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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 = "CSS0201A" - "CSS0205A". QSSTRESN is null for these items.
   2. The second section "Intensity of Ideation" contains 6 items (QSTESTCD = "CSS0206" - "CSS0211") 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 = "CSS0206") is present, "Description of Ideation" (QSTESTCD = "CSS0206A") is collected as free text. For this section of the C-SSRS SINCE LAST VISIT, 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 = "CSS0212", "CSS0214", "CSS0215", "CSS0217", "CSS0219" - "CSS0221") with QSORRES = "Yes" or "No" and QSSTRESC = "Y" or "N". If QSORRES = "Yes", then descriptions are represented in items QSTESTCD = "CSS0213A", "CSS0216A", "CSS0218A" and "CSS0219A". QSSTRESN is null for these items. A "Total # of Attempts" (QSTESTCD = "CSS0213"), "Total # of interrupted" (QSTESTCD = "CSS0216") and "Total # of aborted" (QSTESTCD = "CSS0218) is collected in QSORRES. "Answer for Actual Attempts Only" contains "most lethal attempt date" (QSTESTCD = "CSS0222A") collected in QSORRES. "Actual Lethality/Medical Damage" (QSTESTCD = "CSS0222B") and "Potential Lethality" (QSTESTCD = "CSS0222C") are represented with a numeric score (either "0-5" or "0-2") and descriptive text. For this section of the C-SSRS SINCE LAST VISIT, 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 SINCE LAST VISIT 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 SINCE LAST VISIT is "SINCE LAST VISIT" (QSEVINTX = "SINCE LAST VISIT").
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 SINCE LAST VISIT 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

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C-SSRS BASELINE QS Domain Model

The

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 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

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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

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in QSORRES.

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This result is then

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represented as a standard numeric score in QSSTRESN and as a standard character representation

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in QSSTRESC.

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 When

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a result is character only,

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the result is

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transformed into the standard character representation in QSSTRESC and QSSTRESN is null.

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The table represents the items from the C-SSRS BASELINE instrument.

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1. Include a description of scale score or other possible responses (You may need multiple numbered points for this, tho the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleep"). For the QRS Short_Name, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. (replace this sentence for instruments with text only responses with “QSORRES and QSSTRESC are populated with the text description and QSSTRESN is not represented with a numeric value”.

2. Include a description of the evaluation interval if one exists. This may be numeric (QSEVLINT) or text (QSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use QSEVINTX instead of "QSEVLINT field in ISO 8601 format" and replace "the past 7 days" with the text (e.g., "DAYTIME'". Refer to SDTMIG Section 2.2.5 Timing Variables for All Classes. The evaluation interval needs to be clearly defined on the CRF. Remove this point if it does not apply.: The time period of evaluation for theQRS Short_Name is populated in the QSEVLINTfield in ISO 8601 format (or QSEVINTX, as appropriate) when the evaluation interval can be precisely described as duration. The evaluation interval for the QRS Short_Name is the past 7 days (QSEVLINT = "-P7D"). Alternatively, if it cannot be described as an ISO 8601 duration:  The time period of evaluation for the QRS Short_Name is populated in the QSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration.

3. If there are subcategories, include a note that subcategories will be represented in QSSCAT. Also provide a list of the subcategories unless one is already provided in the description preceding the assumptions. Remove this point if it does not apply.  For example:  Items are divided into 5 subcategories represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".

4. Records are created in qs.xpt for every item on the instrument: 

   1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE".  If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "LOGICALLY SKIPPED ITEM" or QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

5. If the instrument standards currently being developed includes logically skipped items, insert:  Some items on the QRS Short_Name may be logically skipped per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a logically skipped item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min). A record is created in rs.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:

   1. RSSTAT = "NOT DONE".       

   2. RSREASND = "LOGICALLY SKIPPED ITEM".
      

   3. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).

6. Include this point if score(s) are submitted to SDTM. Update blue text: The QRS Short_Name instrument includes a total score (and other scores as needed.  If so, change "that is" to "that are") that is considered as captured data on the CRF and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].

   1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

   2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.

7. This language is currently under review. Evaluator information is only to be included when the information is collected directly on the CRF. instruments will no longer be using QSEVAL/QSEVALID; however RSEVAL/RSEVALID and FTEVAL/FTEVALID will continue to be used on Clinical Classifications and Functional Tests. Language for Clinical Classifications and Functional tests follows; language for instruments is currently under review. Remove this point if it does not apply.

   For Clinical Classifications and Functional Tests (only when collected on the CRF):  *** This section to be updated.  QSEVAL/ID, FTEVAL/ID, and RSEVAL/ID will no longer be used.  Supplemental qualifiers will represent this information. *** For QRS Short_Name, the evaluator is defined as the (the appropriate term from controlled terminology). Alternatively, if only evaluator name or initials could be collected: For QRS Short_Name, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. CDISC Controlled Terminology is available for Evaluator (e.g., --EVAL = "HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., --EVALID = "RATER 1"). To reiterate, only include this point if the evaluator/administrator is collected directly on the CRF.

8. Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the QRS Short_Name will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

9. Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the QRS Short_Name 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.
   

10. Terminology

    1. QSCAT, QSTESTCD, and QSTEST (and other variables such as QSORRESU as needed) values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, result, and unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

3.2 Example for the QRS Short_Name QS Domain Model

The QRS Short_Name 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 for the QRS Short_Name instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. When there are numeric results, then use this sentence next, "This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC." When the results are character only, then use these sentences next, "This result is then transformed into the standard character representation in QSSTRESC. QSSTRESN is null as there are no standardized numeric results for this instrument."

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