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


Record date of measurements using this format (DD-MON-YYYY).
VSDAT VSDTC
_ _ / _ _ _ / _ _ _ _
Record time of measurement.
VSTIM VSDTC
_ _ : _ _ : _ _
Record the height result.
HEIGHT VSORRES where VSTESTCD = "HEIGHT"
_______
Record or select the original unit in which these data were collected, if not pre-printed on CRF.Height Unit
HEIGHTU VSORRESU where VSTESTCD = "HEIGHT"
<VSRESU codelist>
Record the weight result.
WEIGHT VSORRES where VSTESTCD = "WEIGHT"
_______
Record or select the original unit in which these data were collected, if not pre-printed on CRF.Weight Unit
WEIGHTU VSORRESU where VSTESTCD = "WEIGHT"
<VSRESU codelist>
Record the temperature result.
TEMP VSORRES where VSTESTCD = "TEMP"
_______
Record or select the original unit in which these data were collected, if not pre-printed on CRF.Temperature Unit
TEMPU VSORRESU where VSTESTCD = "TEMP"
<VSRESU codelist>
Record the respiratory rate result.
RESP VSORRES where VSTESTCD = "RESP"
_______
RESPU VSORRESU where VSTESTCD = "RESP"
Pre-populated
breaths/min
<VSRESU codelist>
Record the systolic blood pressure result.
SYSBP VSORRES where VSTESTCD = "SYSBP"
_______
SYSBPU VSORRESU where VSTESTCD = "SYSBP"
Pre-populated
mmHg
<VSRESU codelist>
Record the diastolic blood pressure result.
DIABP VSORRES where VSTESTCD = "DIABP"
_______
DIABPU VSORRESU where VSTESTCD = "DIABP"
Pre-populated
mmHg
<VSRESU codelist>
Record the pulse rate result.
PULSE VSORRES where VSTESTCD = "PULSE"
_______
PULSEU VSORRESU where VSTESTCD = "PULSE"
Pre-populated
beats/min
<VSRESU codelist>
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
VSDAT1What was the date of the measurements?DateRecord date of measurements using this format (DD-MON-YYYY).DateVSDTC



Prompt

VSTIM2What was the time of the measurements?TimeRecord time of measurement.TimeVSDTC



Prompt

HEIGHT3What was the result of the height measurement?HeightRecord the height result.FloatVSORRES;  VSTEST;  VSTESTCDVSORRES where VSTESTCD = "HEIGHT"


Prompt

HEIGHTU4What 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.TextVSORRESUVSORRESU where VSTESTCD = "HEIGHT"(VSRESU)cm; in
Prompt

WEIGHT5What was the result of the weight measurement?WeightRecord the weight result.FloatVSORRES;  VSTEST;  VSTESTCDVSORRES where VSTESTCD = "WEIGHT"


Prompt

WEIGHTU6What 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.TextVSORRESUVSORRESU where VSTESTCD = "WEIGHT"(VSRESU)kg; LB
Prompt

TEMP7What was the result of the temperature measurement?TemperatureRecord the temperature result.FloatVSORRES;  VSTEST;  VSTESTCDVSORRES where VSTESTCD = "TEMP"


Prompt

TEMPU8What 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.TextVSORRESUVSORRESU where VSTESTCD = "TEMP"(VSRESU)C; F
Prompt

RESP9What was the result of the respiratory rate measurement?Respiratory RateRecord the respiratory rate result.IntegerVSORRES;  VSTEST;  VSTESTCDVSORRES where VSTESTCD = "RESP"


Prompt

RESPU10What 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.TextVSORRESUVSORRESU where VSTESTCD = "RESP"(VSRESU)
breaths/minPrompt

SYSBP11What was the result of the systolic blood pressure measurement?Systolic Blood PressureRecord the systolic blood pressure result.IntegerVSORRES;  VSTEST;  VSTESTCDVSORRES where VSTESTCD = "SYSBP"


Prompt

SYSBPU12What 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.TextVSORRESUVSORRESU where VSTESTCD = "SYSBP"(VSRESU)
mmHgPrompt

DIABP13What was the result of the diastolic blood pressure measurement?Diastolic Blood PressureRecord the diastolic blood pressure result.IntegerVSORRES;  VSTEST;  VSTESTCDVSORRES where VSTESTCD = "DIABP"


Prompt

DIABPU14What 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.TextVSORRESUVSORRESU where VSTESTCD = "DIABP"(VSRESU)
mmHgPrompt

PULSE15What was the result of the pulse measurement?Pulse RateRecord the pulse rate result.IntegerVSORRES;  VSTEST;  VSTESTCDVSORRES where VSTESTCD = "PULSE"


Prompt

PULSEU16What 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.TextVSORRESUVSORRESU where VSTESTCD = "PULSE"(VSRESU)
beats/minPrompt

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
1ABCVSABC-001-0011SYSBPSystolic Blood PressureSITTING154mmHg154154mmHg

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

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

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

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

ARMLEFTY1Baseline11999-06-191

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

SUBLINGUAL REGION

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

SUBLINGUAL REGION
Y1Baseline11999-06-19T09:001BASELINE 22
8ABCVSABC-001-0018WEIGHTWeightSTANDING90.5kg90.590.5kg



Y1Baseline11999-06-191

9ABCVSABC-001-0019HEIGHTHeightSTANDING157cm157157cm



Y1Baseline11999-06-191

10ABCVSABC-001-00110SYSBPSystolic Blood PressureSITTING95mmHg9595mmHg

ARMLEFT
2Visit 2351999-07-2133

11ABCVSABC-001-00111DIABPDiastolic Blood PressureSITTING44mmHg4444mmHg

ARMLEFT
2Visit 2351999-07-2133

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

SUBLINGUAL REGION

2Visit 2351999-07-2133

13ABCVSABC-001-00113WEIGHTWeight





NOT DONESUBJECT REFUSED


2Visit 2351999-07-2133

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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