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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
Date2020-0607-1801
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
2020-0607-1801
2.1 Draft
  • The HAMD 17 v2.0 supplement was updated to the WIKI clinical classifications supplement template.
  • Annotated CRF was revised to a CDISC CRF to avoid complications with HAMD 17 CRFs included in copyrighted publications.
  • 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.
  • Section 3.1 reference to the total score of 54 was revised to 53.
  • Revised assumption 2 to to be a sponsor's stated evaluation interval. 
  • Added assumption 4 describing how question 16A and 16B are handled and included with the “Logically Skipped Item” data rule.
  • The example replaced the RSBLFL variable with RSLOBXFL, added the RSDTC variable and uses the RSTAT and RSREASND variables for the unanswered question 16B.
  • All responses were updated to end in a "." punctuation as represented on the CRF.

  • The following example row values were revised:

    • Row 3 RSTESTCD = “HAMD103 original RSORRES = “Ideas or gestures suicide.” was revised to “Ideas or gestures of suicide.”
    • Row 8 RSTESTCD = “HAMD108 original RSORRES = “Complete stupor.”  RSSTRESC = 4 and RSSTRESN = 4 was revised to RSORRES = “Slight retardation during the interview.”  RSSTRESC = 1 and RSSTRESN = 1.
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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CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.  CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

CDISC believes this believes this instrument is to be in the public domain public domain, but you should perform your own assessment. CDISC has included the HAMD 17 in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the clinical classification. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

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