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The BE example shows that whole blood was collected from the subject, and treated with TB antigens and other assay agents. Plasma was then extracted from the the blood sample.

Row 1:Shows the collection of the blood sample.
Row 2:Shows the extraction of the plasma via centrifuge. (Not shown: any preservatives with which the container comes pretreated, which would be stored in the Device Properties (DO) domain.)

be.xpt

be.xpt

Row

STUDYID

DOMAIN

USUBJID

BESEQ

BEREFID

BETERM

BEDECOD

BEPARTY

BEPRTYID

BECAT

VISITNUM

BEDTC

BESTDTC

BEENDTC

1

ABC

BE

ABC-01-203

1

298B1

Collecting

COLLECTING

SITE

05

COLLECTION

2

2010-04-01T11:50

2010-04-01T11:50


2

ABC

BE

ABC-01-203

2

298B1-1

Extracting

EXTRACTING

SITE

05

EXTRACTION

2

2010-04-01T11:50

2010-04-01T12:10


3

ABC

BE

ABC-01-203

3

298B1-2

Extracting

EXTRACTING

SITE

05

EXTRACTION

2

2010-04-01T11:50

2010-04-01T12:10


4

ABC

BE

ABC-01-203

4

298B1-3

Extracting

EXTRACTING

SITE

05

EXTRACTION

2

2010-04-01T11:50

2010-04-01T12:10


5

ABC

BE

ABC-01-203

5

298B1-4

Extracting

EXTRACTING

SITE

05

EXTRACTION

2

2010-04-01T11:50

2010-04-01T12:10


$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The specimen type is given in a supplemental qualifier that mimics the standard findings variable --SPEC, and draws from the 2 codelists (GENSMP and SPECTYPE) for its values, depending on whether or not the biospecimen is a sample of the subject's genetic material.

Rows 1-5:Give the specimen types for the 5 specimens as blood and plasma, respectively. These values come from the SPECTYPE codelist.

Row Captions Debug Message

There seems to be only one row caption. Please rephrase as narrative.

$titleHtml

suppbe.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1ABCBEABC-01-203BEREFID298B1BESPECSpecimen TypeBLOODCRF
2ABCBEABC-01-203BEREFID298B1-1BESPECSpecimen TypePLASMACRF
3ABCBEABC-01-203BEREFID

298B1-2

BESPECSpecimen TypePLASMACRF
4ABCBEABC-01-203BEREFID

298B1-3

BESPECSpecimen TypePLASMACRF
5ABCBEABC-01-203BEREFID

298B1-4

BESPECSpecimen TypePLASMACRF
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The IS example shows the measured changes in the interferon gamma levels in the subject's plasma sample. Note REFID is used to link the BE and IS datasets.

is.xpt

xx.xpt

Row

STUDYID

DOMAIN

USUBJID

ISREFID

ISSEQ

ISGRPID

ISLNKID

ISTESTCD

ISTEST

ISTSTCND

ISCNDAGT

ISTSTDTL

ISORRES

ISORRESU

ISSTRESC

ISSTRESN

ISSTRESU

ISSPEC

ISMETHOD

ISDTC

1

ABC

IS

ABC-01-203


1

1

B

IFNG

Interferon Gamma

WITHOUT STIMULATING AGENT

0.9

IU/mL

0.90.9

IU/mL

PLASMA

ELISA

2013-08-26

2

ABC

IS

ABC-01-203

298B1-1

2

1

B

IFNG

Interferon Gamma

WITH STIMULATING AGENT

TB1 Antigen


6.2

IU/mL

6.26.2

IU/mL

PLASMA

ELISA

2013-08-26

3

ABC

IS

ABC-01-203

298B1-2

2

1

B

IFNG

Interferon Gamma

WITH STIMULATING AGENT

TB2 Antigen


9.8

IU/mL

9.89.8

IU/mL

PLASMA

ELISA

2013-08-26
4ABCIS

ABC-01-203

298B1-3

3

1

B

IFNG

Interferon Gamma

WITH STIMULATING AGENT

Mitogen


5

IU/mL

55

IU/mL

PLASMA

ELISA

2013-08-26
5ABCIS

ABC-01-203

298B1-4

4

1

B

IFNG

Interferon Gamma



INTERPRETATION

POSITIVE


POSITIVE




ELISA

2013-08-26
$warningHtml
The relationship between BE and IS is modeled using the RELREC dataset:
$titleHtml

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1

3441271

BE


BEREFID


ONE

1

2

3441271

IS


ISREFID


ONE

1

$warningHtml

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