Page History

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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 sponsor'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 18-24:	Show that this example study includes two different species of bacteria and a total of five strains.
Rows 18-22:	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 23-24:	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

SSPONSOR

Sponsor Organization

Example Sponsor Inc.

8

8325064

Ames

TS

1

SPREFID

Sponsor'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 SALMONELLA

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

3

SPECIES

Species

Escherichia coli

24

8325064

Ames

TS

1

3

STRAIN

Strain/Substrain

WP2 uvrA pKM101

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Dataset wrap

Name	tx

Rowcaps

Rows 1-22:	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 23-44:	Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the vehicle control (i.e., Strain of TA100, positive control with a concentration value of 2). SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
Rows 13, 35:	Show 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 2.8.8.6 Tobacco Product Identifiers and Descriptors (TO).
Rows 21, 43:	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, 44:	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	SetA	A-TA98-C0	1	SPECIES	SpeciesSalmonella	typhimuriumSALMONELLA TYPHIMURIUM
2	8325064	Ames	TX	SetA	A-TA98-C0	2	STRAIN	Strain/Substrain	TA98
3	8325064	Ames	TX	SetA	A-TA98-C0	3	METACT	Metabolic Activation	NOT APPLICABLE
4	8325064	Ames	TX	SetA	A-TA98-C0	4	METACTFL	Y/N presence of metabolic activation	N
5	8325064	Ames	TX	SetA	A-TA98-C0	5	TRTDMIN	Treatment Duration Minimum	71.5
6	8325064	Ames	TX	SetA	A-TA98-C0	6	TRTDTRG	Treatment Duration Target	72
7	8325064	Ames	TX	SetA	A-TA98-C0	7	TRTDMAX	Treatment Duration Maximum	72.5
8	8325064	Ames	TX	SetA	A-TA98-C0	8	TRTDU	Treatment Duration Unit	HOURS
9	8325064	Ames	TX	SetA	A-TA98-C0	9	INCBTMP	Incubation Temperature	37
10	8325064	Ames	TX	SetA	A-TA98-C0	10	INCBTMPU	Incubation Temperature Unit	C
11	8325064	Ames	TX	SetA	A-TA98-C0	11	HUMID	Atmospheric Relative Humidity Percent	50
12	8325064	Ames	TX	SetA	A-TA98-C0	12	ATMCO2	Atmospheric CO2 Percent	5
13	8325064	Ames	TX	SetA	A-TA98-C0	13	SPTOBID	Sponsor defined tobacco identifier	CIG01a
14	8325064	Ames	TX	SetA	A-TA98-C0	14	EXPTYP	Exposure Type	Submerged
15	8325064	Ames	TX	SetA	A-TA98-C0	15	SAMTYP	Sample Type	Total Particulate Matter in PBS
16	8325064	Ames	TX	SetA	A-TA98-C0	16	INTRVN	Name of the intervention article	TA1
17	8325064	Ames	TX	SetA	A-TA98-C0	17	ITVTYPE	Type of intervention article	Vehicle Control
18	8325064	Ames	TX	SetA	A-TA98-C0	18	ITVCONC	Concentration of intervention article	0
19	8325064	Ames	TX	SetA	A-TA98-C0	19	ITVCONCU	Concentration Unit	ug/plate
20	8325064	Ames	TX	SetA	A-TA98-C0	20	TRTV	Treatment Vehicle	DMSO
21	8325064	Ames	TX	SetA	A-TA98-C0	21	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
22	8325064	Ames	TX	SetA	A-TA98-C0	22	DUREFID	Smoke Regimen	NON-INTENSE REGIMEN
23	8325064	Ames	TX	SetR	R-TA100-C2	1	SPECIES	Species	Salmonella typhimurium
24	8325064	Ames	TX	SetR	R-TA100-C2	2	STRAIN	Strain/Substrain	TA100
25	8325064	Ames	TX	SetR	R-TA100-C2	3	METACT	Metabolic Activation	NOT APPLICABLE
26	8325064	Ames	TX	SetR	R-TA100-C2	4	METACTFL	Y/N presence of metabolic activation	N
27	8325064	Ames	TX	SetR	R-TA100-C2	5	TRTDMIN	Treatment Duration Minimum	71.5
28	8325064	Ames	TX	SetR	R-TA100-C2	6	TRTDTRG	Treatment Duration Target	72
29	8325064	Ames	TX	SetR	R-TA100-C2	7	TRTDMAX	Treatment Duration Maximum	72.5
30	8325064	Ames	TX	SetR	R-TA100-C2	8	TRTDU	Treatment Duration Unit	HOURS
31	8325064	Ames	TX	SetR	R-TA100-C2	9	INCBTMP	Incubation Temperature	37
32	8325064	Ames	TX	SetR	R-TA100-C2	10	INCBTMPU	Incubation Temperature Unit	C
33	8325064	Ames	TX	SetR	R-TA100-C2	11	HUMID	Atmospheric Relative Humidity Percent	50
34	8325064	Ames	TX	SetR	R-TA100-C2	12	ATMCO2	Atmospheric CO2 Percent	5
35	8325064	Ames	TX	SetR	R-TA100-C2	13	SPTOBID	Sponsor defined tobacco identifier	CIG01a
36	8325064	Ames	TX	SetR	R-TA100-C2	14	EXPTYP	Exposure Type	Submerged
37	8325064	Ames	TX	SetR	R-TA100-C2	15	SAMTYP	Sample Type	Total Particulate Matter in PBS
38	8325064	Ames	TX	SetR	R-TA100-C2	16	INTRVN	name of the intervention article	TA1
39	8325064	Ames	TX	SetR	R-TA100-C2	17	ITVTYPE	type of intervention article	Positive Control
40	8325064	Ames	TX	SetR	R-TA100-C2	18	ITVCONC	Concentration of intervention article	2
41	8325064	Ames	TX	SetR	R-TA100-C2	19	ITVCONCU	Concentration Unit	ug/plate
42	8325064	Ames	TX	SetR	R-TA100-C2	20	TRTV	Treatment Vehicle	DMSO
43	8325064	Ames	TX	SetR	R-TA100-C2	21	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
44	8325064	Ames	TX	SetR	R-TA100-C2	22	DUREFID	Smoke Regimen	NON-INTENSE REGIMEN

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