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 whole blood sample.
Row 1:
Shows the collection of the blood sample.
Rows 2-5:
Show 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
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
QNAM
QLABEL
QVAL
QORIG
QEVAL
1
ABC
BE
ABC-01-203
BEREFID
298B1
BESPEC
Specimen Type
BLOOD
CRF
2
ABC
BE
ABC-01-203
BEREFID
298B1-1
BESPEC
Specimen Type
PLASMA
CRF
3
ABC
BE
ABC-01-203
BEREFID
298B1-2
BESPEC
Specimen Type
PLASMA
CRF
4
ABC
BE
ABC-01-203
BEREFID
298B1-3
BESPEC
Specimen Type
PLASMA
CRF
5
ABC
BE
ABC-01-203
BEREFID
298B1-4
BESPEC
Specimen Type
PLASMA
CRF
$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.
Row 1:
Shows the measurement of interferon gamma in the plasma sample that is treated with nothing (i.e., TB Ag-Nil.)
Rows 2-3:
Show the measurement of interferon gamma in the plasma samples that are treated with TB1 Antigen and TB2 Antigen.
Row 4:
Shows the measurement of interferon gamma in the plasma sample that is treated with the negative control, Mitogen.
Row 5:
Shows the interpretation of the interferon gamma assessment.
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
298B1-1
1
1
B
IFNG
Interferon Gamma
WITHOUT STIMULATING AGENT
0.9
IU/mL
0.9
0.9
IU/mL
PLASMA
ELISA
2013-08-26
2
ABC
IS
ABC-01-203
298B1-2
2
1
B
IFNG
Interferon Gamma
WITH STIMULATING AGENT
TB1 Antigen
6.2
IU/mL
6.2
6.2
IU/mL
PLASMA
ELISA
2013-08-26
3
ABC
IS
ABC-01-203
298B1-3
2
1
B
IFNG
Interferon Gamma
WITH STIMULATING AGENT
TB2 Antigen
9.8
IU/mL
9.8
9.8
IU/mL
PLASMA
ELISA
2013-08-26
4
ABC
IS
ABC-01-203
298B1-4
3
1
B
IFNG
Interferon Gamma
WITH STIMULATING AGENT
Mitogen
5
IU/mL
5
5
IU/mL
PLASMA
ELISA
2013-08-26
5
ABC
IS
ABC-01-203
4
1
B
IFNG
Interferon Gamma
INTERPRETATION
POSITIVE
POSITIVE
ELISA
2013-08-26
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The relationship between BE and IS is modeled using the RELREC dataset: