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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. |
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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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This example Trial Set (TX) dataset shows information about the test conditions for SetA and SetR in this study. For brevity, the dataset does not show information for SetF, SetG, or any other sets.
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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-483 |
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A fully formed TX dataset for this example study would include information about the test conditions for all sets.
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| Row 1: | Shows the value of REFID=A. This REFID refers to the trial set with a SETCD of "SetA", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, DMSO.| 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-458 | | Rows 2-6: | Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A. | | Row 7: | Shows the value of REFID=F. This REFID refers to the trial set with a SETCD of "SetF", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1. | | Rows 8-10: | Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F. | | Row 11: | Shows the value of REFID=G. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1. | | Rows 12-14: | Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G. | | Row 15: | Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, NaN3. | | Rows 16-18: | Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R. |
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| Dataset2 |
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| Row | STUDYID | SETCD | REFID | PARENT | LEVEL | LVLDESC |
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1 | 8325064 | SetA | A |
| 1 | EXPERIMENTAL UNIT/TRIAL SET |
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2 | 8325064 | SetA | 1_1 | A | 2 | OBSERVATIONAL UNIT |
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3 | 8325064 | SetA | 1_2 | A | 2 | OBSERVATIONAL UNIT |
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4 | 8325064 | SetA | 1_3 | A | 2 | OBSERVATIONAL UNIT |
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5 | 8325064 | SetA | 1_4 | A | 2 | OBSERVATIONAL UNIT |
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6 | 8325064 | SetA | 1_5 | A | 2 | OBSERVATIONAL UNIT |
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7 | 8325064 | SetF | F |
| 1 | EXPERIMENTAL UNIT/TRIAL SET |
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8 | 8325064 | SetF | 6_1 | F | 2 | OBSERVATIONAL UNIT |
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9 | 8325064 | SetF | 6_2 | F | 2 | OBSERVATIONAL UNIT |
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10 | 8325064 | SetF | 6_3 | F | 2 | OBSERVATIONAL UNIT |
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11 | 8325064 | SetG | G |
| 1 | EXPERIMENTAL UNIT/TRIAL SET |
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12 | 8325064 | SetG | 7_1 | G | 2 | OBSERVATIONAL UNIT |
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13 | 8325064 | SetG | 7_2 | G | 2 | OBSERVATIONAL UNIT |
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| 14 | 8325064 | SetG | 7_3 | G | 2 | OBSERVATIONAL UNIT | | 15 | 8325064 | SetR | R |
| 1 | EXPERIMENTAL UNIT/TRIAL SET | | 16 | 8325064 | SetR | 18_1 | R | 2 | OBSERVATIONAL UNIT | | 17 | 8325064 | SetR | 18_2 | R | 2 | OBSERVATIONAL UNIT | | 18 | 8325064 | SetR | 18_3 | R | 2 | OBSERVATIONAL UNIT |
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