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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.", 3 = "Severe.", 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  is populated in the RSEVLINT field the RSEVLINT field in ISO 8601 format when (or QSEVINTX, as appropriate) when the evaluation interval can be precisely described as duration. The evaluation interval for the the HAMD 17 is the past week (RSEVLINT = "-P1W"). is determined based on the sponsor's stated evaluation interval. 

3. The HAMD 17 instrument includes a total score on the CRF that is considered as captured data on the CRF and is not considered as derived in the example below.

   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 written on a CRF 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).

4. Question 16 contains 2 components, Part A “Loss of WT According to Patient” and Part B “Loss of WT According to WK Meas”. Only one of these items is answered when administering the HAMD 17 instrument. The unanswered part of is represented with missing data for the RSORRES, RSSTRESC and RSSTRESN variables with RSSTAT = "NOT DONE" and RSREASND = "NO RESPONSE COLLECTED".

   1. “Presence of Data” items missing data rule:

      1. A record is created in qs.xpt for all items.
      2. If the reason for the not done record is known, then --STAT=“NOT DONE” and --REASND=reason provided (e.g., “PREFER NOT TO ANSWER”)
      3. If the reason for the not done record is unknown, then the reason is that the response was not collected (--STAT=“NOT DONE” and --REASND=“NO RESPONSE COLLECTED”

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 is provided in Section 4, SDTM Mapping Strategy.

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The HAMD 17 example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit for the HAMD 17 instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC. The sponsor's evaluation interval for the example is the past week (RSEVLINT = "-P1W").

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