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| Rows 1-14: | Show trial set SetSTM, with trial set parameters and trial set values that comprise the test conditions for all data for the species S. typhimurium. | | Rows 15, 24, 33, 42: | Show that SetA, SetF, SetG, and SetR each have a parent set code of SetSTM. As a child set of SetSTM, each of these sets inherit the test conditions of SetSTM. | | Rows 15-23: | Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the data for the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064. | 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-666 |
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| | Rows 24-32: | Show trial set parameters and trial set values that comprise the test conditions for the set SetF. SetF is the data for the strain of TA98 with a concentration value of 500 µg/plate. SetF is associated with the sixth row, labeled "SetF", in the report table for example study 8325064. | 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-667 |
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| | Rows 33-41: | Show trial set parameters and trial set values that comprise the test conditions for the set SetG. SetG is the data for the strain of TA98 with a concentration value of 1600 µg/plate. SetG is associated with the seventh row, labeled "SetG", in the report table for example study 8325064. | | Rows 42-50: | Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the strain of TA100, positive control with a concentration value of 2 µg/plate. SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064. | | Row 10: | SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID, in this case CIG01a, matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2, Product Design Parameters and Conformance Testing, Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a. The TO domain is described in Section 2.8.8.1, Tobacco Product Identifiers and Descriptors (TO). | | Row 13: | SPDEVID is the applicant-defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset (see also Section 2.8.9.7, SEND Device Identifiers (DI)). The value of SPDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1. | | Row 14: | Shows a value for SMKRGM. SMKRGM serves as a link to the Device-In Use Properties (DU) domain (see also Section 2.8.9.8, SEND Device-In-Use (DU)), where a matching value of SMKRGM indicates parameters of the smoking regimen performed by the smoking machine, as in the DU dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 2. |
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| Dataset2 |
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THIS (RED FONT) IS THE OLD DATASET PRIOR TO "flattening":| STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL | | 1 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | | SPECIES | Species | SALMONELLA TYPHIMURIUM | | 2 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 2 | IVTDMIN | In vitro Treatment Duration Minimum | 71.5 | | 3 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 3 | IVTDTRG | In vitro Treatment Duration Target | 72 | | 4 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 4 | IVTDMAX | In vitro Treatment Duration Maximum | 72.5 | | 5 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 5 | IVTDU | In vitro TreatmentRowDuration Unit | HOURS | | 6 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 6 | INCBTMP | Incubation Temperature | 37 | | 7 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 7 | INCBTMPU | Incubation Temperature Unit | C | | 8 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 8 | ATMRHP | Atmospheric Relative Humidity Percent | 50 | | 9 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 9 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 10 