The BE example below showshows 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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| Rowcaps |
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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. BESPDEVID holds the identifier for the container into which the plasma is placed. (Not shown: any preservatives with which the container comes pretreated, which would be stored in the Device Properties (DO) domain.) |
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Row 3: | Shows the transportation of the plasma from the site to the lab. |
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Row 4: | Shows the extraction of the RNA, which includes purification and quality control testing to make sure the sample is of a high enough quality to be viable. BESPDEVID holds the identifier for the purification kit. |
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Rows 5-7: | Show the aliquoting of the RNA. | Row 8: | Shows the sequencing of the first RNA aliquot. (Not shown: results from sequencing, which would be stored in the Pharmacogenomics Findings (PF) domain.) |
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Rows 9-10: | Show the freezing of the second and third RNA aliquots. |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | BESEQ | BEREFID | BETERM | BEDECOD | BEPARTY | BEPRTYID | BECAT | VISITNUM | BEDTC | BESTDTC | BEENDTC |
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1 | 3441271ABC | BE | MUABC-01-298203 | 1 | 298B1 | Collecting | COLLECTING | SITE | 05 | COLLECTION | 2 | 2010-04-01T11:50 | 2010-04-01T11:50 |
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2 | 3441271 | BE | MU-298 | 293USHE8 | 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 | 298B1-4298B1-1 | Extracting | EXTRACTING | SITE | 05 | EXTRACTION | 2 | 2010-04-01T11:50 | 2010-04-01T12:10 |
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...
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| Rows 1-25: | Give the specimen types for the first 2 5 specimens as blood and plasma, respectively. These values come from the SPECTYPE codelist. |
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| Dataset2 |
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| Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
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| 1 | 3441271ABC | BE | MUABC-01-298203 | BEREFID | 298B1 | BESPEC | Specimen Type | BLOOD | CRF |
| | 2 | 3441271ABC | BE | MUABC-01-298203 | 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 |
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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 | SPDEVIDISREFID | 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 | ABC001 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 | ABC001 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 | ABC001 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 | ABC001 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 ABC001 |
| 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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