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This example shows a sample report table, trial design, and results dataset for study 123 for the determination of the in vitro genotoxicity potential of tobacco products using the in vitro micronucleus assay. JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-642

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title	Sample Report Table for Study 123

...

Dataset wrap

...

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-456

Show 2 records for TSPARMCD =

Rowcaps

Rows 1-2:

Show 2 records for TSPARMCD =

Dataset wrap

Rows 1-2:

"GLPTYP", using TSSEQ to indicate multiple records,

Image RemovedTOBA-366 UNDER GGG REVIEW

since both GLP types apply for

this

this example study.
Row 3:	Shows that this study was conducted as a GLP study.
Rows 4-5:

Shows

Show the study start date and study title.
Rows 6-7:	Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study.
Row 8:	Shows the applicant's organization.
Row 9:	Shows that the applicant'

s study

s study reference ID is not applicable.
Rows 10-13:	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 14-16:	Show that TSGRPID (TSGRPID=

4

2) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).

Image RemovedTOBA-56 - Assay Standard DONE

Row 17

:	Shows the study type for this study.
Row 18:	Shows that this study includes a Mammalian Cell Micronucleus Assay.
Rows 19-

27

20:

Show that

TSGRPID (TSGRPID = 2) has been used to link

the

information for 1 species (salmonella) with the 4 different strains and cell lines that are tested in this study.

species is human and the cell line is TK6 lymphoblastoid in this study.

Dataset2

Row	STUDYID	DOMAIN	TSSEQ	TSPARMCD	TSPARM	TSVAL
1	123	TS	1	GLPTYP	Good Laboratory Practice Type	FDA
2	123	TS	2	GLPTYP	Good Laboratory Practice Type	OECD
3	123	TS	1	GLPFL	GLP Flag	Y
4	123	TS	1	STSTDTC	Study Start Date	2022-05-25
5	123	TS	1	STITLE	Study Title	Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay
6	123	TS	1	SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7	123	TS	1	SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
8	123	TS	1	APPLCNT	Applicant	Example Applicant, Inc.
9

Rows 28-30:

Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain and cell line that is tested in this study. Image RemovedTOBA-665 UNDER G

Rowcaps

Rows 1-2:

Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this example study.

Row 3:

Shows that this study was conducted as a GLP study.

Rows 4-5:

Shows the study start date and study title.

Rows 6-7:

Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study.

Row 8:

Shows the applicant's organization.

Row 9:

Shows that the applicant's study reference ID is not applicable.

Rows 10-13:

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 14-16:

Show that TSGRPID (TSGRPID=2) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-56

Row 17:

Shows the study type for this study.

Row 18:

Shows that this study includes a Mammalian Cell Micronucleus Assay.

Rows 19-20:

Show that the species is human and the cell line is TK6 lymphoblastoid in this study.

Dataset2

Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1

123

TS

1

GLPTYP

Good Laboratory Practice Type

FDA

2

123

TS

2

GLPTYP

Good Laboratory Practice Type

OECD

3

123

TS

1

APREFID

Study Reference ID

NOT APPLICABLE

10

GLPFL

GLP Flag

Y

4

123

TS

1

STSTDTC1

Study Start Date

2022-05-25

TSTFNAM

Test Facility Name

Example Test Lab Name

11

5

123

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

12

STITLE

Study Title

Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay

6

123

TS

1

TFCNTRY

Test Facility Country

USA

13

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0

7

123

TS

1

SNDCTVER

SEND Controlled Terminology Version

1

STDIR

Study Director

Dr. R. Smith

14

SEND Terminology 2021-09-30

8

123

TS

1

2

TSTGDNAM

Testing Guideline Name

GUIDELINE FOR THE TESTING OF CHEMICALS No. 487

15

123

TS

1

2

TSTGDORG

Testing Guideline Organization

OECD

16

APPLCNT

Applicant Organization

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-356

Example Applicant, Inc.

9

123

TS

1

2

TSTGDVER

Testing Guideline Version

29-July-2016

17

APREFID

Study Reference ID

NOT APPLICABLE

10

123

TS

11

SSTYP

TSTFNAM

Test Facility Name

Example Test Lab Name

Study Type

GENOTOXICITY IN VITRO

18

11

123

TS

1

TSTFLOC

Test Facility Location

GNTXAID

Genetic Toxicology Assay Identifier

MNvit

19

10 Somewhere Street, Montgomery, AL 10000

12

123

TS

11

SPECIES

TFCNTRYSpecies

Test Facility Country

USA

HUMAN

2013

123

TS

11

CELLLN

STDIR

Study Director

Dr. R. Smith

14

123

TS

1

2

TSTGDNAM

Testing Guideline Name

GUIDELINE FOR THE TESTING OF CHEMICALS No. 487

15

123

TS

1

2

TSTGDORG

Testing Guideline Organization

OECD

16

123

TS

1

2

TSTGDVER

Testing Guideline Version

29-July-2016

17

123

TS

1

SSTYP

Study Type

GENOTOXICITY IN VITRO

18

123

TS

1

GNTXAID

Genetic Toxicology Assay Identifier

MNvit

19

123

TS

1

SPECIES

Species

HUMAN

20

123

TS

1

CELLLN

Cell Line

TK6 LYMPHOBLASTOID

This example Trial Sets dataset shows information about the test conditions for set A1 and A2 in this example study. Sets A1 and A2 can be seen in the first and second rows respectively of the sample report Table 1 (above). For brevity, the TX dataset and the findings (GT) dataset do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets.