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 10 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 11 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 11 | EXPTYP | | Submerged | | 12 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 12 | SAMTYP | Sample Type | Total Particulate Matter in PBS | | 13 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 13 | SPDEVID | Applicant-defined device identifier | PUFFMASTER3K | | 14 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 14 | SMKRGM | Smoking Regimen | NON-INTENSE REGIMEN | | 15 | 8325064 | TX | SetA | A-TA98-C0 | | SPECIES | Species | SALMONELLA TYPHIMURIUM | | 16 | 8325064 | TX | SetA | A-TA98-C0 | 2 | IVTDMIN | In vitro Treatment Duration Minimum | 71.5 | | 17 | 8325064 | TX | SetA | A-TA98-C0 | 3 | IVTDTRG | In vitro Treatment Duration Target | 72 | | 18 | 8325064 | TX | SetA | A-TA98-C0 | 4 | IVTDMAX | In vitro Treatment Duration Maximum | 72.5 | | 19 | 8325064 | TX | SetA | A-TA98-C0 | 5 | IVTDU | In vitro TreatmentRowDuration Unit | HOURS | | 20 | 8325064 | TX | SetA | A-TA98-C0 | 6 | INCBTMP | Incubation Temperature | 37 | | 21 | 8325064 | TX | SetA | A-TA98-C0 | 7 | INCBTMPU | Incubation Temperature Unit | C | | 22 | 8325064 | TX | SetA | A-TA98-C0 | 8 | ATMRHP | Atmospheric Relative Humidity Percent | 50 | | 23 | 8325064 | TX | SetA | A-TA98-C0 | 9 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 24 | 8325064 | TX | SetA | A-TA98-C0 | 10 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 25 | 8325064 | TX | SetA | A-TA98-C0 | 11 | EXPTYP | | Submerged | | 26 | 8325064 | TX | SetA | A-TA98-C0 | 12 | SAMTYP | Sample Type | Total Particulate Matter in PBS | | 27 | 8325064 | TX | SetA | A-TA98-C0 | 13 | SPDEVID | Applicant-defined device identifier | PUFFMASTER3K | | 28 | 8325064 | TX | SetA | A-TA98-C0 | 14 | SMKRGM | Smoking Regimen | NON-INTENSE REGIMEN | | 29 | 8325064 | TX | SetA | A-TA98-C0 | 15 | PSETCD | Parent Set Code | SetSTM | | 30 | 8325064 | TX | SetA | A-TA98-C0 | 15 | STRAIN | Strain/Substrain | TA98 | | 31 | 8325064 | TX | SetA | A-TA98-C0 | 16 | METACTIND | Metabolic Activating Agent Name | NOT APPLICABLE | | 32 | 8325064 | TX | SetA | A-TA98-C0 | 17 | METACTFL | Presence of Metabolic Activation Flag | N | | 33 | 8325064 | TX | SetA | A-TA98-C0 | 18 | ITVNAM | Intervention Article Name | DMSO | | 34 | 8325064 | TX | SetA | A-TA98-C0 | 19 | ITVTYPE | Intervention Article Type | VEHICLE | | 35 | 8325064 | TX | SetA | A-TA98-C0 | 20 | ITVCONC | Intervention Article Concentration | 100 | | 36 | 8325064 | TX | SetA | A-TA98-C0 | 21 | ITVCONCU | Intervention Article Concentration Unit | % | | 37 | 8325064 | TX | SetA | A-TA98-C0 | 22 | TRTV | Treatment Vehicle | DMSO | | 38 | 8325064 | TX | SetF | F-TA98-C500 | 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-485 |
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| 23 | PSETCD | Parent Set Code | SetSTM | | 39 | 8325064 | TX | SetF | F-TA98-C500 | 24 | STRAIN | Strain/Substrain | TA98 | | 40 | 8325064 | TX | SetF | F-TA98-C500 | 25 | METACTIND | Metabolic Activating Agent Name | NOT APPLICABLE | | 41 | 8325064 | TX | SetF | F-TA98-C500 | 26 | METACTFL | Presence of Metabolic Activation Flag | N | | 42 | 8325064 | TX | SetF | F-TA98-C500 | 27 | ITVNAM | Intervention Article Name | TA1 | | 43 | 8325064 | TX | SetF | F-TA98-C500 | 28 | ITVTYPE | Intervention Article Type | PRODUCT | | 44 | 8325064 | TX | SetF | F-TA98-C500 | 29 | ITVCONC | Intervention Article Concentration | 500 | | 45 | 8325064 | TX | SetF | F-TA98-C500 | 30 | ITVCONCU | Intervention Article Concentration Unit | ug/plate | | 46 | 8325064 | TX | SetF | F-TA98-C500 | 31 | TRTV | Treatment Vehicle | DMSO | | 47 | 8325064 | TX | SetG | G-TA98-C1600 | 31 | PSETCD | Parent Set Code | SetSTM | | 48 | 8325064 | TX | SetG | G-TA98-C1600 | 32 | STRAIN | Strain/Substrain | TA98 | | 49 | 8325064 | TX | SetG | G-TA98-C1600 | 33 | METACTIND | Metabolic Activating Agent Name | NOT APPLICABLE | | 50 | 8325064 | TX | SetG | G-TA98-C1600 | 34 | METACTFL | Presence of Metabolic Activation Flag | N | | 51 | 8325064 | TX | SetG | G-TA98-C1600 | 35 | ITVNAM | Intervention Article Name | TA1 | | 52 | 8325064 | TX | SetG | G-TA98-C1600 | 36 | ITVTYPE | Intervention Article Type | Product | | 53 | 8325064 | TX | SetG | G-TA98-C1600 | 37 | ITVCONC | Intervention Article Concentration | 1600 | | 54 | 8325064 | TX | SetG | G-TA98-C1600 | 38 | ITVCONCU | Intervention Article Concentration Unit | ug/plate | | 55 | 8325064 | TX | SetG | G-TA98-C1600 | 39 | TRTV | Treatment Vehicle | DMSO | | 56 | 8325064 | TX | SetR | R-TA100-C2 | 39 | PSETCD | Parent Set Code | SetSTM | | 57 | 8325064 | TX | SetR | R-TA100-C2 | 40 | STRAIN | Strain/Substrain | TA100 | | 58 | 8325064 | TX | SetR | R-TA100-C2 | 41 | METACTIND | Metabolic Activating Agent Name | NOT APPLICABLE | | 59 | 8325064 | TX | SetR | R-TA100-C2 | 42 | METACTFL | Presence of Metabolic Activation Flag | N | | 60 | 8325064 | TX | SetR | R-TA100-C2 | 43 | ITVNAM | Intervention Article Name | NaN3 | | 61 | 8325064 | TX | SetR | R-TA100-C2 | 44 | ITVTYPE | Intervention Article Type | Positive Control | | 62 | 8325064 | TX | SetR | R-TA100-C2 | 45 | ITVCONC | Intervention Article Concentration | 2 | | 63 | 8325064 | TX | SetR | R-TA100-C2 | 46 | ITVCONCU | Intervention Article Concentration Unit | ug/plate | 64 | STUDYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
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| 1 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | | SPECIES | Species | SALMONELLA TYPHIMURIUM | | 2 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 2 | IVTDMIN | In vitro Treatment Duration Minimum | 71.5 | | 3 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 3 | IVTDTRG | In vitro Treatment Duration Target | 72 | | 4 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 4 | IVTDMAX | In vitro Treatment Duration Maximum | 72.5 | | 5 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 5 | IVTDU | In vitro TreatmentRowDuration Treatment Duration Unit | HOURS | | 6 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 6 | INCBTMP | Incubation Temperature | 37 | | 7 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 7 | INCBTMPU | Incubation Temperature Unit | C | | 8 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 8 | ATMRHP | Atmospheric Relative Humidity Percent | 50 | | 9 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 9 | ATMCO2P | Atmospheric CO2 Percent | 5 | | 10 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 10 | SPTOBID | Applicant-defined tobacco identifier | CIG01a | | 11 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 11 | EXPTYP | | Submerged | | 12 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 12 | SAMTYP | Sample Type | Total Particulate Matter in PBS | | 13 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 13 | SPDEVID | Applicant-defined device identifier | PUFFMASTER3K | | 14 | 8325064 | TX | SetSTM | SALMONELLA TYPHIMURIUM | 14 | SMKRGM | Smoking Regimen | NON-INTENSE REGIMEN | | 15 | 8325064 | TX | SetA | A-TA98-C0 | 15 | PSETCD | Parent Set Code | SetSTM | | 16 | 8325064 | TX | SetA | A-TA98-C0 | 15 | STRAIN | Strain/Substrain | TA98 | | 17 | 8325064 | TX | SetA | A-TA98-C0 | 16 | METACTIND | Metabolic Activating Agent Name | NOT APPLICABLE | | 18 | 8325064 | TX | SetA | A-TA98-C0 | 17 | METACTFL | Presence of Metabolic Activation Flag | N | | 19 | 8325064 | TX | SetA | A-TA98-C0 | 18 | ITVNAM | Intervention Article Name | DMSO | | 20 | 8325064 | TX | SetA | A-TA98-C0 | 19 | ITVTYPE | Intervention Article Type | VEHICLE | | 21 | 8325064 | TX | SetA | A-TA98-C0 | 20 | ITVCONC | Intervention Article Concentration | 100 | | 22 | 8325064 | TX | SetA | A-TA98-C0 | 21 | ITVCONCU | Intervention Article Concentration Unit | % | | 23 | 8325064 | TX | SetA | A-TA98-C0 | 22 | TRTV | Treatment Vehicle | DMSO | | 24 | 8325064 | TX | SetF | F-TA98-C500 | 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-485 |
