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changes.mady.by.user Julie Chason

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changes.mady.by.user Lou Ann Kramer

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Comment: Mockup of flattened TX dataset is in progress

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Dataset wrap
Nametx
Rowcaps
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
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-666

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
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-667

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.

Dataset2

 THIS (RED FONT)  IS THE OLD DATASET PRIOR TO "flattening":

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064TX

SetSTM

SALMONELLA TYPHIMURIUM

1

SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064TXSetSTM

SALMONELLA TYPHIMURIUM

2IVTDMINIn vitro Treatment Duration Minimum71.5
38325064TX

SetSTM

SALMONELLA TYPHIMURIUM3IVTDTRGIn vitro Treatment Duration Target72
48325064TXSetSTMSALMONELLA TYPHIMURIUM4IVTDMAXIn vitro Treatment Duration Maximum72.5
58325064TX

SetSTM

SALMONELLA TYPHIMURIUM

5IVTDUIn vitro Treatment Duration TreatmentRowDuration UnitHOURS
68325064TXSetSTMSALMONELLA TYPHIMURIUM6INCBTMPIncubation Temperature37
78325064TX

SetSTM

SALMONELLA TYPHIMURIUM7INCBTMPUIncubation Temperature UnitC
88325064TXSetSTM

SALMONELLA TYPHIMURIUM

8ATMRHPAtmospheric Relative Humidity Percent50
98325064TX

SetSTM

SALMONELLA TYPHIMURIUM9ATMCO2PAtmospheric CO2 Percent5
108325064TXSetSTMSALMONELLA TYPHIMURIUM10SPTOBID

Applicant-defined tobacco identifier

CIG01a
118325064TX

SetSTM

SALMONELLA TYPHIMURIUM

11EXPTYP

Exposure Type

Submerged
128325064TXSetSTMSALMONELLA TYPHIMURIUM12SAMTYP

Sample Type

Total Particulate Matter in PBS
138325064TXSetSTM

SALMONELLA TYPHIMURIUM

13SPDEVIDApplicant-defined device identifierPUFFMASTER3K
148325064TXSetSTMSALMONELLA TYPHIMURIUM14SMKRGMSmoking RegimenNON-INTENSE REGIMEN
158325064TXSetAA-TA98-C015PSETCDParent Set CodeSetSTM
168325064TXSetAA-TA98-C015STRAINStrain/SubstrainTA98
178325064TX

SetA

A-TA98-C016METACTINDMetabolic Activating Agent NameNOT APPLICABLE
188325064TX

SetA

A-TA98-C017METACTFLPresence of Metabolic Activation FlagN
198325064TXSetAA-TA98-C018ITVNAM

Intervention Article Name

DMSO
208325064TXSetAA-TA98-C019ITVTYPE

Intervention Article Type

VEHICLE
218325064TXSetAA-TA98-C020ITVCONCIntervention Article Concentration100
228325064TXSetAA-TA98-C021ITVCONCUIntervention Article Concentration Unit%
238325064TXSetAA-TA98-C022TRTVTreatment VehicleDMSO
248325064TXSetF

F-TA98-C500

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-485

23PSETCDParent Set CodeSetSTM
258325064TXSetFF-TA98-C50024STRAINStrain/SubstrainTA98
268325064TXSetFF-TA98-C50025METACTINDMetabolic Activating Agent NameNOT APPLICABLE
278325064TXSetFF-TA98-C50026METACTFLPresence of Metabolic Activation FlagN
288325064TXSetFF-TA98-C50027ITVNAM

Intervention Article Name

TA1
298325064TXSetFF-TA98-C50028ITVTYPE

Intervention Article Type

PRODUCT
308325064TXSetFF-TA98-C50029ITVCONCIntervention Article Concentration500
318325064TXSetFF-TA98-C50030ITVCONCUIntervention Article Concentration Unitug/plate
328325064TXSetFF-TA98-C50031TRTVTreatment VehicleDMSO
338325064TXSetGG-TA98-C160031PSETCDParent Set CodeSetSTM
348325064TXSetGG-TA98-C160032STRAINStrain/SubstrainTA98
358325064TXSetGG-TA98-C160033METACTINDMetabolic Activating Agent NameNOT APPLICABLE
368325064TXSetGG-TA98-C160034METACTFLPresence of Metabolic Activation FlagN
378325064TXSetGG-TA98-C160035ITVNAM

