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Comment: TOBA-483

...

Dataset wrap
Nametx
Rows 15-23
Rowcaps
Rows 1-14:Show trial conditions that are common to all trial sets with the species S. typhimurium.  Similar rows are present in each of the trial sets.
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.

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.
1-22:

Show trial set parameters and trial set values that are the test conditions specific to set SetA which is 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
23-
32
44:

Show trial set parameters and trial set values that comprise the test conditions for the set SetF which is 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
45-
41
66:Show trial set parameters and trial set values that comprise the test conditions for the set SetG which 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
67-
50
88:Show trial set parameters and trial set values that comprise the test conditions for the set SetR which 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.
Dataset2

 

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064TXSetAA-TA98-C01SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064TXSetAA-TA98-C02IVTDMINIn vitro Treatment Duration Minimum71.5
38325064TX

SetA

A-TA98-C03IVTDTRGIn vitro Treatment Duration Target72
48325064TX

SetA

A-TA98-C04IVTDMAXIn vitro Treatment Duration Maximum72.5
58325064TXSetAA-TA98-C05IVTDUIn vitro Treatment Duration UnitHOURS
68325064TXSetAA-TA98-C06INCBTMPIncubation Temperature37
78325064TXSetAA-TA98-C07INCBTMPUIncubation Temperature UnitC
88325064TXSetAA-TA98-C08ATMRHPAtmospheric Relative Humidity Percent50
98325064TXSetAA-TA98-C09ATMCO2PAtmospheric CO2 Percent5
108325064TXSetAA-TA98-C010SPTOBID

Applicant-defined tobacco identifier

CIG01a
118325064TXSetAA-TA98-C011EXPTYP

Exposure Type

Submerged
128325064TX

SetA

A-TA98-C012SAMTYP

Sample Type

Total Particulate Matter in PBS
138325064TX

SetA

A-TA98-C013SPDEVIDApplicant-defined device identifierPUFFMASTER3K
148325064TXSetAA-TA98-C014SMKRGMSmoking RegimenNON-INTENSE REGIMEN
15
16168325064TXSetAA-TA98-C015
158325064TXSetAA-TA98-C015
PSETCDParent Set CodeSetSTM17
STRAINStrain/SubstrainTA98
17
168325064TXSetAA-TA98-C016METACTINDMetabolic Activating Agent NameNOT APPLICABLE
18
17
18
8325064TXSetAA-TA98-C017METACTFLPresence of Metabolic Activation FlagN
19
18
1920
8325064TXSetAA-TA98-C018ITVNAM

Intervention Article Name

DMSO
20
198325064TXSetAA-TA98-C019ITVTYPE

Intervention Article Type

VEHICLE
21
20
21
8325064TXSetAA-TA98-C020ITVCONCIntervention Article Concentration100
22
21
2223
8325064TXSetAA-TA98-C021ITVCONCUIntervention Article Concentration Unit%
23
228325064TXSetAA-TA98-C022TRTVTreatment VehicleDMSO
24
238325064TXSetFF-TA98-C50023SPECIESSpeciesSALMONELLA TYPHIMURIUM
25
248325064TXSetFF-TA98-C50024IVTDMINIn vitro Treatment Duration Minimum71.5
26
258325064TXSetFF-TA98-C50025IVTDTRGIn vitro Treatment Duration Target72
27
268325064TXSetFF-TA98-C50026IVTDMAXIn vitro Treatment Duration Maximum72.5
28
278325064TXSetFF-TA98-C50027IVTDUIn vitro Treatment Duration UnitHOURS
29
288325064TXSetFF-TA98-C50028INCBTMPIncubation Temperature37
30
298325064TXSetFF-TA98-C50029INCBTMPUIncubation Temperature UnitC
31
308325064TXSetFF-TA98-C50030ATMRHPAtmospheric Relative Humidity Percent50
32
318325064TXSetFF-TA98-C50031ATMCO2PAtmospheric CO2 Percent5
33
328325064TXSetFF-TA98-C50032SPTOBID

Applicant-defined tobacco identifier

CIG01a
34
338325064TXSetFF-TA98-C50033EXPTYP

Exposure Type

Submerged
35
348325064TXSetFF-TA98-C50034SAMTYP

Sample Type

Total Particulate Matter in PBS
36
358325064TXSetFF-TA98-C50035SPDEVIDApplicant-defined device identifierPUFFMASTER3K
3724
368325064TXSetFF-TA98-C50036SMKRGMSmoking RegimenNON-INTENSE REGIMEN
38
378325064TXSetFF-TA98-C500
jira
37
showSummary
STRAIN
false
Strain/Substrain
serverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-485
TA98
388325064TXSetFF-TA98-C50038METACTINDMetabolic Activating
23PSETCDParent Set CodeSetSTM39258325064TXSetFF-TA98-C50024STRAINStrain/SubstrainTA9840268325064TXSetFF-TA98-C50025METACTINDMetabolic Activating 27
Agent NameNOT APPLICABLE
41
398325064TXSetFF-TA98-C500
26
39METACTFLPresence of Metabolic Activation FlagN
42
40
28
8325064TXSetFF-TA98-C500
2729
40ITVNAM

