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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 VISITBASELINE 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 = "CSS0201CSS0101" - "CSS0205CSS0105") 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 7 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 BASELINE are as follows:
   1. If QSTESTCD = "CSS0101" and "CSS0102" have QSORRES = "No", then the logic branches to QSTESTCD = "CSS0112" and QSTESTCD = "CSS0103" - "CSS0111" will not be done.
   2. Items QSTESTCD = "CSS0101A" - "CSS0105A" are only completed when the response to the preceding items (QSTESTCD = "CSS0101" - "CSS0105") is "Yes"; otherwise they are not done.
   3. 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.
   4. If QSTESTCD = "CSS0115" has QSORRES = "No", then the logic branches to QSTESTCD = "CSS0117" and QSTESTCD = "CSS0116" and "CSS0116A" will not be done.
   5. If QSTESTCD = "CSS0117" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0119" and QSTESTCD = "CSS0118" and "CSS0118A" will not be done.
   6. If QSTESTCD = "CSS0119" has QSORRES =  "No", then the logic branches to QSTESTCD = "CSS0120" and QSTESTCD = "CSS0119A" will not be done.
   7. If QSTESTCD = "CSS0121B", "CSS0122B", and "CSS0123B" have QSORRES = "1", "2", "3", "4", or "5", then QSTESTCD = "CSS0121C", "CSS0122C", and "CSS0123C" will not be done.

5. A derived record is created and a QS supplemental qualifier variable is used to indicate an item was conditionally branched. When an item is not done due to conditional branching, it is represented as follows:

   1. QSDRVFL = "Y".

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

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

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

7. Some responses to the C-SSRS 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.

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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.

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