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This example Trial Set (TX) dataset shows information about the test conditions for SetA and SetR in this study. For brevity, the dataset does not show information for SetF, SetG, or any other sets.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-483

A fully formed TX dataset for this example study would include information about the test conditions for all sets.

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Name	tx

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Note that there are three trial set parameters that link to other important datasets: SPTOBID, APDEVID, and SMKRGM.

SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID

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(e.g., 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.

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The TO domain is described in Section 2.8.8.1, Tobacco Product Identifiers and Descriptors (TO).

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The value of APDEVID

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(e.g., PUFFMASTER3K) matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. 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)). This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1.

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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.

Dataset wrap

Name	tx

Rowcaps

Rows 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

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-666

Rows 23-44:

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

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-667

Rows 45-66:

Show trial set parameters and trial set values that comprise the test conditions for the set SetG which is 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 67-88:

Show trial set parameters and trial set values that comprise the test conditions for the set SetR which is 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

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	TX	SetA	A-TA98-C0	1	SPECIES	Species	SALMONELLA TYPHIMURIUM
2	8325064	TX	SetA	A-TA98-C0	2	IVTDMIN	In vitro Treatment Duration Minimum	71.5
3	8325064	TX	SetA	A-TA98-C0	3	IVTDTRG	In vitro Treatment Duration Target	72
4	8325064	TX	SetA	A-TA98-C0	4	IVTDMAX	In vitro Treatment Duration Maximum	72.5
5	8325064	TX	SetA	A-TA98-C0	5	IVTDU	In vitro Treatment Duration Unit	HOURS
6	8325064	TX	SetA	A-TA98-C0	6	INCBTMP	Incubation Temperature	37
7	8325064	TX	SetA	A-TA98-C0	7	INCBTMPU	Incubation Temperature Unit	C
8	8325064	TX	SetA	A-TA98-C0	8	ATMRHP	Atmospheric Relative Humidity Percent	50
9	8325064	TX	SetA	A-TA98-C0	9	ATMCO2P	Atmospheric CO2 Percent	5
10	8325064	TX	SetA	A-TA98-C0	10	SPTOBID	Applicant-defined tobacco identifier	CIG01a
11	8325064	TX	SetA	A-TA98-C0	11	EXPTYP	Exposure Type	Submerged
12	8325064	TX	SetA	A-TA98-C0	12	SAMTYP	Sample Type	Total Particulate Matter in PBS
13	8325064	TX	SetA	A-TA98-C0	13	APDEVID	Applicant-defined device identifier	PUFFMASTER3K
14	8325064	TX	SetA	A-TA98-C0	14	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
15	8325064	TX	SetA	A-TA98-C0	15	STRAIN	Strain/Substrain	TA98
16	8325064	TX	SetA	A-TA98-C0	16	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
17	8325064	TX	SetA	A-TA98-C0	17	METACTFL	Presence of Metabolic Activation Flag	N
18	8325064	TX	SetA	A-TA98-C0	18	ITVNAM	Intervention Article Name	DMSO
19	8325064	TX	SetA	A-TA98-C0	19	ITVTYPE	Intervention Article Type	VEHICLE
20	8325064	TX	SetA	A-TA98-C0	20	ITVCONC	Intervention Article Concentration	100
21	8325064	TX	SetA	A-TA98-C0	21	ITVCONCU	Intervention Article Concentration Unit	%
22	8325064	TX	SetA	A-TA98-C0	22	TRTV	Treatment Vehicle	DMSO
23	8325064	TX	SetF	F-TA98-C500	23	SPECIES	Species	SALMONELLA TYPHIMURIUM
24	8325064	TX	SetF	F-TA98-C500	24	IVTDMIN	In vitro Treatment Duration Minimum	71.5
25	8325064	TX	SetF	F-TA98-C500	25	IVTDTRG	In vitro Treatment Duration Target	72
26	8325064	TX	SetF	F-TA98-C500	26	IVTDMAX	In vitro Treatment Duration Maximum	72.5
27	8325064	TX	SetF	F-TA98-C500	27	IVTDU	In vitro Treatment Duration Unit	HOURS
28	8325064	TX	SetF	F-TA98-C500	28	INCBTMP	Incubation Temperature	37
29	8325064	TX	SetF	F-TA98-C500	29	INCBTMPU	Incubation Temperature Unit	C
30	8325064	TX	SetF	F-TA98-C500	30	ATMRHP	Atmospheric Relative Humidity Percent	50
31	8325064	TX	SetF	F-TA98-C500	31	ATMCO2P	Atmospheric CO2 Percent	5