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| 23 | PSETCD | Parent Set Code | SetSTM | | 25 | 8325064 | TX | SetF | F-TA98-C500 | 24 | STRAIN | Strain/Substrain | TA98 | | 26 | 8325064 | TX | SetF | F-TA98-C500 | 25 | METACTIND | Metabolic Activating Agent Name | NOT APPLICABLE | | 27 | 8325064 | TX | SetF | F-TA98-C500 | 26 | METACTFL | Presence of Metabolic Activation Flag | N | | 28 | 8325064 | TX | SetF | F-TA98-C500 | 27 | ITVNAM | Intervention Article Name | TA1 | | 29 | 8325064 | TX | SetF | F-TA98-C500 | 28 | ITVTYPE | Intervention Article Type | PRODUCT | | 30 | 8325064 | TX | SetF | F-TA98-C500 | 29 | ITVCONC | Intervention Article Concentration | 500 | | 31 | 8325064 | TX | SetF | F-TA98-C500 | 30 | ITVCONCU | Intervention Article Concentration Unit | ug/plate | | 32 | 8325064 | TX | SetF | F-TA98-C500 | 31 | TRTV | Treatment Vehicle | DMSO | | 33 | 8325064 | TX | SetG | G-TA98-C1600 | 31 | PSETCD | Parent Set Code | SetSTM | | 34 | 8325064 | TX | SetG | G-TA98-C1600 | 32 | STRAIN | Strain/Substrain | TA98 | | 35 | 8325064 | TX | SetG | G-TA98-C1600 | 33 | METACTIND | Metabolic Activating Agent Name | NOT APPLICABLE | | 36 | 8325064 | TX | SetG | G-TA98-C1600 | 34 | METACTFL | Presence of Metabolic Activation Flag | N | | 37 | 8325064 | TX | SetG | G-TA98-C1600 | 35 | ITVNAM | Intervention Article Name | TA1 | | 38 | 8325064 | TX | SetG | G-TA98-C1600 | 36 | ITVTYPE | Intervention Article Type | Product | | 39 | 8325064 | TX | SetG | G-TA98-C1600 | 37 | ITVCONC | Intervention Article Concentration | 1600 | | 40 | 8325064 | TX | SetG | G-TA98-C1600 | 38 | ITVCONCU | Intervention Article Concentration Unit | ug/plate | | 41 | 8325064 | TX | SetG | G-TA98-C1600 | 39 | TRTV | Treatment Vehicle | DMSO | | 42 | 8325064 | TX | SetR | R-TA100-C2 | 39 | PSETCD | Parent Set Code | SetSTM | | 43 | 8325064 | TX | SetR | R-TA100-C2 | 40 | STRAIN | Strain/Substrain | TA100 | | 44 | 8325064 | TX | SetR | R-TA100-C2 | 41 | METACTIND | Metabolic Activating Agent Name | NOT APPLICABLE | | 45 | 8325064 | TX | SetR | R-TA100-C2 | 42 | METACTFL | Presence of Metabolic Activation Flag | N | | 46 | 8325064 | TX | SetR | R-TA100-C2 | 43 | ITVNAM | Intervention Article Name | NaN3 | | 47 | 8325064 | TX | SetR | R-TA100-C2 | 44 | ITVTYPE | Intervention Article Type | Positive Control | | 48 | 8325064 | TX | SetR | R-TA100-C2 | 45 | ITVCONC | Intervention Article Concentration | 2 | | 49 | 8325064 | TX | SetR | R-TA100-C2 | 46 | ITVCONCU | Intervention Article Concentration Unit | ug/plate | | 50 | 8325064 | TX | SetR | R-TA100-C2 | 47 | TRTV | Treatment Vehicle | DMSO |
THIS IS A DRAFTED MOCK-UP OF THE "flattened" version of TX dataset: | 8325064 | TX | SetR | R-TA100-C2 | 47 | TRTV | Treatment Vehicle | DMSO |
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REFID values are defined by the applicant to uniquely identify the observational unit within an experimental unit. In the simplified diagram of an assay procedure (below), the test tube that contains the possible mutagen is an example of an entity that would have a REFID indicating information at the level of trial set. The petri plate created from that test tube and used to count revertant numbers is an example of an entity that would be at an observational level.
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