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-457

Cell Line

TK6 LYMPHOBLASTOID

This example Trial Sets dataset shows information about the test conditions for set A1 and A2 in this example study. Sets A1 and A2 can be seen in the first and second rows respectively of the sample report Table 1 (above). For brevity, the TX dataset and the findings (GT) dataset do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets.

26

Dataset wrap

Name	tx

Rowcaps

Rows 1-23:

Show trial set parameters and values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short-term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0".

Set A1 is associated with the first row in the sample report table for study 123.

Rows 24-46:

Show trial set parameters and values that comprise the test conditions for trial set A2. Set A2 is the data for the short-term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250".

Set A2 is associated with the second row in the sample report table for study 123.

Dataset2

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	TX	A1	ST+S9_C0	1	MTACTIND	Metabolic Activating Agent Name	+S9
2	123	TX	A1	ST+S9_C0	2	METACTFL	Presence of Metabolic Activation Flag	Y
3	123	TX	A1	ST+S9_C0	3	IVTDMIN	In vitro Treatment Duration Minimum	3
4	123	TX	A1	ST+S9_C0	4	IVTDTRG	In vitro Treatment Duration Target	3.5
5	123	TX	A1	ST+S9_C0	5	IVTDMAX	In vitro Treatment Duration Maximum	4
6	123	TX	A1	ST+S9_C0	6	IVTDU	In vitro Treatment Duration Unit	HOURS
7	123	TX	A1	ST+S9_C0	7	RCVDMIN	Recovery Duration Minimum	23.5
8	123	TX	A1	ST+S9_C0	8	RCVDTRG	Recovery Duration Target	24
9	123	TX	A1	ST+S9_C0	9	RCVDMAX	Recovery Duration Maximum	24.5
10	123	TX	A1	ST+S9_C0	10	RCVDU	Recovery Duration Unit	HOURS
11	123	TX	A1	ST+S9_C0	11	INCBTMP	Incubation Temperature	37
12	123	TX	A1	ST+S9_C0	12	INCBTMPU	Incubation Temperature Unit	C
13	123	TX	A1	ST+S9_C0	13	ATMRHP	Atmospheric Relative Humidity Percent	50
14	123	TX	A1	ST+S9_C0	14	ATMCO2P	Atmospheric CO2 Percent	5
15	123	TX	A1	ST+S9_C0	15	SPTOBID	Applicant-defined tobacco identifier	CIG01a
16	123	TX	A1	ST+S9_C0	16	EXPTYP	Exposure Type	Submerged
17	123	TX	A1	ST+S9_C0	17	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	TX	A1	ST+S9_CO	18	ITVNAM	Intervention Article Name	Tobacco ProdA
19	123	TX	A1	ST+S9_C0	19	ITVTYPE	Intervention Article Type	Negative Control
20	123	TX	A1	ST+S9_C0	20	ITVCONC	Intervention Article Concentration	0
21	123	TX	A1	ST+S9_C0	21	ITVCONCU	Intervention Article Concentration Unit	ug/ml
22	123	TX	A1	ST+S9_C0	22	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
23	123	TX	A1	ST+S9_C0	23	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
24	123	TX	A2	ST+S9_C1250	24	MTACTIND	Metabolic Activating Agent Name	+S9
25	123	TX	A2	ST+S9_C1250	25	METACTFL	Presence of Metabolic Activation Flag	Y
26	123	TX	A2	ST+S9_C1250	26	IVTDMIN	In vitro Treatment Duration Minimum	3
27	123	TX	A2	ST+S9_C1250	27	IVTDTRG	In vitro Treatment Duration Target	3.5
28	123	TX	A2	ST+S9_C1250	28	IVTDMAX	In vitro Treatment Duration Maximum	4
29	123	TX	A2	ST+S9_C1250	29	IVTDU	In vitro Treatment Duration Unit	HOURS
30	123	TX	A2	ST+S9_C1250	30	RCVDMIN	Recovery Duration Minimum	23.5
31	123	TX	A2	ST+S9_C1250	31	RCVDTRG	Recovery Duration Target	24
32	123	TX	A2	ST+S9_C1250	32	RCVDMAX	Recovery Duration Maximum	24.5
33	123	TX	A2	ST+S9_C1250	33	RCVDU	Recovery Duration Unit	HOURS
34	123	TX	A2	ST+S9_C1250	34	INCBTMP	Incubation Temperature	37
35	123	TX	A2	ST+S9_C1250	35	INCBTMPU	Incubation Temperature Unit	C
36	123	TX	A2	ST+S9_C1250	36	ATMRHP	Atmospheric Relative Humidity Percent	50
37	123	TX	A2	ST+S9_C1250	37	ATMCO2P	Atmospheric CO2 Percent	5
38	123	TX	A2	ST+S9_C1250	38	SPTOBID	Applicant-defined tobacco identifier	CIG01a
39	123	TX	A2	ST+S9_C1250	39	EXPTYP	Exposure Type	Submerged
40

