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| Title | Hamilton Depression Rating Scale 17-Item (HAMD 17) |
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| CDISC Reference | Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Public Domain |
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| Team | Major Depressive Disorder (MDD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 2.1 |
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| Status | DRAFT |
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| Date | 2019-1112-1504 |
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| Notes | This 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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| Date | Version | Summary of Changes |
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| 2019-1112-1504 | 2.1 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.
- Added assumption 4 describing how question 16A and 16B are handled and included the “Presence of Data” items missing 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.
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| 2016-05-23 | 2.0 | - This measure was re-evaluated to fit the definition of a clinical classification measure. The domain was changed from the QS to RS domain.
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| 2013-05-15 | 1.1 | - Q16 only uses Part A or Part B and not both questions
- Revised annotated CRF to meet annotation font standards
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| 2012-08-07 | 1.0 | Final |
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This document describes the CDISC implementation of the Hamilton Depression Rating Scale 17-Item (HAMD 17) clinical classification.
CDISC does not modify clinical classifications questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.
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