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Dataset wrap

Name	tx

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 Salmonella Typhimurium.
Rows 115-22:	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.
Rows 23-4430:	Show trial set parameters and trial set values that comprise the test conditions for the set SetRSetF. SetR SetF is the data for the vehicle control (i.e., Strain of TA100, positive control strain of TA98 with a concentration value of 2). SetR 500 µg/plate. SetF is associated with the eighteenth sixth row, labeled "SetRSetF", in the report table for example study 8325064.
Rows 13, 3531-38:	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 39-46:	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:	Shows a value for SPTOBID=CIG01a. SPTOBID is Sponsor-Defined Tobacco Product ID that 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 a value for SPTOBID=CIG01a. SPTOBID is Sponsor-Defined Tobacco Product ID that 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 the Section 2.8.8.1 Tobacco Product Identifiers and Descriptors (TO).
Rows 21, 43Row 13:	Show a value for SPDEVID. SPDEVID is the Sponsor defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset. 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.xpt in SDTM Example.Product HPHC ENDS Testing. The DI domain is described in the Section 2.8.9.7 Device Identifiers (DI).
Rows 22, 4414:	Show a value for DUREFID. DUREFID serves as a link to the Device-In Use Properties (DU) domain, where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine, as in the du.xpt in SDTM Example.Product HPHC ENDS Testing. The DU domain is described in the Section 2.8.9.8 Device-In-Use (DU).

Dataset2

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	1	SPECIES	Species	SALMONELLA TYPHIMURIUM
2	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	2	TRTDMIN	Treatment Duration Minimum	71.5
3	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	3	TRTDTRG	Treatment Duration Target	72
4	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	4	TRTDMAX	Treatment Duration Maximum	72.5
5	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	5	TRTDU	Treatment Duration Unit	HOURS
6	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	6	INCBTMP	Incubation Temperature	37
7	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	7	INCBTMPU	Incubation Temperature Unit	C
8	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	8	HUMID	Atmospheric Relative Humidity Percent	50
9	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	9	ATMCO2	Atmospheric CO2 Percent	5
10	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
11	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	11	EXPTYP	Exposure Type	Submerged
12	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	12	SAMTYP	Sample Type	Total Particulate Matter in PBS
13	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	13	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
14	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	14	DUREFID	Smoke Regimen	NON-INTENSE REGIMEN
15	8325064	Ames	TX	SetA	A-TA98-C0	15	STRAIN	Strain/Substrain	TA98
16	8325064	Ames	TX	SetA	A-TA98-C0	16	METACT	Metabolic Activation	NOT APPLICABLE
17	8325064	Ames	TX	SetA	A-TA98-C0	17	METACTFL	Y/N presence of metabolic activation	N
18	8325064	Ames	TX	SetA	A-TA98-C0	18	INTRVN	Name of the intervention article	TA1
19	8325064	Ames	TX	SetA	A-TA98-C0	19	ITVTYPE	Type of intervention article	Vehicle Control
20	8325064	Ames	TX	SetA	A-TA98-C0	20	ITVCONC	Concentration of intervention article	0
21	8325064	Ames	TX	SetA	A-TA98-C0	21	ITVCONCU	Concentration Unit	ug/plate
22	8325064	Ames	TX	SetA	A-TA98-C0	22	TRTV	Treatment Vehicle	DMSO
23	8325064	Ames	TX	SetF	F-TA98-C500	23	STRAIN	Strain/Substrain	TA98
24	8325064	Ames	TX	SetF	F-TA98-C500	24	METACT	Metabolic Activation	NOT APPLICABLE
25	8325064	Ames	TX	SetF	F-TA98-C500	25	METACTFL	Y/N presence of metabolic activation	N
26	8325064	Ames	TX	SetF	F-TA98-C500	26	INTRVN	Name of the intervention article	TA1
27	8325064	Ames	TX	SetF	F-TA98-C500	27	ITVTYPE	Type of intervention article	Product
28	8325064	Ames	TX	SetF	F-TA98-C500	28	ITVCONC	Concentration of intervention article	500
29	8325064	Ames	TX	SetF	F-TA98-C500	29	ITVCONCU	Concentration Unit	ug/plate
30	8325064	Ames	TX	SetF	F-TA98-C500	30	TRTV	Treatment Vehicle	DMSO
31	8325064	Ames	TX	SetG	G-TA98-C1600	31	STRAIN	Strain/Substrain	TA98
32	8325064	Ames	TX	SetG	G-TA98-C1600	32	METACT	Metabolic Activation	NOT APPLICABLE
33	8325064	Ames	TX	SetG	G-TA98-C1600	33	METACTFL	Y/N presence of metabolic activation	N
34	8325064	Ames	TX	SetG	G-TA98-C1600	34	INTRVN	Name of the intervention article	TA1
35	8325064	Ames	TX	SetG	G-TA98-C1600	35	ITVTYPE	Type of intervention article	Product
36	8325064	Ames	TX	SetG	G-TA98-C1600	36	ITVCONC	Concentration of intervention article	1600
37	8325064	Ames	TX	SetG	G-TA98-C1600	37	ITVCONCU	Concentration Unit	ug/plate
38	8325064	Ames	TX	SetG	G-TA98-C1600	38	TRTV	Treatment Vehicle	DMSO
39	8325064	Ames	TX	SetR	R-TA100-C2	39	STRAIN	Strain/Substrain	TA100
40	8325064	Ames	TX	SetR	R-TA100-C2	40	METACT	Metabolic Activation	NOT APPLICABLE
41	8325064	Ames	TX	SetR	R-TA100-C2	41	METACTFL	Y/N presence of metabolic activation	N
42	8325064	Ames	TX	SetR	R-TA100-C2	42	INTRVN	name of the intervention article	NaN3
43	8325064	Ames	TX	SetR	R-TA100-C2	43	ITVTYPE	type of intervention article	Positive Control
44	8325064	Ames	TX	SetR	R-TA100-C2	44	ITVCONC	Concentration of intervention article	2
45	8325064	Ames	TX	SetR	R-TA100-C2	45	ITVCONCU	Concentration Unit	ug/plate
46	8325064	Ames	TX	SetR	R-TA100-C2	46	TRTV	Treatment Vehicle	DMSO

