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1. The scale points include a 0 to 10 rating with 0 = "None", 10 = "As bad as you can imagine", and all points in between only having a numeric value. For the ADSD V1.0, QSORRES is populated with the text description for "None" and "As bad as you can imagine" and the numeric value for all other answers, 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 ADSD V1.0 is populated in the QSEVINTX when the evaluation interval can be precisely described as duration. The evaluation interval for the ADSD V1.0 is, "since you got up this morning" (QSEVINTX = "SINCE GETTING UP THIS MORNING

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   ").

3. The ADSD V1.0 instrument includes a total score

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   that is considered as captured data on the CRF

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   and is not considered as derived in the example below. These scores may be submitted in SDTM or

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   derived in the Analysis Data Model (ADaM) per scoring instructions from the user manual.

   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).

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   2. If scores are received by the sponsor,

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      it is recommended that they are submitted to SDTM and verified in ADaM.

4. Terminology

   1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

   2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

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