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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. 

OrderQuestion TextPromptCRF Completion InstructionsTypeCollection Variable Tabulation  Target Mapping InstructionsControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1What was the date of the measurements?DateRecord date of measurements. DateVSDATVSDTC



2What was the time of the measurements?TimeRecord time of measurement.TimeVSTIMVSDTC



3What was the result of the height measurement?HeightRecord the height result.FloatHEIGHTVSORRES VSORRES where VSTESTCD = "HEIGHT"


4What was the unit of the height measurement?Height UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextHEIGHTUVSORRESUVSORRESU where VSTESTCD = "HEIGHT"(VSRESU)centimeter;  iinch
5What was the result of the weight measurement?WeightRecord the weight result.FloatWEIGHTVSORRESS



6What was the unit of the weight measurement?Weight UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextWEIGHTUVSORRESUVSORRESU where VSTESTCD = "WEIGHT"(VSRESU)kilogram; Pound
7What was the result of the temperature measurement?TemperatureRecord the temperature result.FloatTEMPVSORRES  VSORRES where VSTESTCD = "TEMP"


8What was the unit of the temperature measurement?Temperature UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextTEMPUVSORRESUVSORRESU where VSTESTCD = "TEMP"(VSRESU)Celsius; Fahrenheit
9What was the result of the respiratory rate measurement?Respiratory RateRecord the respiratory rate result.FloatRESPVSORRES  VSORRES where VSTESTCD = "RESP"


10What was the unit of the respiratory rate measurement?Respiratory Rate UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextRESPUVSORRESUVSORRESU where VSTESTCD = "RESP"(VSRESU)
breaths/min
11What was the result of the systolic blood pressure measurement?Systolic Blood PressureRecord the systolic blood pressure result.IntegerSYSBPVSORRES  VSORRES where VSTESTCD = "SYSBP"


12What was the unit of the systolic blood pressure measurement?Systolic Blood Pressure UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextSYSBPUVSORRESUVSORRESU where VSTESTCD = "SYSBP"(VSRESU)
mmHg
13What was the result of the diastolic blood pressure measurement?Diastolic Blood PressureRecord the diastolic blood pressure result.IntegerDIABPVSORRES  VSORRES where VSTESTCD = "DIABP"


14What was the unit of the diastolic blood pressure measurement?Diastolic Blood Pressure UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextDIABPUVSORRESUVSORRESU where VSTESTCD = "DIABP"(VSRESU)
mmHg
15What was the result of the pulse measurement?Pulse RateRecord the pulse rate result.IntegerPULSEVSORRES  VSORRES where VSTESTCD = "PULSE"


16What was the unit of the pulse rate measurement?Pulse Rate UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextPULSEUVSORRESUVSORRESU 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

xx.xpt

RowSTUDYIDDOMAINUSUBJIDVSSEQVSTESTCDVSTESTVSPOSVSORRESVSORRESUVSSTRESCVSSTRESNVSSTRESUVSSTATVSREASNDVSLOCVSLATVSLOBXFLVISITNUMVISITVISITDYVSDTCVSDYVSTPTVSTPTNUM
1ABCVSVSABCVS-001-0011SYSBPSystolic Blood PressureSITTING154mmHg154154mmHg

ARMLEFT
1Baseline11999-06-19T08:451BASELINE 11
2ABCVSVSABCVS-001-0012SYSBPSystolic Blood PressureSITTING152mmHg152152mmHg

ARMLEFTY1Baseline11999-06-19T09:001BASELINE 22
3ABCVSVSABCVS-001-0013DIABPDiastolic Blood PressureSITTING44mmHg4444mmHg

ARMLEFT
1Baseline11999-06-19T08:451BASELINE 11
4ABCVSVSABCVS-001-0014DIABPDiastolic Blood PressureSITTING48mmHg4848mmHg

ARMLEFTY1Baseline11999-06-19T09:001BASELINE 22
5ABCVSVSABCVS-001-0015PULSEPulse RateSITTING72beats/min7272beats/min

ARMLEFTY1Baseline11999-06-191

6ABCVSVSABCVS-001-0016TEMPTemperature
34.7C34.734.7C

SUBLINGUAL REGION

1Baseline11999-06-19T08:451BASELINE 11
7ABCVSVSABCVS-001-0017TEMPTemperature
36.2C36.236.2C

SUBLINGUAL REGION
Y1Baseline11999-06-19T09:001BASELINE 22
8ABCVSVSABCVS-001-0018WEIGHTWeight
90.5kg90.590.5kg



Y1Baseline11999-06-191

9ABCVSVSABCVS-001-0019HEIGHTHeight
157cm157157cm



Y1Baseline11999-06-191

10ABCVSVSABCVS-001-00110SYSBPSystolic Blood PressureSITTING95mmHg9595mmHg

ARMLEFT
2Visit 2351999-07-2133

11ABCVSVSABCVS-001-00111DIABPDiastolic Blood PressureSITTING44mmHg4444mmHg

ARMLEFT
2Visit 2351999-07-2133

12ABCVSVSABCVS-001-00112TEMPTemperature
97.16F36.236.2C

SUBLINGUAL REGION

2Visit 2351999-07-2133

13ABCVSVSABCVS-001-00113WEIGHTWeight





NOT DONESUBJECT REFUSED


2Visit 2351999-07-2133

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