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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

The RELREC table below shows how to define the one-to-one relationship (as defined in RELTYPE), or the one-to-many relationship between the RS domain and the LB, VS, SU, and the MH domains for the ASSIGN Risk Score.

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

Dataset wrap
Namerelrec
STUDYX
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALRELTYPERELID
1

RS


RSLNKID


ONE

1

D

2

8

STUDYX

1001

VS

MH

VSLNKID


MHLNKID

ONE


MANY

1

D

3

9

STUDYX

1001

RS


RSLNKID


ONE

2

E

4

10

STUDYX

1001

LB

APMH

LBLNKID


MHLNKID

ONE


MANY

2

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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