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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-367 |
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| Rows 1-2: | Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, | 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-366 |
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since both GLP types apply for this study. | | Row 8: | Shows that the applicant'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. | | 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). | Jira |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-56 |
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| | Shows that this study includes a Bacterial Reverse Mutation assessment. | | Rows 19-23: | Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with 4 different strains and the cell line that are tested in this study. | | Rows 25-27: | 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 | GNTXAID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF |
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| 1 | 8325064Ames | TS | 1 |
| GLPTYP | Good Laboratory Practice Type | FDA |
| | 2 | 8325064Ames | TS | 2 |
| GLPTYP | Good Laboratory Practice Type | OECD |
| | 3 | 8325064Ames | TS | 1 |
| STSTDTC | Study Start Date | 2015-07-29 |
| | 4 | 8325064Ames | TS | 1 |
| STITLE | Study Title | The Bacterial Reverse Mutation Test, Study 8325064-1 |
| | 5 | 8325064Ames | TS | 1 |
| SNDIGVER | SEND Implementation Guide Version | TOBACCO IMPLEMENTATION GUIDE VERSION 1.0 |
| | 6 | 8325064Ames | TS | 1 |
| SNDCTVER | SEND Controlled Terminology Version | SEND Terminology 2021-09-30 |
| | 7 | 8325064Ames | TS | 1 |
| APPLCNT | Applicant Organization | Example Applicant Inc. |
| | 8 | 8325064Ames | TS | 1 |
| APREFID | Applicant's Study Reference ID |
| NOT APPLICABLE | | 9 | 8325064Ames | TS | 1 | 1 | TSTFNAM | Test Facility Name | Example Tox Lab Name |
| | 10 | 8325064Ames | TS | 1 | 1 | TSTFLOC | Test Facility Location | 10 Somewhere Street, Montgomery, AL 10000 |
| | 11 | 8325064 | Ames | TS | 1 | 1 | TFCNTRY | Test Facility Country | USA |
| | 12 | 8325064 | Ames | TS | 1 | 1 | STDIR | Study Director | Dr. R. Smith |
| | 13 | 8325064Ames | TS | 1 |
| GLPFL | GLP Flag | N |
| | 14 | 8325064Ames | TS | 1 | 4 | TSTGDNAM | Testing Guideline Name | Test NO. 471 |
| | 15 | 8325064Ames | TS | 1 | 4 | TSTGDORG | Testing Guideline Organization | OECD |
| | 16 | 8325064Ames | TS | 1 | 4 | TSTGDVER | Testing Guideline Version | 2020-06-29 |
| | 17 | 8325064 | Ames | TS | 1 |
| SSTYP | Study Type | GENOTOXICITY IN VITRO |
| | 18 | 8325064 | Ames | TS | 1 |
| | Genetic Toxicology Assay Identifier | |
| | 19 | 8325064Ames | TS | 1 | 2 | SPECIES | 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-484 |
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| Species | SALMONELLA TYPHIMURIUM | 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-123 |
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| | 20 | 8325064 | Ames | TS | 1 | 2 | STRAIN | Strain/Substrain | TA98 |
| | 21 | 8325064 | Ames | TS | 2 | 2 | STRAIN | Strain/Substrain | TA100 |
| | 22 | 8325064 | Ames | TS | 3 | 2 | STRAIN | Strain/Substrain | TA1535 |
| | 23 | 8325064Ames | TS | 4 | 2 | STRAIN | Strain/Substrain | TA1537 |
| | 24 | 8325064Ames | TS | 1 | 2 | CELLLN | Cell Line |
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| | 25 | 8325064Ames | TS | 1 | 3 | SPECIES | Species | ESCHERICHIA COLI | 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-482 |
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| | 26 | 8325064Ames | TS | 5 | 3 | STRAIN | Strain/Substrain | WP2 uvrA pKM101 |
| | 27 | 8325064Ames | TS | 2 | 3 | CELLLN | Cell Line |
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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=STM. This REFID refers to the trial set with a SETCD of "SetSTM" | 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-489 |
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, as defined in the TX dataset. LEVEL=1 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set. | | Rows 1, 2, 8, 12, 16: | Show that the trial set SetSTM is the parent of set codes SetA, SetF, SetG, and SetR. | | Row 2: | 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=2 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. | | Rows 3-7: | Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A. | | Row 8: | 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=2 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 9-11: | Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F. | | Row 12: | 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=2 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 13-15: | Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G. | | Row 16: | 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=2 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 17-19: | Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R. | 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-668 |
