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title	Report Table for Example Study 8325064

This table shows the assay results for Study 8325064, Test Article TA1, and three strains of Salmonella (TA98, TA100, and TA1535) at varying concentrations. For ease of reference, each row has been labeled in the right hand margin with the sponsor applicant-defined trial set label (e.g., SetA). For brevity, the remaining tables (e.g., additional strains, samples prepared without metabolic activation, etc.) are not included.

Dataset wrap

Rowcaps

Rows 1-2:	Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study.
Row 8:	Shows that the sponsorapplicant's study reference ID is not applicable.
Rows 9-12:	Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The Study Director is associated with the Test Facility.
Rows 18-26:	Show that this example study includes two different species of bacteria and a total of five strains.
Rows 18-23:	Show that TSGRPID (TSGRPID = 2) has been used to link the information for one species (Salmonella) with four different strains that are tested in this example study.
Rows 24-26:	Show that TSGRPID (TSGRPID = 3) has been used to link the information for one species (Escherichia coli) with the strain that is tested in this example study.

Dataset2

Row

STUDYID

GNTXAID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1

8325064

Ames

TS

1

GLPTYP

Good Laboratory Practice Type

FDA

2

8325064

Ames

TS

2

GLPTYP

Good Laboratory Practice Type

OECD

3

8325064

Ames

TS

1

STSTDTC

Study Start Date

2015-07-29

4

8325064

Ames

TS

1

STITLE

Study Title

The Bacterial Reverse Mutation Test, Study 8325064-1

5

8325064

Ames

TS

1

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0

6

8325064

Ames

TS

1

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30

7

8325064

Ames

TS

1

SSPONSORSAPPLCNT

Sponsor Applicant Organization

Example Sponsor Applicant Inc.

8

8325064

Ames

TS

1

SPREFID

SponsorApplicant's Study Reference ID

NOT APPLICABLE

9

8325064

Ames

TS

1

TSTFNAM

Test Facility Name

Example Tox Lab Name

10

8325064

Ames

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

11

8325064

Ames

TS

1

TFCNTRY

Test Facility Country

USA

12

8325064

Ames

TS

1

STDIR

Study Director

Dr. R. Smith

13

8325064

Ames

TS

1

GLPFL

GLP Flag

N

14

8325064

Ames

TS

1

ASTD

Assay Standard

OECD TEST NO. 471

15

8325064

Ames

TS

1

ASTDV

Assay Standard Version

2020-06-29

16

8325064

Ames

TS

1

SSTYP

Study Type

GENOTOXICITY IN VITRO

17

8325064

Ames

TS

1

SSSTYP

Study Sub Type

BACTERIAL REVERSE MUTATION TEST

18

8325064

Ames

TS

1

2

SPECIES

Species

SALMONELLA TYPHIMURIUM

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-123

19

8325064

Ames

TS

1

2

STRAIN

Strain/Substrain

TA98

20

8325064

Ames

TS

1

2

STRAIN

Strain/Substrain

TA100

21

8325064

Ames

TS

1

2

STRAIN

Strain/Substrain

TA1535

22

8325064

Ames

TS

1

2

STRAIN

Strain/Substrain

TA1537

23

8325064

Ames

TS

1

2

CELLLN

Cell Line

24

8325064

Ames

TS

1

3

SPECIES

Species

Escherichia coli

25

8325064

Ames

TS

1

3

STRAIN

Strain/Substrain

WP2 uvrA pKM101

26

8325064

Ames

TS

1

3

CELLLN

Cell Line

...

