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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
This CDISC believes this instrument is in the public domain. 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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Reference for the Hamilton Depression Rating Scale 17-Item (HAMD 17):
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Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56–62.
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| Row 16: | Represents question 16 Part A when the subject answered the weight loss according to the patient. | | Row 17: | Represents question 16 Part B as a logically skipped item when the 16 Part A item is answered. | | Row 19: | Represents the total score. All total scores are considered as captured data unless the sponsor operationally derives it via an EDC system.
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| ROW | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSSTAT | RSREASND | RSLOBXFL | VISITNUM | RSDTC | RSEVLINT | | 1 | STUDYX | RS | 2324-P0001 | 1 | HAMD101 | HAMD1-Depressed Mood | HAMD 17 | Absent. | 0 | 0 | | | Y | 1 | 2019-11-16 | -P1W | | 2 | STUDYX | RS | 2324-P0001 | 2 | HAMD102 | HAMD1-Feelings of Guilt | HAMD 17 | Self reproach, feels he/she has let people down. | 1 | 1 | | | Y | 1 | 2019-11-16 | -P1W | | 3 | STUDYX | RS | 2324-P0001 | 3 | HAMD103 | HAMD1-Suicide | HAMD 17 | Ideas or gestures of suicide. | 3 | 3 | | | Y | 1 | 2019-11-16 | -P1W | | 4 | STUDYX | RS | 2324-P0001 | 4 | HAMD104 | HAMD1-Insomnia Early - Early Night | HAMD 17 | No difficulty falling asleep. | 0 | 0 | | | Y | 1 | 2019-11-16 | -P1W | | 5 | STUDYX | RS | 2324-P0001 | 5 | HAMD105 | HAMD1-Insomnia Middle - Middle Night | HAMD 17 | No difficulty. | 0 | 0 | | | Y | 1 | 2019-11-16 | -P1W | | 6 | STUDYX | RS | 2324-P0001 | 6 | HAMD106 | HAMD1-Insomnia Early Hours -Morning | HAMD 17 | No difficulty. | 0 | 0 | | | Y | 1 | 2019-11-16 | -P1W | | 7 | STUDYX | RS | 2324-P0001 | 7 | HAMD107 | HAMD1-Work and Activities | HAMD 17 | No difficulty. | 0 | 0 | | | Y | 1 | 2019-11-16 | -P1W | | 8 | STUDYX | RS | 2324-P0001 | 8 | HAMD108 | HAMD1-Retardation | HAMD 17 | Slight retardation during the interview. | 1 | 1 | | | Y | 1 | 2019-11-16 | -P1W | | 9 | STUDYX | RS | 2324-P0001 | 9 | HAMD109 | HAMD1-Agitation | HAMD 17 | Fidgetiness. | 1 | 1 | | | Y | 1 | 2019-11-16 | -P1W | | 10 | STUDYX | RS | 2324-P0001 | 10 | HAMD110 | HAMD1-Anxiety Psychic | HAMD 17 | No difficulty. | 0 | 0 | | | Y | 1 | 2019-11-16 | -P1W | | 11 | STUDYX | RS | 2324-P0001 | 11 | HAMD111 | HAMD1-Anxiety Somatic | HAMD 17 | Moderate. | 2 | 2 | | | Y | 1 | 2019-11-16 | -P1W | | 12 | STUDYX | RS | 2324-P0001 | 12 | HAMD112 | HAMD1-Somatic Symptoms GI | HAMD 17 | None. | 0 | 0 | | | Y | 1 | 2019-11-16 | -P1W | | 13 | STUDYX | RS | 2324-P0001 | 13 | HAMD113 | HAMD1-General Somatic Symptoms | HAMD 17 | None. | 0 | 0 | | | Y | 1 | 2019-11-16 | -P1W | | 14 | STUDYX | RS | 2324-P0001 | 14 | HAMD114 | HAMD1-Genital Symptoms | HAMD 17 | Mild. | 1 | 1 | | | Y | 1 | 2019-11-16 | -P1W | | 15 | STUDYX | RS | 2324-P0001 | 15 | HAMD115 | HAMD1-Hypochondriasis | HAMD 17 | Not present. | 0 | 0 | | | Y | 1 | 2019-11-16 | -P1W | | 16 | STUDYX | RS | 2324-P0001 | 16 | HAMD116A | HAMD1-Loss of WT According to Patient | HAMD 17 | Definite (according to patient) weight loss. | 2 | 2 | | | Y | 1 | 2019-11-16 | -P1W | | 17 | STUDYX | RS | 2324-P0001 | 17 | HAMD116B | HAMD1-Loss of WT According to WK Meas | HAMD 17 | | | | NOT DONE | LOGICALLY SKIPPED ITEM | Y | 1 | 2019-11-16 | -P1W | | 18 | STUDYX | RS | 2324-P0001 | 18 | HAMD117 | HAMD1-Insight | HAMD 17 | Denies being ill at all. | 2 | 2 | | | Y | 1 | 2019-11-16 | -P1W | | 19 | STUDYX | RS | 2324-P0001 | 19 | HAMD118 | HAMD1-Total Score | HAMD 17 | 16 | 16 | 16 | | | Y | 1 | 2019-11-16 | -P1W |
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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.
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