Dataset wrap

Name	tx

25

Rowcaps
Rows 1-17:	Show the experimental parameters that are common for table 1 of study 123.
Rows 18, 25:	Show that sets A1 and A2 each have a parent set code of A. As a child of set A, each of these sets inherit the test conditions of set A.
Rows 18-24:	Show trial set parameters and values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short-term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0". Set A1 is associated with the first row in the sample report table for study 123.
Rows 25-31:	Show trial set parameters and values that comprise the test conditions for trial set A2. Set A2 is the data for the short-term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250". Set A2 is associated with the second row in the sample report table for study 123.
Dataset2

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	TX	A	ST+S9	1	METACTIND	Metabolic Activating Agent Name	+S9
2	123	TX	A	ST+S9	2	METACTFL	Presence of Metabolic Activation Flag	Y
3	123	TX	A	ST+S9	3	IVTDMIN	In vitro Treatment Duration Minimum	3
4	123	TX	A	ST+S9	4	IVTDTRG	In vitro Treatment Duration Target	3.5
5	123	TX	A	ST+S9	5	IVTDMAX	In vitro Treatment Duration Maximum	4
6	123	TX	A	ST+S9	6	IVTDU	In vitro Treatment Duration Unit	HOURS
7	123	TX	A	ST+S9	7	RCVDMIN	Recovery Duration Minimum	23.5
8	123	TX	A	ST+S9	8	RCVDTRG	Recovery Duration Target	24
9	123	TX	A	ST+S9	9	RCVDMAX	Recovery Duration Maximum	24.5
10	123	TX	A	ST+S9	10	RCVDU	Recovery Duration Unit	HOURS
11	123	TX	A	ST+S9	11	INCBTMP	Incubation Temperature	37
12	123	TX	A	ST+S9	12	INCBTMPU	Incubation Temperature Unit	C
13	123	TX	A	ST+S9	13	ATMRHP	Atmospheric Relative Humidity Percent	50
14	123	TX	A	ST+S9	14	ATMCO2P	Atmospheric CO2 Percent	5
15	123	TX	A	ST+S9	15	SPTOBID	Applicant-defined tobacco identifier	CIG01a
16	123	TX	A	ST+S9	16	EXPTYP	Exposure Type	Submerged
17	123	TX	A	ST+S9	17	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	TX	A1	ST+S9_C0	1	PSETCD	Parent Set Code	A
19	123	TX	A1	ST+S9_CO	2	ITVNAM	Intervention Article Name	Tobacco ProdA
20	123	TX	A1	ST+S9_C0	3	ITVTYPE	Intervention Article Type	Negative Control
21	123	TX	A1	ST+S9_C0	4	ITVCONC	Intervention Article Concentration	0
22	123	TX	A1	ST+S9_C0	5	ITVCONCU	Intervention Article Concentration Unit	ug/ml
23	123	TX	A1	ST+S9_C0	6	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
24	123	TX	A1	ST+S9_C0	7	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN

123

TX

A2

ST+S9_C1250

1

40

PSETCD

Parent Set Code

A

SAMTYP	Sample Type	Total Particulate Matter in DMSO
41	123	TX	A2	ST+S9_C1250

2

41

ITVNAM

Intervention Article Name

Tobacco ProdA

27

42

123

TX

A2

ST+S9_C1250

3

42

ITVTYPE

Intervention Article Type

Product

28

43

123

TX

A2

ST+S9_C1250

4

43

ITVCONC

Intervention Article Concentration

1250

29

44

123

TX

A2

ST+S9_C1250

5

44

ITVCONCU

Intervention Article Concentration Unit

ug/ml

30

45

123

TX

A2

ST+S9_C1250

6

45

SPDEVID

Applicant-defined Device Identifier

PUFFMASTER2023

31

46

123

TX

A2

ST+S9_C1250

7

46

SMKRGM

Smoking Regimen

HIGH INTENSITY REGIMEN

RPD	Relative Population Doubling	154	0	%		0	0	%	2022-05-25
4	123	GT	4	C0-Count1

	MNCECE	Micronucleated Cells/Total Cells		0.57	%		0.57	0.57	%	2022-05-25
9	123	GT	1	C1250

	RICC	Relative Increase in Cell Count	134	15.7	%		15.7	15.7	%	2022-05-25
10	123	GT	2	C1250

	RCC	Relative Cell Count	134	13.0	%		13.0	13.0	%	2022-05-25
11	123	GT	3	C1250

	RPD	Relative Population Doubling	134	7.9	%		7.9	7.9	%	2022-05-25
12	123	GT	4	C1250-Count1

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