Intervention Article Name

TA1
43
418325064TXSetFF-TA98-C500
28
41ITVTYPE

Intervention Article Type

PRODUCT
44
42
30
8325064TXSetFF-TA98-C500
2931
42ITVCONCIntervention Article Concentration500
45
438325064TXSetFF-TA98-C500
30
43ITVCONCUIntervention Article Concentration Unitug/plate
468325064
44
32
8325064TXSetFF-TA98-C500
31
44TRTVTreatment VehicleDMSO
47
458325064TXSetGG-TA98-C160045SPECIESSpeciesSALMONELLA TYPHIMURIUM
48
468325064TXSetGG-TA98-C160046IVTDMINIn vitro Treatment Duration Minimum71.5
49
478325064TXSetGG-TA98-C160047IVTDTRGIn vitro Treatment Duration Target72
50
488325064TXSetGG-TA98-C160048IVTDMAXIn vitro Treatment Duration Maximum72.5
51
498325064TXSetGG-TA98-C160049IVTDUIn vitro Treatment Duration UnitHOURS
52
508325064TXSetGG-TA98-C160050INCBTMPIncubation Temperature37
53
518325064TXSetGG-TA98-C160051INCBTMPUIncubation Temperature UnitC
54
528325064TXSetGG-TA98-C160052ATMRHPAtmospheric Relative Humidity Percent50
55
538325064TXSetGG-TA98-C160053ATMCO2PAtmospheric CO2 Percent5
56
548325064TXSetGG-TA98-C160054SPTOBID

Applicant-defined tobacco identifier

CIG01a
57
558325064TXSetGG-TA98-C160055EXPTYP

Exposure Type

Submerged
58
568325064TXSetGG-TA98-C160056SAMTYP

Sample Type

Total Particulate Matter in PBS
59
578325064TXSetGG-TA98-C160057SPDEVIDApplicant-defined device identifierPUFFMASTER3K
60
588325064TXSetGG-TA98-C160058SMKRGMSmoking RegimenNON-INTENSE REGIMEN
61
59
33
8325064TXSetGG-TA98-C1600
31
59
PSETCDParent Set CodeSetSTM
STRAINStrain/SubstrainTA98
60
6234
8325064TXSetGG-TA98-C1600
32
60
STRAINStrain/SubstrainTA9863358325064TXSetGG-TA98-C160033METACTIND
METACTINDMetabolic
Metabolic
Activating Agent NameNOT APPLICABLE
64
61
36
8325064TXSetGG-TA98-C1600
34
61METACTFLPresence of Metabolic Activation FlagN
65
62
37
8325064TXSetGG-TA98-C1600
3538
62ITVNAM

Intervention Article Name

TA1
66
638325064TXSetGG-TA98-C1600
36
63ITVTYPE

Intervention Article Type

Product
67
64
39
8325064TXSetGG-TA98-C1600
3740
64ITVCONCIntervention Article Concentration1600
68
658325064TXSetGG-TA98-C1600
38
65ITVCONCUIntervention Article Concentration Unitug/plate
69
66
41
8325064TXSetGG-TA98-C1600
39
66TRTVTreatment VehicleDMSO
70
678325064TX

SetR

R-TA100-C267SPECIESSpeciesSALMONELLA TYPHIMURIUM
71
688325064TX

SetR

R-TA100-C268IVTDMINIn vitro Treatment Duration Minimum71.5
72
698325064TX

SetR

R-TA100-C269IVTDTRGIn vitro Treatment Duration Target72
73
708325064TX

SetR

R-TA100-C270IVTDMAXIn vitro Treatment Duration Maximum72.5
74
718325064TX

SetR

R-TA100-C271IVTDUIn vitro Treatment Duration UnitHOURS
75
728325064TX

SetR

R-TA100-C272INCBTMPIncubation Temperature37
76
738325064TX

SetR

R-TA100-C273INCBTMPUIncubation Temperature UnitC
77
748325064TX

SetR

R-TA100-C274ATMRHPAtmospheric Relative Humidity Percent50
78
758325064TX

SetR

R-TA100-C275ATMCO2PAtmospheric CO2 Percent5
79
768325064TX

SetR

R-TA100-C276SPTOBID

Applicant-defined tobacco identifier

CIG01a
80
778325064TX

SetR

R-TA100-C277EXPTYP

Exposure Type

Submerged
81
788325064TX

SetR

R-TA100-C278SAMTYP

Sample Type

Total Particulate Matter in PBS
82
798325064TX

SetR

R-TA100-C279SPDEVIDApplicant-defined device identifierPUFFMASTER3K
83
808325064TX

