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Dataset wrap

Name	rs

Rowcaps

Rows 1-12:	Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX".	Represent the questions from the Comfort-B Scale for subject 2324-P0001 at visit 1. Row 4 represents the conditional branching item for the item "Crying". Only the first evaluation is represented (RSREPNUM=1).
Rows 13-24:	Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX".	Row 33:	The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRFRepresent the missing data from the Comfort-B Scale for subject 2324-P0001 at visit 2. The subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, and no date is assumed for when the visit would have occurred. Only the first evaluation is represented (RSREPNUM=1).

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSSTRESN	RSSTAT	RSMETHOD	RSLOBXFL	RSREPNUM	VISITNUM	RSDTC
1	STUDYX	RS	2324-P0001	1	CBS0101	CBS01-Alertness	COMFORT-B SCALE	lightly asleep (eyes mostly closed, occasional responses)	2	2			Y	1	1	2023-05-15
2	STUDYX	RS	2324-P0001	2	CBS0102	CBS01-Calmness/Agitation	COMFORT-B SCALE	slightly anxious (child shows slight anxiety)	2	2			Y	1	1	2023-05-15
3	STUDYX	RS	2324-P0001	3	CBS0103	CBS01-Respiratory Response	COMFORT-B SCALE	no spontaneous respiration	1	1			Y	1	1	2023-05-15
4	STUDYX	RS	2324-P0001	4	CBS0104	CBS01-Crying	COMFORT-B SCALE						Y	1	1	2023-05-15
5	STUDYX	RS	2324-P0001	5	CBS0105	CBS01-Physical Movement	COMFORT-B SCALE	occasional, (three or fewer) slight movements	2	2			Y	1	1	2023-05-15
6	STUDYX	RS	2324-P0001	6	CBS0106	CBS01-Muscle Tone	COMFORT-B SCALE	normal muscle tone	3	3			Y	1	1	2023-05-15
7	STUDYX	RS	2324-P0001	7	CBS0107	CBS01-Facial Tension	COMFORT-B SCALE	normal facial tone	2	2			Y	1	1	2023-05-15
8	STUDYX	RS	2324-P0001	8	CBS0108	CBS01-Total Score	COMFORT-B SCALE	12	12	12			Y	1	1	2023-05-15
9	STUDYX	RS	2324-P0001	9	CBS0109	CBS01-NRS Pain	COMFORT-B SCALE	5	5	5		NUMERICAL RATING SCALE 11-POINT	Y	1	1	2023-05-15
10	STUDYX	RS	2324-P0001	10	CBS0110	CBS01-NISS	COMFORT-B SCALE	2	2	2			Y	1	1	2023-05-15
11	STUDYX	RS	2324-P0001	11	CBS0111	CBS01-Details Sedatives/Analgesics	COMFORT-B SCALE	Midazolam	Midazolam				Y	1	1	2023-05-15
12	STUDYX	RS	2324-P0001	12	CBS0112	CBS01-Reason Assessment	COMFORT-B SCALE	Post surgery follow-up	Post surgery follow-up				Y	1	1	2023-05-15
13	STUDYX	RS	2324-P0001	1	CBS0101	CBS01-Alertness	COMFORT-B SCALE				NOT DONE			1	2
14	STUDYX	RS	2324-P0001	2	CBS0102	CBS01-Calmness/Agitation	COMFORT-B SCALE				NOT DONE			1	2
15	STUDYX	RS	2324-P0001	3	CBS0103	CBS01-Respiratory Response	COMFORT-B SCALE				NOT DONE			1	2
16	STUDYX	RS	2324-P0001	4	CBS0104	CBS01-Crying	COMFORT-B SCALE				NOT DONE			1	2
17	STUDYX	RS	2324-P0001	5	CBS0105	CBS01-Physical Movement	COMFORT-B SCALE				NOT DONE			1	2
18	STUDYX	RS	2324-P0001	6	CBS0106	CBS01-Muscle Tone	COMFORT-B SCALE				NOT DONE			1	2
19	STUDYX	RS	2324-P0001	7	CBS0107	CBS01-Facial Tension	COMFORT-B SCALE				NOT DONE			1	2
20	STUDYX	RS	2324-P0001	8	CBS0108	CBS01-Total Score	COMFORT-B SCALE				NOT DONE			1	2
21	STUDYX	RS	2324-P0001	9	CBS0109	CBS01-NRS Pain	COMFORT-B SCALE				NOT DONE			1	2
22	STUDYX	RS	2324-P0001	10	CBS0110	CBS01-NISS	COMFORT-B SCALE				NOT DONE			1	2
23	STUDYX	RS	2324-P0001	11	CBS0111	CBS01-Details Sedatives/Analgesics	COMFORT-B SCALE				NOT DONE			1	2
24	STUDYX	RS	2324-P0001	12	CBS0112	CBS01-Reason Assessment	COMFORT-B SCALE				NOT DONE			1	2

Info

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The standard terminology for QNAM and QLABEL are listed below.

The SUPPRS dataset shows the conditional branched items in the RS dataset which have assigned responses (QSCBRFL = "Y").

The anchor range text and numeric values for data collection are represented in SUPPQSThe ~~evaluation interval t~~ext value for data collection needs to be populated in SUPPRS as follows. The standard terminology for QNAM, QLABEL, and QLABEL QVAL are listed belowrepresented.

Dataset wrap

Name	supprs

STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
STUDYX	RS	2324-P0001	RSSEQ	4	RSCBRFL	Conditionally Branched Item Flag	Y	CRF
STUDYX	RS	2324-P0001	RSTESTCD	CBS0109	RSANTXLO	Anchor Text Low	no pain	CRF
STUDYX	RS	2324-P0001	RSTESTCD	CBS0109	RSANTXHI	Anchor Text High	worst pain possible	CRF
STUDYX	RS	2324-P0001	RSTESTCD	CBS0109	RSANVLLO	Anchor Value Low	0	CRF
STUDYX	RS	2324-P0001	RSTESTCD	CBS0109	RSANVLHI	Anchor Value High	10	CRF

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