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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

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:	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 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).
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

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 Organization

Jira

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

Example Applicant, Inc.

9

123

TS

1

APREFID

Study Reference ID

NOT APPLICABLE

10

123

TS

1

TSTFNAM

Test Facility Name

Example Test Lab Name

11

123

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

12

123

TS

1

TFCNTRY

Test Facility Country

USA

13

123

TS

1

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

...

Dataset wrap

Name	gt

Rowcaps

Rows 1-3, 8:	Show percentage result values that apply to GTREFID=C0. REFID=C0, as shown in the RELREF dataset, relates this data to the trial set in the first row of table 1 in the sample report table for study 123.
Rows 4-7:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C0-Count1 through C0-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.
Rows 9-11, 16:	Show percentage result values that apply to GTREFID=C1250. REFID=C1250, as shown in the RELREF dataset, relates this data to the trial set in the second row of table 1 in the sample report table for study 123.
Rows 12-15:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C1250-Count1 through C1250-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.

Dataset2

TOBA-643

TOBA-756

Row	STUDYID	DOMAIN	GTSEQ	GTREFID	GTTESTCD	GTTEST	GTCELLEV	GTORRES	GTORRESU	GTCOLSRT	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC
1	123	GT	1	C0	RICC	1	123	GT	1	C0	RICC
Jira
showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	Relative Increase in Cell Count	154	0	%		0	0	%	2022-05-25
2	123	GT	2	C0	RCC	Relative Cell Count	154	0	%		0	0	%	2022-05-25
3	123	GT	3	C0	RPD	Relative Population Doubling	154	0	%		0	0	%	2022-05-25
4	123	GT	4	C0-Count1	MNCE	Micronucleated Cells	2205	15
Jira
showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key			15	15		2022-05-25
5	123	GT	5	C0-Count2	MNCE	Micronucleated Cells	2474	13			13	13		2022-05-25
6	123	GT	6	C0-Count3	MNCE	Micronucleated Cells	2758	17			17	17		2022-05-25
7	123	GT	7	C0-Count4	MNCE	Micronucleated Cells	2669	12			12	12		2022-05-25
8	123	GT	8	C0	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	MNCE	Micronucleated Cells	3266	20			20	20		2022-05-25
13	123	GT	5	C1250-Count2	MNCE	Micronucleated Cells	2190	17			17	17		2022-05-25
14	123	GT	6	C1250-Count3	MNCE	Micronucleated Cells	2758	13			13	13		2022-05-25
15	123	GT	7	C1250-Count4	MNCE	Micronucleated Cells	2714	21			21	21		2022-05-25
16	123	GT	8	C1250	MNCECE	Micronucleated Cells/Total Cells		0.66	%		0.66	0.66	%	2022-05-25

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