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© 2019 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values (https://wiki.cdisc.org/download/attachments/92789702/HAMD%2017%20Annotated%20CRF.pdf?api=v2).. (HAMD 17 Annotated CRF.pdf)

Note: CDISC Controlled Terminology is maintained by National Cancer Institute Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology.

Reference for the Hamilton Depression Rating Scale 17-Item (HAMD 17):

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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 populated in the RSEVINTX 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  instrument includes a total score on the CRF score that is considered  considered as captured data on the CRF and is not considered as derived in the example below. This total score is considered as captured data when provided as part of Electronic Data Transfer (eDT) and is not considered as derived in the example below.

   1. If operationally defined by the sponsor, it is the sponsorIf 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 weight according to the patient” and Part B “Loss of weight according to weekly measurements”. Only one of these items is answered when administering the HAMD 17 instrument. The unanswered part of component is considered as a "logically skipped record" in the data and is represented with missing data for the RSORRES, RSSTRESC and RSSTRESN variables with null values and with RSSTAT = "NOT DONE" and RSREASND = "NO RESPONSE COLLECTED".LOGICALLY SKIPPED ITEM".

   1. A record is created in qs.xpt for all items

      “Presence of Data” items missing data rule:

   2. A record is created in qs.xpt for all items.
   3. If the reason for the not done record is known, then --STAT=“NOT DONE” and --REASND=reason provided (e.g., “PREFER NOT TO ANSWER”).
   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”)

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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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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 RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.

RSTESTCD = "HAMD101" RSTEST = "HAMD1-Depressed Mood"

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