This leThis example shows a sample report table, trial design, and results dataset for study 123 for the determination of the in vitro genotoxicity potential of tobacco products using the in vitro micronucleus assay. 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-642 |
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Rows 1-17: | Show the experimental parameters that are common for table 1 of study 123. | Rows 18, 25: | Show that sets A1 and A2 each have a parent set code of A. As a child of set A, each of these sets inherit the test conditions of set A. | Rows 18-24: | Show trial set parameters and values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short-term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0". Set A1 is associated with the first row in the sample report table for study 123. | Rows 25-31: | Show trial set parameters and values that comprise the test conditions for trial set A2. Set A2 is the data for the short-term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250". Set A2 is associated with the second row in the sample report table for study 123. |
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Dataset2 |
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Row | STUDYID | GNTXAID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 123 | MNvit | TX | A | ST+S9 | | METACTIND | Metabolic Activating Agent Name | +S9 | 2 | 123 | MNvit | TX | A | ST+S9 | 2 | METACTFL | Presence of Metabolic Activation Flag | Y | 3 | 123 | MNvit | TX | A | ST+S9 | 3 | IVTDMIN | In vitro Treatment Duration Minimum | 3 | 4 | 123 | MNvit | TX | A | ST+S9 | 4 | IVTDTRG | In vitro Treatment Duration Target | 3.5 | 5 | 123 | MNvit | TX | A | ST+S9 | 5 | IVTDMAX | In vitro Treatment Duration Maximum | 4 | 6 | 123 | MNvit | TX | A | ST+S9 | 6 | IVTDU | In vitro Treatment Duration Unit | HOURS | 7 | 123 | MNvit | TX | A | ST+S9 | 7 | RCVDMIN | Recovery Duration Minimum | 23.5 | 8 | 123 | MNvit | TX | A | ST+S9 | 8 | RCVDTRG | Recovery Duration Target | 24 | 9 | 123 | MNvit | TX | A | ST+S9 | 9 | RCVDMAX | Recovery Duration Maximum | 24.5 | 10 | 123 | MNvit | TX | A | ST+S9 | 10 | RCVDU | Recovery Duration Unit | HOURS | 11 | 123 | MNvit | TX | A | ST+S9 | 11 | INCBTMP | Incubation Temperature | 37 | 12 | 123 | MNvit | TX | A | ST+S9 | 12 | INCBTMPU | Incubation Temperature Unit | C | 13 | 123 | MNvit | TX | A | ST+S9 | 13 | ATMRHP | Atmospheric Relative Humidity Percent | 50 | 14 | 123 | MNvit | TX | A | ST+S9 | 14 | ATMCO2P | Atmospheric CO2 Percent | 5 | 15 | 123 | MNvit | TX | A | ST+S9 | 15 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | 16 | 123 | MNvit | TX | A | ST+S9 | 16 | EXPTYP | | Submerged | 17 | 123 | MNvit | TX | A | ST+S9 | 17 | SAMTYP | Sample Type | Total Particulate Matter in DMSO | 18 | 123 | MNvit | TX | A1 | ST+S9_C0 | | PSETCD | Parent Set Code | A | 19 | 123 | MNvit | TX | A1 | ST+S9_CO | 2 | ITVNAM | Intervention Article Name | Tobacco ProdA | 20 | 123 | MNvit | TX | A1 | ST+S9_C0 | 3 | ITVTYPE | Intervention Article Type | Negative Control | 21 | 123 | MNvit | TX | A1 | ST+S9_C0 | 4 | ITVCONC | Intervention Article Concentration | 0 | 22 | 123 | MNvit | TX | A1 | ST+S9_C0 | 5 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 23 | 123 | MNvit | TX | A1 | ST+S9_C0 | 6 | SPDEVID | Applicant-defined device identifier | PUFFMASTER3K | 24 | 123 | MNvit | TX | A1 | ST+S9_C0 | 7 | SMKRGM | Smoke Smoking Regimen | Medium Intensity RegimenMEDIUM INTENSITY REGIMEN | 25 | 123 | MNvit | TX | A2 | ST+S9_C1250 | | PSETCD | Parent Set Code | A | 26 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 2 | ITVNAM | Intervention Article Name | Tobacco ProdA | 27 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 3 | ITVTYPE | Intervention Article Type | Product | 28 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 4 | ITVCONC | Intervention Article Concentration | 1250 | 29 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 5 | ITVCONCU | Intervention Article Concentration Unit | ug/ml | 30 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 6 | SPDEVID | Applicant-defined Device Identifier | PUFFMASTER2023 | 31 | 123 | MNvit | TX | A2 | ST+S9_C1250 | 7 | SMKRGM | Smoke Smoking Regimen | High Intensity RegimenHIGH INTENSITY REGIMEN |
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Row 1: | Shows the value of REFID=C0. This REFID refers to the trial set with a SETCD of "A1", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set. | Rows 2-5: | Show the values of 4 observational units (C0_Count1 through C0_Count4) that are within the parent experimental unit, REFID=C0. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset. | Row 6: | Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of "A2", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set. | Rows 7-10: | Show the values of 4 observational units (C1250_Count1 through C1250_Count4) 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-687 |
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that are within the parent experimental unit, REFID=C1250. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset. |
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Dataset2 |
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| Row | STUDYID | GNTXAID | SETCD | REFID | PARENT | LEVEL | LVLDESC |
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1 | 123 | MNvit | | C0 |
| 1 | EXPERIMENTAL UNIT/TRIAL SET | 2 | 123 | MNvit | A1 | C0-Count1 | C0 | 2 | OBSERVATIONAL UNIT | 3 | 123 | MNvit | A1 | C0-Count2 | C0 | 2 | OBSERVATIONAL UNIT | 4 | 123 | MNvit | A1 | C0-Count3 | C0 | 2 | OBSERVATIONAL UNIT | 5 | 123 | MNvit | A1 | C0-Count4 | C0 | 2 | OBSERVATIONAL UNIT | 6 | 123 | MNvit | A2 | C1250 |
| 1 | EXPERIMENTAL UNIT/TRIAL SET | 7 | 123 | MNvit | A2 | C1250-Count1 | C1250 | 2 | OBSERVATIONAL UNIT | 8 | 123 | MNvit | A2 | C1250-Count2 | C1250 | 2 | OBSERVATIONAL UNIT | 9 | 123 | MNvit | A2 | C1250-Count3 | C1250 | 2 | OBSERVATIONAL UNIT | 10 | 123 | MNvit | A2 | C1250-Count4 | C1250 | 2 | OBSERVATIONAL UNIT |
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