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Comment: TOBA-458

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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

 

RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

1

SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

2IVTDMINIn vitro Treatment Duration Minimum71.5
38325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM3IVTDTRGIn vitro Treatment Duration Target72
48325064AmesTXSetSTMSALMONELLA TYPHIMURIUM4IVTDMAXIn vitro Treatment Duration Maximum72.5
58325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

5IVTDUIn vitro Treatment Duration UnitHOURS
68325064AmesTXSetSTMSALMONELLA TYPHIMURIUM6INCBTMPIncubation Temperature37
78325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM7INCBTMPUIncubation Temperature UnitC
88325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

8ATMRHPAtmospheric Relative Humidity Percent50
98325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM9ATMCO2PAtmospheric CO2 Percent5
108325064AmesTXSetSTMSALMONELLA TYPHIMURIUM10SPTOBID

Applicant-defined tobacco identifier

CIG01a
118325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

11EXPTYP

Exposure Type

Submerged
128325064AmesTXSetSTMSALMONELLA TYPHIMURIUM12SAMTYP

Sample Type

Total Particulate Matter in PBS
138325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

13SPDEVIDApplicant-defined device identifierPUFFMASTER3K
148325064AmesTXSetSTMSALMONELLA TYPHIMURIUM14SMKRGMSmoking RegimenNON-INTENSE REGIMEN
158325064AmesTXSetAA-TA98-C015PSETCDParent Set CodeSetSTM
168325064AmesTXSetAA-TA98-C015STRAINStrain/SubstrainTA98
178325064AmesTX

SetA

A-TA98-C016METACTINDMetabolic Activating Agent NameNOT APPLICABLE
188325064AmesTX

SetA

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

Intervention Article Name

TA1DMSO
208325064AmesTXSetAA-TA98-C019ITVTYPE

Intervention Article Type

Vehicle ControlVEHICLE
218325064AmesTXSetAA-TA98-C020ITVCONCIntervention Article Concentration0100
228325064AmesTXSetAA-TA98-C021ITVCONCUIntervention Article Concentration Unitug/plate%
238325064AmesTXSetAA-TA98-C022TRTVTreatment VehicleDMSO
248325064AmesTXSetF

F-TA98-C500

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


PSETCDParent Set CodeSetSTM
258325064AmesTXSetFF-TA98-C50023STRAINStrain/SubstrainTA98
268325064AmesTXSetFF-TA98-C50024METACTINDMetabolic Activating Agent NameNOT APPLICABLE
278325064AmesTXSetFF-TA98-C50025METACTFLPresence of Metabolic Activation FlagN
288325064AmesTXSetFF-TA98-C50026ITVNAM

Intervention Article Name

TA1
298325064AmesTXSetFF-TA98-C50027ITVTYPE

Intervention Article Type

ProductPRODUCT
308325064AmesTXSetFF-TA98-C50028ITVCONCIntervention Article Concentration500
318325064AmesTXSetFF-TA98-C50029ITVCONCUIntervention Article Concentration Unitug/plate
328325064AmesTXSetFF-TA98-C50030TRTVTreatment VehicleDMSO
338325064AmesTXSetGG-TA98-C160031PSETCDParent Set CodeSetSTM
348325064AmesTXSetGG-TA98-C160031STRAINStrain/SubstrainTA98
358325064AmesTXSetGG-TA98-C160032METACTINDMetabolic Activating Agent NameNOT APPLICABLE
368325064AmesTXSetGG-TA98-C160033METACTFLPresence of Metabolic Activation FlagN
378325064AmesTXSetGG-TA98-C160034ITVNAM

Intervention Article Name

TA1
388325064AmesTXSetGG-TA98-C160035ITVTYPE

Intervention Article Type

Product
398325064AmesTXSetGG-TA98-C160036ITVCONCIntervention Article Concentration1600
408325064AmesTXSetGG-TA98-C160037ITVCONCUIntervention Article Concentration Unitug/plate
418325064AmesTXSetGG-TA98-C160038TRTVTreatment VehicleDMSO
428325064AmesTX

SetR

R-TA100-C239PSETCDParent Set CodeSetSTM
438325064AmesTX

SetR

R-TA100-C239STRAINStrain/SubstrainTA100
448325064AmesTX

SetR

R-TA100-C240METACTINDMetabolic Activating Agent NameNOT APPLICABLE
458325064AmesTX

SetR

R-TA100-C241METACTFLPresence of Metabolic Activation FlagN
468325064AmesTX

SetR

R-TA100-C242ITVNAM

Intervention Article Name

NaN3
478325064AmesTX

SetR

R-TA100-C243ITVTYPE

Intervention Article Type

Positive Control
488325064AmesTX

SetR

R-TA100-C244ITVCONCIntervention Article Concentration2
498325064AmesTX

SetR

R-TA100-C245ITVCONCUIntervention Article Concentration Unitug/plate
508325064AmesTX

SetR

R-TA100-C246TRTVTreatment VehicleDMSO

...

Dataset wrap
Namerelref
Rowcaps
Row 1:

Shows the value of REFID=STM. This REFID refers to the trial set with a SETCD of "SetSTM"

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-489
, 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
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-668

Dataset2
tableidrelref.xpt

Row

STUDYID

GNTXAID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

8325064

Ames

SetSTM

STM


1

TRIAL SET

2

8325064

Ames

SetA

A

STM

2

EXPERIMENTAL UNIT/TRIAL SET

3

8325064

Ames

SetA

1_1

A

3

OBSERVATIONAL UNIT

4

8325064

Ames

SetA

1_2

A

3

OBSERVATIONAL UNIT

5

8325064

Ames

SetA

1_3

A

3

OBSERVATIONAL UNIT

6

8325064

Ames

SetA

1_4

A

3

OBSERVATIONAL UNIT

7

8325064

Ames

SetA

1_5

A

3

OBSERVATIONAL UNIT

8

8325064

Ames

SetF

F

STM

2

EXPERIMENTAL UNIT/TRIAL SET

9

8325064

Ames

SetF6_1F

3

OBSERVATIONAL UNIT

10

8325064

Ames

SetF6_2F

3

OBSERVATIONAL UNIT

11

8325064

Ames

SetF

6_3F

3

OBSERVATIONAL UNIT

12

8325064

Ames

SetG

G

STM

2

EXPERIMENTAL UNIT/TRIAL SET

13

8325064

Ames

SetG7_1G

3

OBSERVATIONAL UNIT

14

8325064

Ames

SetG

7_2G

3

OBSERVATIONAL UNIT

15

8325064

Ames

SetG7_3G

3

OBSERVATIONAL UNIT

16

8325064

Ames

SetG

R

STM

2

EXPERIMENTAL UNIT/TRIAL SET

17

8325064

Ames

SetR18_1R

3

OBSERVATIONAL UNIT

18

8325064

Ames

SetR18_2R

3

OBSERVATIONAL UNIT

19

8325064

Ames

SetR18_3R

3

OBSERVATIONAL UNIT

...