REFID values are defined by the applicant to uniquely identify the observational unit within an experimental unit. In the simplified picture of an assay (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.

This picture does not depict the more complicated procedures, trial sets, or observational units for our example study, 8325064. 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 one of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).

Image Removed

be at an observational level.

This picture does not depict the more complicated procedures, trial sets, or observational units for our example study, 8325064. 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 one of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).

Image Added

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', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.
Rows 1,2,8,12,16:	Shows that the trial set, SetSTM, is the parent of set codes SetA, SetF, SetG, and SetR.
Row 2

Dataset wrap

Name	relref

Rowcaps

Row 1

:	Shows the value of REFID=A, This REFID refers to the trial set with a SETCD of 'SetA', as defined in the trial set dataset, tx.xpt. LEVEL=

1

2 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.

Rows

2

3-

6

7:	Show the values of five observational units

0

1_1 through

0

1_5 that are within the parent experimental unit, REFID=A

Row

7

8:	Shows the value of REFID=F, This REFID refers to the trial set with a SETCD of 'SetF', as defined in the trial set dataset, tx.xpt. LEVEL=

1

2 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.

Rows

8

9-

10

11:	Show the values of three observational units 6_1 through 6_3 that are within the parent experimental unit, REFID=F
Row

11

12:	Shows the value of REFID=G, This REFID refers to the trial set with a SETCD of 'SetG', as defined in the trial set dataset, tx.xpt. LEVEL=

1

2 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.

Rows

12

13-

14

15:	Show the values of three observational units 7_1 through 7_3 that are within the parent experimental unit, REFID=

F

G

Row

15

16:	Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of 'SetG', as defined in the trial set dataset, tx.xpt. LEVEL=

1

2 and LVLDESC='TRIAL SET' indicates this identifier relates to the entire trial set.

Rows

16

17-

18

19:	Show the values of three observational units 18_1 through 18_3 that are within the parent experimental unit, REFID=

F

R

Dataset2

tableid	relref.xpt

121314151617

Row	STUDYID	GNTXAID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	8325064	Ames	SetSTM	STM		1	TRIAL SET
12	8325064	Ames	SetA	A	STM	2	TRIAL SET
23	8325064	Ames	SetA	1_1	A	3	OBSERVATIONAL UNIT
34	8325064	Ames	SetA	1_2	A	3	OBSERVATIONAL UNIT
45	8325064	Ames	SetA	1_3	A	3	OBSERVATIONAL UNIT
56	8325064	Ames	SetA	1_4	A	3	OBSERVATIONAL UNIT
67	8325064	Ames	SetA	1_5	A	3	OBSERVATIONAL UNIT
78	8325064	Ames	SetF	F	STM	2	TRIAL SET
89	8325064	Ames	SetF	6_1	F	3	OBSERVATIONAL UNIT
910	8325064	Ames	SetF	6_2	F	3	OBSERVATIONAL UNIT
1011	8325064	Ames	SetF	6_3	F	3	OBSERVATIONAL UNIT
1112	8325064	Ames	SetG	G	STM	2	TRIAL SET
13	8325064	Ames	SetG	7_1	G	3	OBSERVATIONAL UNIT
14	8325064	Ames	SetG	7_2	G	3	OBSERVATIONAL UNIT
15	8325064	Ames	SetG	7_3	G	3	OBSERVATIONAL UNIT
16	8325064	Ames	SetG	R	STM	2	TRIAL SET
17	8325064	Ames	SetR	18_1	R	3	OBSERVATIONAL UNIT
18	8325064	Ames	SetR	18_2	R	3	OBSERVATIONAL UNIT
1819	8325064	Ames	SetR	18_3	R	3	OBSERVATIONAL UNIT

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