Intervention Article Name

TA1
388325064TXSetGG-TA98-C160036ITVTYPE

Intervention Article Type

Product
398325064TXSetGG-TA98-C160037ITVCONCIntervention Article Concentration1600
408325064TXSetGG-TA98-C160038ITVCONCUIntervention Article Concentration Unitug/plate
418325064TXSetGG-TA98-C160039TRTVTreatment VehicleDMSO
428325064TX

SetR

R-TA100-C239PSETCDParent Set CodeSetSTM
438325064TX

SetR

R-TA100-C240STRAINStrain/SubstrainTA100
448325064TX

SetR

R-TA100-C241METACTINDMetabolic Activating Agent NameNOT APPLICABLE
458325064TX

SetR

R-TA100-C242METACTFLPresence of Metabolic Activation FlagN
468325064TX

SetR

R-TA100-C243ITVNAM

Intervention Article Name

NaN3
478325064TX

SetR

R-TA100-C244ITVTYPE

Intervention Article Type

Positive Control
488325064TX

SetR

R-TA100-C245ITVCONCIntervention Article Concentration2
498325064TX

SetR

R-TA100-C246ITVCONCUIntervention Article Concentration Unitug/plate
508325064TX

SetR

R-TA100-C247TRTVTreatment VehicleDMSO


THIS IS A DRAFTED MOCK-UP OF THE "flattened" version of TX dataset:

STUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064TX

SetSTM

SALMONELLA TYPHIMURIUM

1

SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064TXSetSTM

SALMONELLA TYPHIMURIUM

2IVTDMINIn vitro Treatment Duration Minimum71.5
38325064TX

SetSTM

SALMONELLA TYPHIMURIUM3IVTDTRGIn vitro Treatment Duration Target72
48325064TXSetSTMSALMONELLA TYPHIMURIUM4IVTDMAXIn vitro Treatment Duration Maximum72.5
58325064TX

SetSTM

SALMONELLA TYPHIMURIUM

5IVTDUIn vitro TreatmentRowDuration UnitHOURS
68325064TXSetSTMSALMONELLA TYPHIMURIUM6INCBTMPIncubation Temperature37
78325064TX

SetSTM

SALMONELLA TYPHIMURIUM7INCBTMPUIncubation Temperature UnitC
88325064TXSetSTM

SALMONELLA TYPHIMURIUM

8ATMRHPAtmospheric Relative Humidity Percent50
98325064TX

SetSTM

SALMONELLA TYPHIMURIUM9ATMCO2PAtmospheric CO2 Percent5
108325064TXSetSTMSALMONELLA TYPHIMURIUM10SPTOBID

Applicant-defined tobacco identifier

CIG01a
118325064TX

SetSTM

SALMONELLA TYPHIMURIUM

11EXPTYP

Exposure Type

Submerged
128325064TXSetSTMSALMONELLA TYPHIMURIUM12SAMTYP

Sample Type

Total Particulate Matter in PBS
138325064TXSetSTM

SALMONELLA TYPHIMURIUM

13SPDEVIDApplicant-defined device identifierPUFFMASTER3K
148325064TXSetSTMSALMONELLA TYPHIMURIUM14SMKRGMSmoking RegimenNON-INTENSE REGIMEN
158325064TXSetAA-TA98-C0

1

SPECIESSpeciesSALMONELLA TYPHIMURIUM
168325064TXSetAA-TA98-C02IVTDMINIn vitro Treatment Duration Minimum71.5
178325064TX

SetA

A-TA98-C03IVTDTRGIn vitro Treatment Duration Target72
188325064TX

SetA

A-TA98-C04IVTDMAXIn vitro Treatment Duration Maximum72.5
198325064TXSetAA-TA98-C05IVTDUIn vitro TreatmentRowDuration UnitHOURS
208325064TXSetAA-TA98-C06INCBTMPIncubation Temperature37
218325064TXSetAA-TA98-C07INCBTMPUIncubation Temperature UnitC
228325064TXSetAA-TA98-C08ATMRHPAtmospheric Relative Humidity Percent50
238325064TXSetAA-TA98-C09ATMCO2PAtmospheric CO2 Percent5
248325064TXSetAA-TA98-C010SPTOBID

