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This example Trial Summary (TS) dataset, shows many informational fields that provide context at the study level.
Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-664 |
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Dataset wrap |
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Rowcaps |
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Rows 1-2: | Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this study. | Row 3: | Shows that this study was conducted as a GLP study. | Rows 4-5: | Show the study start date and study title. | Rows 6-7: | Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study. | Row 8: | Shows the applicant's organization. | Row 9: | Shows that the applicant's study reference ID is not applicable. | Rows 10-13: | 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. | Rows 14-16: | Show that TSGRPID (TSGRPID=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER). | | Shows the study type for this study. | | Shows that this study includes a Bacterial Reverse Mutation Assay. | Rows 19-27: | Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with the 4 different strains and cell lines that are tested in this study. | Rows 28-30: | Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain and cell line that is tested in this study. Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-665 |
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Dataset2 |
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Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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1 | 8325064 | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
| 2 | 8325064 | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
| 3 | 8325064 | TS | 1 |
| GLPFL | GLP Flag | N |
| 4 | 8325064 | TS | 1 |
| STSTDTC | Study Start Date | 2015-07-29 |
| 5 | 8325064 | TS | 1 |
| STITLE | Study Title | The Bacterial Reverse Mutation Test, Study 8325064-1 |
| 6 | 8325064 | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
| 7 | 8325064 | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
| 8 | 8325064 | TS | 1 |
| APPLCNT | Applicant Organization | Example Applicant Inc. |
| 9 | 8325064 | TS | 1 |
| APREFID | Applicant's Study Reference ID |
| NOT APPLICABLE | 10 | 8325064 | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
| 11 | 8325064 | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
| 12 | 8325064 | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
| 13 | 8325064 | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
| 14 | 8325064 | TS | 1 | 4 | TSTGDNAM | Testing Guideline Name | Test NO. 471 |
| 15 | 8325064 | TS | 1 | 4 | TSTGDORG | Testing Guideline Organization | OECD |
| 16 | 8325064 | TS | 1 | 4 | TSTGDVER | Testing Guideline Version | 2020-06-29 |
| 17 | 8325064 | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
| 18 | 8325064 | TS | 1 |
| | Genetic Toxicology Assay Identifier | |
| 19 | 8325064 | TS | 1 | 2 | | Species | |
| 20 | 8325064 | TS | 1 | 2 | STRAIN | Strain/Substrain | TA98 |
| 21 | 8325064 | TS | 2 | 2 | STRAIN | Strain/Substrain | TA100 |
| 22 | 8325064 | TS | 3 | 2 | STRAIN | Strain/Substrain | TA1535 |
| 23 | 8325064 | TS | 4 | 2 | STRAIN | Strain/Substrain | TA1537 |
| 24 | 8325064 | TS | 1 | 2 | CELLLN | Cell Line | TA 98 hisD3052; rfa-; uvrB- |
| 25 | 8325064 | TS | 2 | 2 | CELLLN | Cell Line | TA 100 hisG46; rfa-; uvrB- |
| 26 | 8325064 | TS | 3 | 2 | CELLLN | Cell Line | TA 1535 hisG46; rfa-; uvrB- |
| 27 | 8325064 | TS | 4 | 2 | CELLLN | Cell Line | TA 1537 hisC3076; rfa-; uvrB- |
| 28 | 8325064 | TS | 2 | 3 | SPECIES | Species | |
| 29 | 8325064 | TS | 5 | 3 | STRAIN | Strain/Substrain | WP2 uvrA pKM101 |
| 30 | 8325064 | TS | 5 | 3 | CELLLN | Cell Line | trpE uvrA |
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