SetR

R-TA100-C280SMKRGMSmoking RegimenNON-INTENSE REGIMEN
84
81
4285438325064TX

SetR

R-TA100-C240
8325064TX

SetR

R-TA100-C2
39PSETCDParent Set CodeSetSTM
81
44
STRAINStrain/SubstrainTA100
86
828325064TX

SetR

R-TA100-C2
41
82METACTINDMetabolic Activating Agent NameNOT APPLICABLE
87
83
45
8325064TX

SetR

R-TA100-C2
4246
83METACTFLPresence of Metabolic Activation FlagN
88
848325064TX

SetR

R-TA100-C2
43
84ITVNAM

Intervention Article Name

NaN3
898325064
85
47
8325064TX

SetR

R-TA100-C2
44
85ITVTYPE

Intervention Article Type

Positive Control
90
86
48
8325064TX

SetR

R-TA100-C2
4549
86ITVCONCIntervention Article Concentration2
91
878325064TX

SetR

R-TA100-C2
46
87ITVCONCUIntervention Article Concentration Unitug/plate
92
88
50
8325064TX

SetR

R-TA100-C2
47
88TRTVTreatment 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. 

...

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

OLD TABLE (prior to flattening Parent/Child in TX dataset)

When this table is removed, remove SetSTM from TX.

NEW (remain AFTER we flatten  TX dataset)
Dataset2
tableidrelref.xpt

Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

8325064

SetSTM

STM

1

TRIAL SET

2

8325064

SetA

A

STM

2

EXPERIMENTAL UNIT/TRIAL SET

3

8325064

SetA

1_1

A

3

OBSERVATIONAL UNIT

4

8325064

SetA

1_2

A

3

OBSERVATIONAL UNIT

5

8325064

SetA

1_3

A

3

OBSERVATIONAL UNIT

6

8325064

SetA

1_4

A

3

OBSERVATIONAL UNIT

7

8325064

SetA

1_5

A

3

OBSERVATIONAL UNIT

8

8325064

SetF

F

STM

2

EXPERIMENTAL UNIT/TRIAL SET

9

8325064

SetF6_1F

3

OBSERVATIONAL UNIT

10

8325064

SetF6_2F

3

OBSERVATIONAL UNIT

11

8325064

SetF

6_3F

3

OBSERVATIONAL UNIT

12

8325064

SetG

G

STM

2

EXPERIMENTAL UNIT/TRIAL SET

13

8325064

SetG7_1G

3

OBSERVATIONAL UNIT

14

8325064

SetG

7_2G

3

OBSERVATIONAL UNIT

15

8325064

SetG7_3G

3

OBSERVATIONAL UNIT

16

8325064

SetG

R

STM

2

EXPERIMENTAL UNIT/TRIAL SET

17

8325064

SetR18_1R

3

OBSERVATIONAL UNIT

18

8325064

SetR18_2R

3

OBSERVATIONAL UNIT

19

8325064

SetR18_3R

3

OBSERVATIONAL UNIT

Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

8325064

SetA

A


1

EXPERIMENTAL UNIT/TRIAL SET

2

8325064

SetA

1_1

A

2

OBSERVATIONAL UNIT

3

8325064

SetA

1_2

A

2

OBSERVATIONAL UNIT

4

8325064

SetA

1_3

A

2

OBSERVATIONAL UNIT

5

8325064

SetA

1_4

A

2

OBSERVATIONAL UNIT

6

8325064

SetA

1_5

A

2

OBSERVATIONAL UNIT

7

8325064

SetF

F


1

EXPERIMENTAL UNIT/TRIAL SET

8

8325064

SetF6_1F

2

OBSERVATIONAL UNIT

9

8325064

SetF6_2F

2

OBSERVATIONAL UNIT

10

8325064

SetF

6_3F

2

OBSERVATIONAL UNIT

11

8325064

SetG

G


1

EXPERIMENTAL UNIT/TRIAL SET

12

8325064

SetG7_1G

2

OBSERVATIONAL UNIT

13

8325064

SetG

7_2G

2

OBSERVATIONAL UNIT

14

8325064

SetG7_3G

2

OBSERVATIONAL UNIT

15

8325064

SetG

R


1

EXPERIMENTAL UNIT/TRIAL SET

16

8325064

SetR18_1R

2

OBSERVATIONAL UNIT

17

8325064

SetR18_2R

2

OBSERVATIONAL UNIT

18

8325064

SetR18_3R

2

OBSERVATIONAL UNIT

...