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Dataset wrap
Namevs
Dataset2

Row

STUDYID

DOMAIN

USUBJID

VSSEQ

VSLNKID

VSTESTCD

VSTEST

VSORRES

VSORRESU

VSSTRESC

VSSTRESN

VSSTRESU

VSLOC

VSBLFL

VISITNUM

VSDTC

1STUDYXVSP00011AP01TEMPTemperature38.9C38.938.9CRECTUMY12014-06-24
2STUDYXVSP00012AP02MAPMean Arterial Pressure117mmHg117117mmHg
Y12014-06-24
3STUDYXVSP00013AP03HRHeart Rate98beats/min9898beats/min
Y12014-06-24
4STUDYXVSP00014AP04RESPRespiratory Rate54breaths/min5454breaths/min
Y12014-06-24
Dataset wrap
Rowcaps
Rows 1-4:

Represent diabetes and rheumatoid arthritis medical history used to calculate the risk scores for subject 1001-001 shown in the RS domain above.

Rows 5-6:

Represent diabetes and rheumatoid arthritis medical history used to calculate the risk score for subject 1001-002 shown in the RS domain above.

Dataset wrap
Namesu
Rowcaps
Rows 1-2:

Represent smoking information used to calculate the risk scores for subject 1001-001 shown in the RS domain above.

Row 3:

Represents smoking information used to calculate the risk score for subject1001-002 shown in the RS domain above.

Dataset2
tableidsu
RowSTUDYIDDOMAINUSUBJIDSUSEQSULNKIDSUTRTSUCATSUDOSESUDOSUSUDOSFQSUSTRTPTSUSTTPTSUENRTPTSUENTPTSUPRESPSUOCCURVISITNUMVISITSUDTC
11001SU1001-00111CIGARETTESTOBACCO0CIGARETTEPER DAY



YN1VISIT 12012-05-10
21001SU1001-00122CIGARETTESTOBACCO5CIGARETTEPER DAYBEFORE2012-10-08ONGOING2012-10-08YY5VISIT 52012-10-08
31001SU1001-00211CIGARETTESTOBACCO20CIGARETTEPER DAYBEFORE2012-04-30ONGOING2012-04-30YY1VISIT 1

2012-04-30

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Dataset wrap
Namerelrec
Dataset2

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1

1001

RS


RSLNKID


ONE

A

2

1001

LB


LBLNKID


MANY

A

3

1001

RS


RSLNKID


ONE

B

4

1001

VS


VSLNKID


ONE

B

5

1001

RS


RSLNKID


ONE

C

6

1001

SU


SULNKID


ONE

C

7

1001

RS


RSLNKID


ONE

D

8

1001

MH


MHLNKID


MANY

D

9

1001

RS


RSLNKID


ONE

E

10

1001

APMH


MHLNKID


MANY

E

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, RSSTRESN, and RSORRESU) should be populated.

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