Vital Signs

The Vital Signs (VS) domain is based on the Findings General Observation class. The (VS domain is used to represent vital signs measurements, including, but not limited, to blood pressure, temperature, respiration, body surface area, body mass index (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