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Dataset wrap |
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Rowcaps |
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Rows 1-2: | Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study. | Row 8: | Shows that the sponsor's study reference ID is not applicable. | Rows 9-12: | Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The Study Director is associated with the Test Facility. |
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Dataset2 |
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Row | STUDYID | GNTXAID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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1 | 123 | NRU | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
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2 | 123 | NRU | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
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3 | 123 | NRU | TS | 1 |
| STSTDTC | Study Start Date | 2022-05-25 |
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4 | 123 | NRU | TS | 1 |
| STITLE | Study Title | Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay |
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5 | 123 | NRU | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
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6 | 123 | NRU | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
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7 | 123 | NRU | TS | 1 |
| SSPONSOR | Sponsor Organization | Example Sponsor Inc. |
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8 | 123 | NRU | TS | 1 |
| SPREFID | Sponsor Study Reference ID |
| NOT APPLICABLE |
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9 | 123 | NRU | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Test Lab Name |
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10 | 123 | NRU | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
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11 | 123 | NRU | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
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12 | 123 | NRU | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
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13 | 123 | NRU | TS | 1 |
| GLPFL | GLP Flag | Y |
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14 | 123 | NRU | TS | 1 |
| ASTD | Assay Standard | OECD GUIDELINE FOR THE TESTING OF CHEMICALS No. 487 |
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15 | 123 | NRU | TS | 1 |
| ASTDV | Assay Standard Version | 29-July-2016 |
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16 | 123 | NRU | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
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17 | 123 | NRU | TS | 1 |
| SSSTYP | Study Sub Type | MICRONUCLEUS TEST |
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18 | 123 | NRU | TS | 1 |
| SPECIES | Species | HUMAN |
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19 | 123 | NRU | TS | 1 |
| TESTSYSCELLLN | Test SystemCell Line | |
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This example trial set dataset, tx.xpt, shows information about the test conditions for set A1 and A2 in this example study, 123. Set A1 and A2 can be seen in the first and second rows respectively of Table 1 in the Sample Report table for Study 123 (above). For brevity, the trial sets dataset, tx.xpt, and the findings dataset, gt.xpt do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets.
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