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Title

Hamilton Depression Rating Scale 17-Item (HAMD 17)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

HAMD 17

QRS Permission StatusPublic Domain
TeamMajor Depressive Disorder (MDD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.1
StatusDRAFT
Date2019-11-1315
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


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DateVersionSummary of Changes
2019-11-13152.1 Draft
  • The HAMD 17 v2.0 supplement was updated to the WIKI clinical classifications supplement template.
  • The RSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
  • The example replaced the RSBLFL variable with RSLOBXFL and added the RSDTC variable.
  • All responses were updated to end in a "." punctuation as represented on the CRF.
2016-05-232.0
  • This measure was re-evaluated to fit the definition of a clinical classification measure.  The domain was changed from the QS to RS domain.
2013-05-151.1
  • Q16 only uses Part A or Part B and not both questions
  • Revised annotated CRF to meet annotation font standards
2012-08-071.0

Final

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  1. The scale points include a numeric rating (0-2 or 0-4) and a definition of what is represented by the rating (e.g., 0 = "Absent", 2 = "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 RSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the HAMD 17 is the past week (RSEVLINT = "-P1W").

  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 contains 2 components, Part A “Loss of WT According to Patient” and Part B “Loss of WT According to WK Meas”.   Only one of the questions these items is answered when administering the HAMD-17 questionnaire.  In this example Part A is answered and Part B is shown for illustration purposes only with RSORRES=XXX, RSSTRESC=XXX and RSSTRESN=XXXinstrument. 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".

  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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