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| Dataset2 |
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| OLD TABLE (prior to flattening Parent/Child in TX dataset) When this table is removed, remove SetSTM from TX. Row | STUDYID | SETCD | REFID | PARENT | LEVEL | LVLDESC |
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1 | 8325064 | SetSTM | STM |
| 1 | TRIAL SET |
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2 | 8325064 | SetA | A | STM | 2 | EXPERIMENTAL UNIT/TRIAL SET |
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3 | 8325064 | SetA | 1_1 | A | 3 | OBSERVATIONAL UNIT |
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4 | 8325064 | SetA | 1_2 | A | 3 | OBSERVATIONAL UNIT |
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5 | 8325064 | SetA | 1_3 | A | 3 | OBSERVATIONAL UNIT |
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6 | 8325064 | SetA | 1_4 | A | 3 | OBSERVATIONAL UNIT |
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7 | 8325064 | SetA | 1_5 | A | 3 | OBSERVATIONAL UNIT |
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8 | 8325064 | SetF | F | STM | 2 | EXPERIMENTAL UNIT/TRIAL SET |
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9 | 8325064 | SetF | 6_1 | F | 3 | OBSERVATIONAL UNIT |
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10 | 8325064 | SetF | 6_2 | F | 3 | OBSERVATIONAL UNIT |
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11 | 8325064 | SetF | 6_3 | F | 3 | OBSERVATIONAL UNIT |
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12 | 8325064 | SetG | G | STM | 2 | EXPERIMENTAL UNIT/TRIAL SET |
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13 | 8325064 | SetG | 7_1 | G | 3 | OBSERVATIONAL UNIT |
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| 14 | 8325064 | SetG | 7_2 | G | 3 | OBSERVATIONAL UNIT | | 15 | 8325064 | SetG | 7_3 | G | 3 | OBSERVATIONAL UNIT | | 16 | 8325064 | SetG | R | STM | 2 | EXPERIMENTAL UNIT/TRIAL SET | | 17 | 8325064 | SetR | 18_1 | R | 3 | OBSERVATIONAL UNIT | | 18 | 8325064 | SetR | 18_2 | R | 3 | OBSERVATIONAL UNIT | | 19 | 8325064 | SetR | 18_3 | R | 3 | OBSERVATIONAL UNIT |
NEW (remain AFTER we flatten TX dataset) GNTXAID | SETCD | REFID | PARENT | LEVEL | LVLDESC |
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1 | 8325064 |
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Ames | SetA | A |
| 1 | EXPERIMENTAL UNIT/TRIAL SET | 2 | 8325064 |
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Ames | SetA | 1_1 | A | 2 | OBSERVATIONAL UNIT | 3 | 8325064 |
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Ames | SetA | 1_2 | A | 2 | OBSERVATIONAL UNIT | 4 | 8325064 |
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Ames | SetA | 1_3 | A | 2 | OBSERVATIONAL UNIT | 5 | 8325064 |
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Ames | SetA | 1_4 | A | 2 | OBSERVATIONAL UNIT | 6 | 8325064 |
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Ames | SetA | 1_5 | A | 2 | OBSERVATIONAL UNIT | 7 | 8325064 |
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Ames | SetF | F |
| 1 | EXPERIMENTAL UNIT/TRIAL SET | 8 | 8325064 |
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Ames | SetF | 6_1 | F | 2 | OBSERVATIONAL UNIT | 9 | 8325064 |
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Ames | SetF | 6_2 | F | 2 | OBSERVATIONAL UNIT | 10 | 8325064 |
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Ames | SetF | 6_3 | F | 2 | OBSERVATIONAL UNIT | 11 | 8325064 |
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Ames | SetG | G |
| 1 | EXPERIMENTAL UNIT/TRIAL SET | 12 | 8325064 |
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Ames | SetG | 7_1 | G | 2 | OBSERVATIONAL UNIT | 13 | 8325064 |
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Ames | SetG | 7_2 | G | 2 | OBSERVATIONAL UNIT | | 14 | 8325064 |
Ames | SetG | 7_3 | G | 2 | OBSERVATIONAL UNIT | | 15 | 8325064 |
Ames | SetG | R |
| 1 | EXPERIMENTAL UNIT/TRIAL SET | | 16 | 8325064 |
Ames | | SetR | 18_1 | R | 2 | OBSERVATIONAL UNIT | | 17 | 8325064 |
Ames | | SetR | 18_2 | R | 2 | OBSERVATIONAL UNIT | | 18 | 8325064 |
Ames | SetR | 18_3 | R | 2 | OBSERVATIONAL UNIT |
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| 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-454 |
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