Vital Signs (VS)

Vital Signs (VS) is a Findings domain used to represent vital signs measurements, including (but not limited) to blood pressure, temperature, respiration, body surface area, BMI, height, and weight.

Example

This is an example of a CRF used to collect vital signs.

Order	Question Text	Prompt	CRF Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology Code List Name	Permissible Values	Pre-Populated Value
1	What was the date of the measurements?	Date	Record date of measurements.	Date	VSDAT	VSDTC
2	What was the time of the measurements?	Time	Record time of measurement.	Time	VSTIM	VSDTC
3	What was the result of the height measurement?	Height	Record the height result.	Float	HEIGHT	VSORRES	VSORRES where VSTESTCD = "HEIGHT"
4	What was the unit of the height measurement?	Height Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	HEIGHTU	VSORRESU	VSORRESU where VSTESTCD = "HEIGHT"	(VSRESU)	centimeter; iinch
5	What was the result of the weight measurement?	Weight	Record the weight result.	Float	WEIGHT	VSORRESS
6	What was the unit of the weight measurement?	Weight Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	WEIGHTU	VSORRESU	VSORRESU where VSTESTCD = "WEIGHT"	(VSRESU)	kilogram; Pound
7	What was the result of the temperature measurement?	Temperature	Record the temperature result.	Float	TEMP	VSORRES	VSORRES where VSTESTCD = "TEMP"
8	What was the unit of the temperature measurement?	Temperature Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	TEMPU	VSORRESU	VSORRESU where VSTESTCD = "TEMP"	(VSRESU)	Celsius; Fahrenheit
9	What was the result of the respiratory rate measurement?	Respiratory Rate	Record the respiratory rate result.	Float	RESP	VSORRES	VSORRES where VSTESTCD = "RESP"
10	What was the unit of the respiratory rate measurement?	Respiratory Rate Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	RESPU	VSORRESU	VSORRESU where VSTESTCD = "RESP"	(VSRESU)		breaths/min
11	What was the result of the systolic blood pressure measurement?	Systolic Blood Pressure	Record the systolic blood pressure result.	Integer	SYSBP	VSORRES	VSORRES where VSTESTCD = "SYSBP"
12	What was the unit of the systolic blood pressure measurement?	Systolic Blood Pressure Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	SYSBPU	VSORRESU	VSORRESU where VSTESTCD = "SYSBP"	(VSRESU)		mmHg
13	What was the result of the diastolic blood pressure measurement?	Diastolic Blood Pressure	Record the diastolic blood pressure result.	Integer	DIABP	VSORRES	VSORRES where VSTESTCD = "DIABP"
14	What was the unit of the diastolic blood pressure measurement?	Diastolic Blood Pressure Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	DIABPU	VSORRESU	VSORRESU where VSTESTCD = "DIABP"	(VSRESU)		mmHg
15	What was the result of the pulse measurement?	Pulse Rate	Record the pulse rate result.	Integer	PULSE	VSORRES	VSORRES where VSTESTCD = "PULSE"
16	What was the unit of the pulse rate measurement?	Pulse Rate Unit	Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Text	PULSEU	VSORRESU	VSORRESU where VSTESTCD = "PULSE"	(VSRESU)		beats/min

This is an example of the SDTM VS domain.

Rows 1-4, 6-7:	VSTPT and VSTPTNUM are populated because more than 1 measurement was taken at this visit.
Rows 2, 4-5, 7-9:	VSLOBXFL="Y" indicates that the observation was used as the last observation before exposure measurement.
Rows 10-11:	Show blood pressure observations obtained at visit 2.
Row 12:	Shows a value collected in one unit, but converted to selected standard unit.
Row 13:	Shows the proper use of the --STAT variable to indicate "NOT DONE" where a reason was collected when a test was not done.

vs.xpt

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Row	STUDYID	DOMAIN	USUBJID	VSSEQ	VSTESTCD	VSTEST	VSPOS	VSORRES	VSORRESU	VSSTRESC	VSSTRESN	VSSTRESU	VSSTAT	VSREASND	VSLOC	VSLAT	VSLOBXFL	VISITNUM	VISIT	VISITDY	VSDTC	VSDY	VSTPT	VSTPTNUM
1	ABCVS	VS	ABCVS-001-001	1	SYSBP	Systolic Blood Pressure	SITTING	154	mmHg	154	154	mmHg			ARM	LEFT		1	Baseline	1	1999-06-19T08:45	1	BASELINE 1	1
2	ABCVS	VS	ABCVS-001-001	2	SYSBP	Systolic Blood Pressure	SITTING	152	mmHg	152	152	mmHg			ARM	LEFT	Y	1	Baseline	1	1999-06-19T09:00	1	BASELINE 2	2
3	ABCVS	VS	ABCVS-001-001	3	DIABP	Diastolic Blood Pressure	SITTING	44	mmHg	44	44	mmHg			ARM	LEFT		1	Baseline	1	1999-06-19T08:45	1	BASELINE 1	1
4	ABCVS	VS	ABCVS-001-001	4	DIABP	Diastolic Blood Pressure	SITTING	48	mmHg	48	48	mmHg			ARM	LEFT	Y	1	Baseline	1	1999-06-19T09:00	1	BASELINE 2	2
5	ABCVS	VS	ABCVS-001-001	5	PULSE	Pulse Rate	SITTING	72	beats/min	72	72	beats/min			ARM	LEFT	Y	1	Baseline	1	1999-06-19	1
6	ABCVS	VS	ABCVS-001-001	6	TEMP	Temperature		34.7	C	34.7	34.7	C			SUBLINGUAL REGION			1	Baseline	1	1999-06-19T08:45	1	BASELINE 1	1
7	ABCVS	VS	ABCVS-001-001	7	TEMP	Temperature		36.2	C	36.2	36.2	C			SUBLINGUAL REGION		Y	1	Baseline	1	1999-06-19T09:00	1	BASELINE 2	2
8	ABCVS	VS	ABCVS-001-001	8	WEIGHT	Weight		90.5	kg	90.5	90.5	kg					Y	1	Baseline	1	1999-06-19	1
9	ABCVS	VS	ABCVS-001-001	9	HEIGHT	Height		157	cm	157	157	cm					Y	1	Baseline	1	1999-06-19	1
10	ABCVS	VS	ABCVS-001-001	10	SYSBP	Systolic Blood Pressure	SITTING	95	mmHg	95	95	mmHg			ARM	LEFT		2	Visit 2	35	1999-07-21	33
11	ABCVS	VS	ABCVS-001-001	11	DIABP	Diastolic Blood Pressure	SITTING	44	mmHg	44	44	mmHg			ARM	LEFT		2	Visit 2	35	1999-07-21	33
12	ABCVS	VS	ABCVS-001-001	12	TEMP	Temperature		97.16	F	36.2	36.2	C			SUBLINGUAL REGION			2	Visit 2	35	1999-07-21	33
13	ABCVS	VS	ABCVS-001-001	13	WEIGHT	Weight							NOT DONE	SUBJECT REFUSED				2	Visit 2	35	1999-07-21	33

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Vital Signs (VS)