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.
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Row 1: | Shows the collection of the blood sample. |
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Row Rows 2-5: | Shows 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.) |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | BESEQ | BEREFID | BETERM | BEDECOD | BEPARTY | BEPRTYID | BECAT | VISITNUM | BEDTC | BESTDTC | BEENDTC |
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1 | ABC | BE | ABC-01-203 | 1 | 298B1 | Collecting | COLLECTING | SITE | 05 | COLLECTION | 2 | 2010-04-01T11:50 | 2010-04-01T11:50 |
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2 | ABC | BE | ABC-01-203 | 2 | 298B1-1 | Extracting | EXTRACTING | SITE | 05 | EXTRACTION | 2 | 2010-04-01T11:50 | 2010-04-01T12:10 |
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3 | ABC | BE | ABC-01-203 | 3 | 298B1-2 | Extracting | EXTRACTING | SITE | 05 | EXTRACTION | 2 | 2010-04-01T11:50 | 2010-04-01T12:10 |
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4 | ABC | BE | ABC-01-203 | 4 | 298B1-3 | Extracting | EXTRACTING | SITE | 05 | EXTRACTION | 2 | 2010-04-01T11:50 | 2010-04-01T12:10 |
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5 | ABC | BE | ABC-01-203 | 5 | 298B1-4 | Extracting | EXTRACTING | SITE | 05 | EXTRACTION | 2 | 2010-04-01T11:50 | 2010-04-01T12:10 |
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...
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.
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| 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. |
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| Dataset2 |
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| hi1style | yellow |
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| hi1 | column ISBDAGNT |
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| tableid | IS table 1 |
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| Row | STUDYID | DOMAIN | USUBJID | ISREFID | ISSEQ | ISGRPID | ISLNKID | ISTESTCD | ISTEST | ISTSTCND | ISCNDAGT | ISTSTDTL | ISORRES | ISORRESU | ISSTRESC | ISSTRESN | ISSTRESU | ISSPEC | ISMETHOD | ISDTC |
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1 | ABC | IS | ABC-01-203 | 298B1-1 | 1 | 1 | B | IFNG | Interferon Gamma | WITHOUT STIMULATING AGENT |
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| 0.9 | IU/mL | 0.9 | 0.9 | IU/mL | PLASMA | ELISA | 2013-08-26 | 2 | ABC | IS | ABC-01-203 | 298B1-12 | 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 | 298B1-23 | 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 | 298B1-34 | 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 | 298B1-4 |
| 4 | 1 | B | IFNG | Interferon Gamma |
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| INTERPRETATION | POSITIVE |
| POSITIVE |
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| ELISA | 2013-08-26 |
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The relationship between BE and IS is modeled using the RELREC dataset:
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| title | relrec.xpt |
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| Name | relrec |
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| Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | 3441271 | BE |
| BEREFID |
| ONE | 1 |
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2 | 3441271 | IS |
| ISREFID |
| ONE | 1 |
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