32	8325064	TX	SetF	F-TA98-C500	32	SPTOBID	Applicant-defined tobacco identifier	CIG01a
33	8325064	TX	SetF	F-TA98-C500	33	EXPTYP	Exposure Type	Submerged
34	8325064	TX	SetF	F-TA98-C500	34	SAMTYP	Sample Type	Total Particulate Matter in PBS
35	8325064	TX	SetF	F-TA98-C500	35	APDEVID	Applicant-defined device identifier	PUFFMASTER3K
36	8325064	TX	SetF	F-TA98-C500	36	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
37	8325064	TX	SetF	F-TA98-C500	37	STRAIN	Strain/Substrain	TA98
38	8325064	TX	SetF	F-TA98-C500	38	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
39	8325064	TX	SetF	F-TA98-C500	39	METACTFL	Presence of Metabolic Activation Flag	N
40	8325064	TX	SetF	F-TA98-C500	40	ITVNAM	Intervention Article Name	TA1
41	8325064	TX	SetF	F-TA98-C500	41	ITVTYPE	Intervention Article Type	PRODUCT
42	8325064	TX	SetF	F-TA98-C500	42	ITVCONC	Intervention Article Concentration	500
43	8325064	TX	SetF	F-TA98-C500	43	ITVCONCU	Intervention Article Concentration Unit	ug/plate
44	8325064	TX	SetF	F-TA98-C500	44	TRTV	Treatment Vehicle	DMSO
45	8325064	TX	SetG	G-TA98-C1600	45	SPECIES	Species	SALMONELLA TYPHIMURIUM
46	8325064	TX	SetG	G-TA98-C1600	46	IVTDMIN	In vitro Treatment Duration Minimum	71.5
47	8325064	TX	SetG	G-TA98-C1600	47	IVTDTRG	In vitro Treatment Duration Target	72
48	8325064	TX	SetG	G-TA98-C1600	48	IVTDMAX	In vitro Treatment Duration Maximum	72.5
49	8325064	TX	SetG	G-TA98-C1600	49	IVTDU	In vitro Treatment Duration Unit	HOURS
50	8325064	TX	SetG	G-TA98-C1600	50	INCBTMP	Incubation Temperature	37
51	8325064	TX	SetG	G-TA98-C1600	51	INCBTMPU	Incubation Temperature Unit	C
52	8325064	TX	SetG	G-TA98-C1600	52	ATMRHP	Atmospheric Relative Humidity Percent	50
53	8325064	TX	SetG	G-TA98-C1600	53	ATMCO2P	Atmospheric CO2 Percent	5
54	8325064	TX	SetG	G-TA98-C1600	54	SPTOBID	Applicant-defined tobacco identifier	CIG01a
55	8325064	TX	SetG	G-TA98-C1600	55	EXPTYP	Exposure Type	Submerged
56	8325064	TX	SetG	G-TA98-C1600	56	SAMTYP	Sample Type	Total Particulate Matter in PBS
57	8325064	TX	SetG	G-TA98-C1600	57	APDEVID	Applicant-defined device identifier	PUFFMASTER3K
58	8325064	TX	SetG	G-TA98-C1600	58	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
59	8325064	TX	SetG	G-TA98-C1600	59	STRAIN	Strain/Substrain	TA98
60	8325064	TX	SetG	G-TA98-C1600	60	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
61	8325064	TX	SetG	G-TA98-C1600	61	METACTFL	Presence of Metabolic Activation Flag	N
62	8325064	TX	SetG	G-TA98-C1600	62	ITVNAM	Intervention Article Name	TA1
63	8325064	TX	SetG	G-TA98-C1600	63	ITVTYPE	Intervention Article Type	Product
64	8325064	TX	SetG	G-TA98-C1600	64	ITVCONC	Intervention Article Concentration	1600
65	8325064	TX	SetG	G-TA98-C1600	65	ITVCONCU	Intervention Article Concentration Unit	ug/plate
66	8325064	TX	SetG	G-TA98-C1600	66	TRTV	Treatment Vehicle	DMSO
67	8325064	TX	SetR	R-TA100-C2	67	SPECIES	Species	SALMONELLA TYPHIMURIUM
68	8325064	TX	SetR	R-TA100-C2	68	IVTDMIN	In vitro Treatment Duration Minimum	71.5
69	8325064	TX	SetR	R-TA100-C2	69	IVTDTRG	In vitro Treatment Duration Target	72
70	8325064	TX	SetR	R-TA100-C2	70	IVTDMAX	In vitro Treatment Duration Maximum	72.5
71	8325064	TX	SetR	R-TA100-C2	71	IVTDU	In vitro Treatment Duration Unit	HOURS
72	8325064	TX	SetR	R-TA100-C2	72	INCBTMP	Incubation Temperature	37
73	8325064	TX	SetR	R-TA100-C2	73	INCBTMPU	Incubation Temperature Unit	C
74	8325064	TX	SetR	R-TA100-C2	74	ATMRHP	Atmospheric Relative Humidity Percent	50
75	8325064	TX	SetR	R-TA100-C2	75	ATMCO2P	Atmospheric CO2 Percent	5
76	8325064	TX	SetR	R-TA100-C2	76	SPTOBID	Applicant-defined tobacco identifier	CIG01a
77	8325064	TX	SetR	R-TA100-C2	77	EXPTYP	Exposure Type	Submerged
78	8325064	TX	SetR	R-TA100-C2	78	SAMTYP	Sample Type	Total Particulate Matter in PBS
79	8325064	TX	SetR	R-TA100-C2	79	APDEVID	Applicant-defined device identifier	PUFFMASTER3K
80	8325064	TX	SetR	R-TA100-C2	80	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
81	8325064	TX	SetR	R-TA100-C2	81	STRAIN	Strain/Substrain	TA100
82	8325064	TX	SetR	R-TA100-C2	82	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
83	8325064	TX	SetR	R-TA100-C2	83	METACTFL	Presence of Metabolic Activation Flag	N
84	8325064	TX	SetR	R-TA100-C2	84	ITVNAM	Intervention Article Name	NaN3
85	8325064	TX	SetR	R-TA100-C2	85	ITVTYPE	Intervention Article Type	Positive Control
86	8325064	TX	SetR	R-TA100-C2	86	ITVCONC	Intervention Article Concentration	2
87	8325064	TX	SetR	R-TA100-C2	87	ITVCONCU	Intervention Article Concentration Unit	ug/plate
88	8325064	TX	SetR	R-TA100-C2	88	TRTV	Treatment Vehicle	DMSO

