Page History

...

Page properties

Title	Hamilton Depression Rating Scale 17-Item (HAMD 17)
CDISC Reference	Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name	HAMD 17
QRS Permission Status	Public Domain
Team	Major Depressive Disorder (MDD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version	2.1
Status	DRAFT
Date	2020-07-0715
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.

...

Date	Version	Summary of Changes
2020-07-0715	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. Updated the data example to include a missing visit 2 set of NOT DONE records.
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.
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
2012-08-07	1.0	Final

...

The HAMD 17 example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit and a visit 2 represented as not being collected for the HAMD 17 instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC. The sponsor's evaluation interval for the example is the past week (RSEVLINT = "-P1W").

...

Dataset wrap

Name	rs

Rowcaps

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.

Dataset2

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

			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

Y1

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

20

STUDYX

RS

2324-P0001

20

HAMD101

HAMD1-Depressed Mood

HAMD 17

NOT DONE

2

2019-11-23

-P1W

21

STUDYX

RS

2324-P0001

21

HAMD102

HAMD1-Feelings of Guilt

HAMD 17

NOT DONE

2

2019-11-23

-P1W

22

STUDYX

RS

2324-P0001

22

HAMD103

HAMD1-Suicide

HAMD 17

NOT DONE

2

2019-11-23

-P1W

23

STUDYX

RS

2324-P0001

23

HAMD104

HAMD1-Insomnia Early - Early Night

HAMD 17

NOT DONE

2

2019-11-23

-P1W

24

STUDYX

RS

2324-P0001

24

HAMD105

HAMD1-Insomnia Middle - Middle Night

HAMD 17

NOT DONE

2

2019-11-23

-P1W

25

STUDYX

RS

2324-P0001

25

HAMD106

HAMD1-Insomnia Early Hours -Morning

HAMD 17

NOT DONE

2

2019-11-23

-P1W

26

STUDYX

RS

2324-P0001

26

HAMD107

HAMD1-Work and Activities

HAMD 17

NOT DONE

2

2019-11-23

-P1W

27

STUDYX

RS

2324-P0001

27

HAMD108

HAMD1-Retardation

HAMD 17

NOT DONE

2

2019-11-23

-P1W

28

STUDYX

RS

2324-P0001

28

HAMD109

HAMD1-Agitation

HAMD 17

NOT DONE

2

2019-11-23

-P1W

29

STUDYX

RS

2324-P0001

29

HAMD110

HAMD1-Anxiety Psychic

HAMD 17

NOT DONE

2

2019-11-23

-P1W

30

STUDYX

RS

2324-P0001

30

HAMD111

HAMD1-Anxiety Somatic

HAMD 17

NOT DONE

2

2019-11-23

-P1W

31

STUDYX

RS

2324-P0001

31

HAMD112

HAMD1-Somatic Symptoms GI

HAMD 17

NOT DONE

2

2019-11-23

-P1W

32

STUDYX

RS

2324-P0001

32

HAMD113

HAMD1-General Somatic Symptoms

HAMD 17

NOT DONE

2

2019-11-23

-P1W

33

STUDYX

RS

2324-P0001

33

HAMD114

HAMD1-Genital Symptoms

HAMD 17

NOT DONE

2

2019-11-23

-P1W

34

STUDYX

RS

2324-P0001

34

HAMD115

HAMD1-Hypochondriasis

HAMD 17

NOT DONE

2

2019-11-23

-P1W

35

STUDYX

RS

2324-P0001

35

HAMD116A

HAMD1-Loss of WT According to Patient

HAMD 17

NOT DONE

2

2019-11-23

-P1W

36

STUDYX

RS

2324-P0001

36

HAMD116B

HAMD1-Loss of WT According to WK Meas

HAMD 17

NOT DONE

2

2019-11-23

-P1W

37

STUDYX

RS

2324-P0001

37

HAMD117

HAMD1-Insight

HAMD 17

NOT DONE

2

2019-11-23

-P1W

38

STUDYX

RS

2324-P0001

38

HAMD118

HAMD1-Total Score

HAMD 17

NOT DONE

2

2019-11-23

-P1W

Page tree

Versions Compared

Old Version 62

New Version 63

Key

4 SDTM Mapping Strategy