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1. The scale points include a numeric rating (0-2, 0-3, or 0-4) and a definition of what is represented by the rating (e.g., 0 = "Absent.", 4 = "Incapacitating."). For the HAMD 17, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.

2. The time period of evaluation for the HAMD 17 is populated in the RSEVLINT field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the HAMD 17 is determined based on the sponsor's stated evaluation interval.

3. The HAMD 17 instrument includes a total score that is considered as captured data on the CRF and is not considered as derived in the example below. This score may be submitted in SDTM or derived in the Analysis Data Model (ADaM).

   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.

4. Item 16 contains 2 components: Part A, which is loss of weight according to the patient and Part B, which is loss of weight according to weekly measurements. Only 1 of these items is answered when administering the HAMD 17 instrument. A record is created in rs.xpt for all items. The unanswered component is considered as a logically skipped item in the data and is represented as follows:

   1. RSSTAT = "NOT DONE".

   2. RSREASND = "LOGICALLY SKIPPED ITEM".
      

   3. RSORRES, RSSTRESC, and RSSTRESN are set to null.

5. Terminology

   1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

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

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