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This picture does not depict the more complicated procedures,

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-370

trial sets, or observational units for the example study. For study 8325064, the applicant chose to define the REFIDs at the trial set level with a single character (e.g., A, F, G, R) and chose to define REFIDs at the observational level based on the location of each tube in 1 of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).

Image Removed

.g, 6_1 for plate 6, position 1).

Image Added

Dataset wrap

Name	relref

Rowcaps

Row 1

Dataset wrap

Name	relref

Rowcaps

Row 1:

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

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-489

, as defined in the TX dataset. LEVEL=1 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.

Rows 2, 8, 12, 16:

Show that the trial set SetSTM is the parent of set codes SetA, SetF, SetG, and SetR.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-458

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 1 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 32-76:

Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A.

Row 87:

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 1 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 98-1110:

Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F.

Row 1211:

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 1 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 1312-1514:

Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G.

Row 1615:

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 1 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 1716-1918:

Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-668

Dataset2

tableid	relref.xpt

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	SetF	6_1	F	2	OBSERVATIONAL UNIT
9	8325064	SetF	6_2	F	2	OBSERVATIONAL UNIT
10	8325064	SetF	6_3	F	2	OBSERVATIONAL UNIT
11	8325064	SetG	G		1	EXPERIMENTAL UNIT/TRIAL SET
12	8325064	SetG	7_1	G	2	OBSERVATIONAL UNIT
13	8325064	SetG	7_2	G	2	OBSERVATIONAL UNIT
14	8325064	SetG	7_3	G	2	OBSERVATIONAL UNIT
15	8325064	SetR	R		1	EXPERIMENTAL UNIT/TRIAL SET
16	8325064	SetR	18_1	R	2	OBSERVATIONAL UNIT
17	8325064	SetR	18_2	R	2	OBSERVATIONAL UNIT
18	8325064	SetR	18_3	R	2	OBSERVATIONAL UNIT

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