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 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 16-23:	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.
Rows 25-32:	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.
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:	Shows a value for SPTOBID=CIG01a. SPTOBID is SponsorApplicant-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).
Row 13:	Shows a value for SPDEVID. SPDEVID is the Sponsor applicant-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).
Row 14:	Shows 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	In vitro Treatment Duration Minimum	71.5
3	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	3	TRTDTRG	In vitro Treatment Duration Target	72
4	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	4	TRTDMAX	In vitro Treatment Duration Maximum	72.5
5	8325064	Ames	TX	SetSTM	SALMONELLA TYPHIMURIUM	5	TRTDU	In vitro 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 Applicant-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 Applicant-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	PSETCD	Parent Set Code	SetSTM
16	8325064	Ames	TX	SetA	A-TA98-C0	15	STRAIN	Strain/Substrain	TA98
17	8325064	Ames	TX	SetA	A-TA98-C0	16	METACT	Metabolic Activation	NOT APPLICABLE
18	8325064	Ames	TX	SetA	A-TA98-C0	17	METACTFL	Y/N presence of metabolic activation	N
19	8325064	Ames	TX	SetA	A-TA98-C0	18	INTRVN	Name of the intervention article	TA1
20	8325064	Ames	TX	SetA	A-TA98-C0	19	ITVTYPE	Type of intervention article	Vehicle Control
21	8325064	Ames	TX	SetA	A-TA98-C0	20	ITVCONC	Concentration of intervention article	0
22	8325064	Ames	TX	SetA	A-TA98-C0	21	ITVCONCU	Concentration Unit	ug/plate
23	8325064	Ames	TX	SetA	A-TA98-C0	22	TRTV	Treatment Vehicle	DMSO
24	8325064	Ames	TX	SetF	F-TA98-C500		PSETCD	Parent Set Code	SetSTM
25	8325064	Ames	TX	SetF	F-TA98-C500	23	STRAIN	Strain/Substrain	TA98
26	8325064	Ames	TX	SetF	F-TA98-C500	24	METACT	Metabolic Activation	NOT APPLICABLE
27	8325064	Ames	TX	SetF	F-TA98-C500	25	METACTFL	Y/N presence of metabolic activation	N
28	8325064	Ames	TX	SetF	F-TA98-C500	26	INTRVN	Name of the intervention article	TA1
29	8325064	Ames	TX	SetF	F-TA98-C500	27	ITVTYPE	Type of intervention article	Product
30	8325064	Ames	TX	SetF	F-TA98-C500	28	ITVCONC	Concentration of intervention article	500
31	8325064	Ames	TX	SetF	F-TA98-C500	29	ITVCONCU	Concentration Unit	ug/plate
32	8325064	Ames	TX	SetF	F-TA98-C500	30	TRTV	Treatment Vehicle	DMSO
33	8325064	Ames	TX	SetG	G-TA98-C1600	31	PSETCD	Parent Set Code	SetSTM
34	8325064	Ames	TX	SetG	G-TA98-C1600	31	STRAIN	Strain/Substrain	TA98
35	8325064	Ames	TX	SetG	G-TA98-C1600	32	METACT	Metabolic Activation	NOT APPLICABLE
36	8325064	Ames	TX	SetG	G-TA98-C1600	33	METACTFL	Y/N presence of metabolic activation	N
37	8325064	Ames	TX	SetG	G-TA98-C1600	34	INTRVN	Name of the intervention article	TA1
38	8325064	Ames	TX	SetG	G-TA98-C1600	35	ITVTYPE	Type of intervention article	Product
39	8325064	Ames	TX	SetG	G-TA98-C1600	36	ITVCONC	Concentration of intervention article	1600
40	8325064	Ames	TX	SetG	G-TA98-C1600	37	ITVCONCU	Concentration Unit	ug/plate
41	8325064	Ames	TX	SetG	G-TA98-C1600	38	TRTV	Treatment Vehicle	DMSO
42	8325064	Ames	TX	SetR	R-TA100-C2	39	PSETCD	Parent Set Code	SetSTM
43	8325064	Ames	TX	SetR	R-TA100-C2	39	STRAIN	Strain/Substrain	TA100
44	8325064	Ames	TX	SetR	R-TA100-C2	40	METACT	Metabolic Activation	NOT APPLICABLE
45	8325064	Ames	TX	SetR	R-TA100-C2	41	METACTFL	Y/N presence of metabolic activation	N
46	8325064	Ames	TX	SetR	R-TA100-C2	42	INTRVN	name of the intervention article	NaN3
47	8325064	Ames	TX	SetR	R-TA100-C2	43	ITVTYPE	type of intervention article	Positive Control
48	8325064	Ames	TX	SetR	R-TA100-C2	44	ITVCONC	Concentration of intervention article	2
49	8325064	Ames	TX	SetR	R-TA100-C2	45	ITVCONCU	Concentration Unit	ug/plate
50	8325064	Ames	TX	SetR	R-TA100-C2	46	TRTV	Treatment Vehicle	DMSO

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