SDTM Example.Vital Signs

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

Record date of measurements using this format (DD-MON-YYYY).	Date VSDAT VSDTC	_ _ / _ _ _ / _ _ _ _
Record time of measurement.	Time VSTIM VSDTC	_ _ : _ _ : _ _
Record the height result.	Height 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"	cm in <VSRESU codelist>
Record the weight result.	Weight 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"	kg LB <VSRESU codelist>
Record the temperature result.	Temperature 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"	C F <VSRESU codelist>
Record the respiratory rate result.	Respiratory Rate RESP VSORRES where VSTESTCD = "RESP"	_______
	Respiratory Rate Unit RESPU VSORRESU where VSTESTCD = "RESP" Pre-populated	breaths/min <VSRESU codelist>
Record the systolic blood pressure result.	Systolic Blood Pressure SYSBP VSORRES where VSTESTCD = "SYSBP"	_______
	Systolic Blood Pressure Unit SYSBPU VSORRESU where VSTESTCD = "SYSBP" Pre-populated	mmHg <VSRESU codelist>
Record the diastolic blood pressure result.	Diastolic Blood Pressure DIABP VSORRES where VSTESTCD = "DIABP"	_______
	Diastolic Blood Pressure Unit DIABPU VSORRESU where VSTESTCD = "DIABP" Pre-populated	mmHg <VSRESU codelist>
Record the pulse rate result.	Pulse Rate PULSE VSORRES where VSTESTCD = "PULSE"	_______
	Pulse Rate Unit PULSEU VSORRESU where VSTESTCD = "PULSE" Pre-populated	beats/min <VSRESU codelist>

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

List Style

Hidden

VSDAT

1

What was the date of the measurements?

Date

Record date of measurements using this format (DD-MON-YYYY).

Date

VSDTC

Prompt

VSTIM

2

What was the time of the measurements?

Time

Record time of measurement.

Time

VSDTC

Prompt

HEIGHT

3

What was the result of the height measurement?

Height

Record the height result.

Float

VSORRES; VSTEST; VSTESTCD

VSORRES where VSTESTCD = "HEIGHT"

Prompt

HEIGHTU

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

VSORRESU

VSORRESU where VSTESTCD = "HEIGHT"

(VSRESU)

cm; in

Prompt

WEIGHT

5

What was the result of the weight measurement?

Weight

Record the weight result.

Float

VSORRES; VSTEST; VSTESTCD

VSORRES where VSTESTCD = "WEIGHT"

Prompt

WEIGHTU

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

VSORRESU

VSORRESU where VSTESTCD = "WEIGHT"

(VSRESU)

kg; LB

Prompt

TEMP

7

What was the result of the temperature measurement?

Temperature

Record the temperature result.

Float

VSORRES; VSTEST; VSTESTCD

VSORRES where VSTESTCD = "TEMP"

Prompt

TEMPU

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

VSORRESU

VSORRESU where VSTESTCD = "TEMP"

(VSRESU)

C; F

Prompt

RESP

9

What was the result of the respiratory rate measurement?

Respiratory Rate

Record the respiratory rate result.

Integer

VSORRES; VSTEST; VSTESTCD

VSORRES where VSTESTCD = "RESP"

Prompt

RESPU

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

VSORRESU

VSORRESU where VSTESTCD = "RESP"

(VSRESU)

breaths/min

Prompt

SYSBP

11

What was the result of the systolic blood pressure measurement?

Systolic Blood Pressure

Record the systolic blood pressure result.

Integer

VSORRES; VSTEST; VSTESTCD

VSORRES where VSTESTCD = "SYSBP"

Prompt

SYSBPU

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

VSORRESU

VSORRESU where VSTESTCD = "SYSBP"

(VSRESU)

mmHg

Prompt

DIABP

13

What was the result of the diastolic blood pressure measurement?

Diastolic Blood Pressure

Record the diastolic blood pressure result.

Integer

VSORRES; VSTEST; VSTESTCD

VSORRES where VSTESTCD = "DIABP"

Prompt

DIABPU

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

VSORRESU

VSORRESU where VSTESTCD = "DIABP"

(VSRESU)

mmHg

Prompt

PULSE

15

What was the result of the pulse measurement?

Pulse Rate

Record the pulse rate result.

Integer

VSORRES; VSTEST; VSTESTCD

VSORRES where VSTESTCD = "PULSE"

Prompt

PULSEU

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

VSORRESU

VSORRESU where VSTESTCD = "PULSE"

(VSRESU)

beats/min

Prompt

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

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	ABC	VS	ABC-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	ABC	VS	ABC-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	ABC	VS	ABC-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	ABC	VS	ABC-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	ABC	VS	ABC-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	ABC	VS	ABC-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	ABC	VS	ABC-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	ABC	VS	ABC-001-001	8	WEIGHT	Weight	STANDING	90.5	kg	90.5	90.5	kg					Y	1	Baseline	1	1999-06-19	1
9	ABC	VS	ABC-001-001	9	HEIGHT	Height	STANDING	157	cm	157	157	cm					Y	1	Baseline	1	1999-06-19	1
10	ABC	VS	ABC-001-001	10	SYSBP	Systolic Blood Pressure	SITTING	95	mmHg	95	95	mmHg			ARM	LEFT		2	Visit 2	35	1999-07-21	33
11	ABC	VS	ABC-001-001	11	DIABP	Diastolic Blood Pressure	SITTING	44	mmHg	44	44	mmHg			ARM	LEFT		2	Visit 2	35	1999-07-21	33
12	ABC	VS	ABC-001-001	12	TEMP	Temperature		97.16	F	36.2	36.2	C			SUBLINGUAL REGION			2	Visit 2	35	1999-07-21	33
13	ABC	VS	ABC-001-001	13	WEIGHT	Weight							NOT DONE	SUBJECT REFUSED				2	Visit 2	35	1999-07-21	33

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SDTM Example.Vital Signs