Applicant-defined tobacco identifier

CIG01a
258325064TXSetAA-TA98-C011EXPTYP

Exposure Type

Submerged
268325064TX

SetA

A-TA98-C012SAMTYP

Sample Type

Total Particulate Matter in PBS
278325064TX

SetA

A-TA98-C013SPDEVIDApplicant-defined device identifierPUFFMASTER3K
288325064TXSetAA-TA98-C014SMKRGMSmoking RegimenNON-INTENSE REGIMEN
298325064TXSetAA-TA98-C015PSETCDParent Set CodeSetSTM
308325064TXSetAA-TA98-C015STRAINStrain/SubstrainTA98
318325064TXSetAA-TA98-C016METACTINDMetabolic Activating Agent NameNOT APPLICABLE
328325064TXSetAA-TA98-C017METACTFLPresence of Metabolic Activation FlagN
338325064TXSetAA-TA98-C018ITVNAM

Intervention Article Name

DMSO
348325064TXSetAA-TA98-C019ITVTYPE

Intervention Article Type

VEHICLE
358325064TXSetAA-TA98-C020ITVCONCIntervention Article Concentration100
368325064TXSetAA-TA98-C021ITVCONCUIntervention Article Concentration Unit%
378325064TXSetAA-TA98-C022TRTVTreatment VehicleDMSO
388325064TXSetF

F-TA98-C500

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-485

23PSETCDParent Set CodeSetSTM
398325064TXSetFF-TA98-C50024STRAINStrain/SubstrainTA98
408325064TXSetFF-TA98-C50025METACTINDMetabolic Activating Agent NameNOT APPLICABLE
418325064TXSetFF-TA98-C50026METACTFLPresence of Metabolic Activation FlagN
428325064TXSetFF-TA98-C50027ITVNAM

Intervention Article Name

TA1
438325064TXSetFF-TA98-C50028ITVTYPE

Intervention Article Type

PRODUCT
448325064TXSetFF-TA98-C50029ITVCONCIntervention Article Concentration500
458325064TXSetFF-TA98-C50030ITVCONCUIntervention Article Concentration Unitug/plate
468325064TXSetFF-TA98-C50031TRTVTreatment VehicleDMSO
478325064TXSetGG-TA98-C160031PSETCDParent Set CodeSetSTM
488325064TXSetGG-TA98-C160032STRAINStrain/SubstrainTA98
498325064TXSetGG-TA98-C160033METACTINDMetabolic Activating Agent NameNOT APPLICABLE
508325064TXSetGG-TA98-C160034METACTFLPresence of Metabolic Activation FlagN
518325064TXSetGG-TA98-C160035ITVNAM

Intervention Article Name

TA1
528325064TXSetGG-TA98-C160036ITVTYPE

Intervention Article Type

Product
538325064TXSetGG-TA98-C160037ITVCONCIntervention Article Concentration1600
548325064TXSetGG-TA98-C160038ITVCONCUIntervention Article Concentration Unitug/plate
558325064TXSetGG-TA98-C160039TRTVTreatment VehicleDMSO
568325064TX

SetR

R-TA100-C239PSETCDParent Set CodeSetSTM
578325064TX

SetR

R-TA100-C240STRAINStrain/SubstrainTA100
588325064TX

SetR

R-TA100-C241METACTINDMetabolic Activating Agent NameNOT APPLICABLE
598325064TX

SetR

R-TA100-C242METACTFLPresence of Metabolic Activation FlagN
608325064TX

SetR

R-TA100-C243ITVNAM

Intervention Article Name

NaN3
618325064TX

SetR

R-TA100-C244ITVTYPE

Intervention Article Type

Positive Control
628325064TX

SetR

R-TA100-C245ITVCONCIntervention Article Concentration2
638325064TX

SetR

R-TA100-C246ITVCONCUIntervention Article Concentration Unitug/plate
648325064TX

SetR

R-TA100-C247TRTVTreatment VehicleDMSO

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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