 | LIFETIME | 52 | STUDYX | QS | 2324-P0002 | 23 | CSS0116 | CSS01-Number of Interrupted Attempts | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 53 | STUDYX | QS | 2324-P0002 | 24 | CSS0116A | CSS01-Interrupted Attempt, Describe | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 54 | STUDYX | QS | 2324-P0002 | 25 | CSS0117 | CSS01-Aborted Attempt | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
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| Y | 1 | 2022-07-13 | LIFETIME | 55 | STUDYX | QS | 2324-P0002 | 26 | CSS0118 | CSS01-Number of Aborted Attempts | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 56 | STUDYX | QS | 2324-P0002 | 27 | CSS0118A | CSS01-Aborted Attempt, Describe | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
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| NOT DONE |
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| 1 | 2022-07-13 | LIFETIME | 57 | STUDYX | QS | 2324-P0002 | 28 | CSS0119 | CSS01-Preparatory Acts/Behavior | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
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| Y | 1 | 2022-07-13 | LIFETIME | 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 | LIFETIME | 59 | STUDYX | QS | 2324-P0002 | 30 | CSS0120 | CSS01-Suicidal Behavior | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
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|
| Y | 1 | 2022-07-13 | LIFETIME | 60 | STUDYX | QS | 2324-P0002 | 31 | CSS0121A | CSS01-Most Recent Attempt Date | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | 61 | STUDYX | QS | 2324-P0002 | 32 | CSS0121B | CSS01-Most Recent Attempt Damage | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | 62 | STUDYX | QS | 2324-P0002 | 33 | CSS0121C | CSS01-Most Recent Attempt Potential | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | 63 | … | QS | … | … | … | … | … | … | … | … | … | … | … | … | … | … | … | 64 | STUDYX | QS | 2324-P0002 | 39 | CSS0123C | CSS01-First Attempt Potential | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 |
|
| 65 | STUDYX | QS | 2324-P0002 | 40 | CSS0101 | CSS01-Wish to be Dead | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 2 |
|
| 66 | STUDYX | QS | 2324-P0002 | 41 | CSS0101A | CSS01-Wish to be Dead, Describe | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 2 |
|
| 67 | STUDYX | QS | 2324-P0002 | 42 | CSS0102 | CSS01-Non-Specific Suicidal Thought | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 2 |
|
| 68 | STUDYX | QS | 2324-P0002 | 43 | CSS0102A | CSS01-Non-Specific Suicid Thought, Descr | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 2 |
|
| 69 | STUDYX | QS | 2324-P0002 | 44 | CSS0103 | CSS01-Suicidal Ideation-No Intent | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 2 |
|
| 70 | … | QS | … | … | … | … | … | … | … | … | … | … | … | … | … |
|
| 71 | STUDYX | QS | 2324-P0002 | 78 | CSS0103C | CSS01-First Attempt Potential | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 2 |
|
|
|
|
...
Dataset wrap |
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|
Dataset2 |
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| STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | STUDYX | QS | 2324-P0001 | QSSEQ | 6 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0001 | QSSEQ | 10 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0001 | QSSEQ | 29 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0001 | QSSEQ | 33 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0001 | QSSEQ | 36 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 2 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 4 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 5 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | … | … | … | … |
| … | … | … | … | STUDYX | QS | 2324-P0002 | QSSEQ | 17 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 19 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 20 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 23 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 24 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 26 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 27 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 31 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 32 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | STUDYX | QS | 2324-P0002 | QSSEQ | 33 | QSCBRFL | Conditional Branching Item Indicator | Y | |
|
|
4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.
QSSCAT alignment with QSTESTCD.
As stated in Section 3.1, Assumptions for the QS Domain Model, items on the C-SSRS BASELINE are grouped into subcategories. The following table includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.
...
The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires the Questionnaires (SUPPQS) special purpose dataset.
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