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This example shows a sample report table, trial design, and results dataset for Study #123 study 123 for the determination of the in vitro genotoxicity potential of tobacco products using the in vitro Micronucleus Assay

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-332

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-135

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-127

Expand

title	Sample Report Table for Study 123

Image Removed

micronucleus assay.

Expand

title	Sample Report Table for Study 123

Image Added

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

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 applicant'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 study director is associated with the Test Facility.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
Dataset2
	Row	STUDYID	GNTXAID	DOMAIN

Row	STUDYID	DOMAIN

TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123

NRU

TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123

NRU

TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123

NRU

STSTDTCStudy Start Date2022-

	GLPFL	GLP Flag	Y
4	123	TS	1		STSTDTC	Study Start Date	2022-05-25


5	123

NRU

STITLE

Study Title

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


6	123

NRU

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0


7	123

NRU

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30


8	123

NRU

SAPPLCNT

APPLCNT

Applicant

Organization

Jira

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

Example Applicant, Inc.

Example Applicant, Inc.
9	123	TS	1		APREFID	Study Reference

8123NRUTS1SPREFID Study Reference

NOT APPLICABLE

123

NRU

TSTFNAM

Test Facility Name

Example Test Lab Name


11	123

NRU

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000


12	123

NRU

TFCNTRY

Test Facility Country

USA


13	123

NRU

STDIR

Study Director

Dr. R. Smith


14	123

NRU

GLPFLOECD

GLP FlagY14123NRUTS1ASTDAssay Standard

TSTGDNAM

Testing Guideline Name

GUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15	123

	TS	1	2	TSTGDORG	Testing Guideline Organization	OECD
16	123

NRU

ASTDV

TSTGDVER

Testing Guideline

Assay Standard

Version

29-July-2016


17	123

NRU

SSTYP

Study Type

GENOTOXICITY IN VITRO


18	123

NRU

SSSTYPStudy Sub TypeMICRONUCLEUS TEST

	GNTXAID	Genetic Toxicology Assay Identifier	MNvit
19

123

NRU

SPECIES

Species

HUMAN


20	123

NRU

CELLLN

Cell Line

TK6 LYMPHOBLASTOID

This example trial set dataset, tx.xpt, Trial Sets dataset shows information about the test conditions for set A1 and A2 in this example study, 123. Set Sets A1 and A2 can be seen in the first and second rows respectively of the sample report Table 1 in the Sample Report table for Study 123 (above). For brevity, the trial sets dataset, tx.xpt, TX dataset and the findings dataset, gt.xpt (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.

Dataset wrap

Name	tx

Show trial set parameters and trial set values that comprise the test conditions for trial set A1. Set A1 is the

Rowcaps

Rows 1-

23:

Show

the experimental

trial set parameters

that are common for Table 1 of Study 123.

Rows 18, 25:

Show that set 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:

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

study 123.

Rows

24-

46:	Show trial set parameters and

trial set

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.

"ST+S9_C1250".

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

Dataset2
Dataset2

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	MNvit	TX	A	ST+S9	1	METACT	Metabolic Activation	+S9
2	123	MNvit	TX	A	ST+S9	2	METACTFL	Y/N presence of metabolic activation	Y
3	123	MNvit	TX	A	ST+S9	3	TRTDMIN	In vitro Treatment Duration Minimum	3
4	123	MNvit	TX	A	ST+S9	4	TRTDTRG	In vitro Treatment Duration Target	3.5
5	123	MNvit	TX	A	ST+S9	5	TRTDMAX	In vitro Treatment Duration Maximum	4
6	123	MNvit	TX	A	ST+S9	6	TRTDU	In vitro Treatment Duration Unit	HOURS
7	123	MNvit	TX	A	ST+S9	7	RCVDMIN	Recovery Duration Minimum	23.5
8	123	MNvit	TX	A	ST+S9	8	RCVDTRG	Recovery Duration Target	24
9	123	MNvit	TX	A	ST+S9	9	RCVDMAX	Recovery Duration Maximum	24.5
10	123	MNvit	TX	A	ST+S9	10	RCVDU	Recovery Duration Unit	HOURS
11	123	MNvit	TX	A	ST+S9	11	INCBTMP	Incubation Temperature	37
12	123	MNvit	TX	A	ST+S9	12	INCBTMPU	Incubation Temperature Unit	C
13	123	MNvit	TX	A	ST+S9	13	HUMID	Atmospheric Relative Humidity Percent	50
14	123	MNvit	TX	A	ST+S9	14	ATMCO2	Atmospheric CO2 Percent	5
15	123	MNvit	TX	A	ST+S9	15	SPTOBID	Applicant-defined tobacco identifier	CIG01a
16	123	MNvit	TX	A	ST+S9	16	EXPTYP	Exposure Type	Submerged
17	123	MNvit	TX	A	ST+S9	17	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	MNvit	TX	A1	ST+S9_C0	1	PSETCD	Parent Set Code	A
19	123	MNvit	TX	A1	ST+S9_CO	2	INTRVN	Name of the Intervention Article	Tobacco ProdA
20	123	MNvit	TX	A1	ST+S9_C0	3	ITVTYPE	type of intervention article	Negative Control
21	123	MNvit	TX	A1	ST+S9_C0	4	ITVCONC	Concentration of intervention article	0
22	123	MNvit	TX	A1	ST+S9_C0	5	ITVCONCU	Concentration Unit	ug/ml
23	123	MNvit	TX	A1	ST+S9_C0	6	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
24	123	MNvit	TX	A1	ST+S9_C0	7	DUREFID	Smoke Regimen	Medium Intensity Regimen
25	123	MNvit

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	123

ST+S9_C1250

PSETCD

Parent Set Code

A26123

SAMTYP	Sample Type	Total Particulate Matter in DMSO
41	123

MNvit

ST+S9_C1250

INTRVN

ITVNAM

Name of the

Intervention Article Name

Tobacco ProdA

123

MNvit

ST+S9_C1250

ITVTYPE

type of intervention article

Intervention Article Type

Product

123

MNvit

ST+S9_C1250

ITVCONC

Intervention Article Concentration

of intervention article

1250

123

MNvit

ST+S9_C1250

ITVCONCU

Intervention Article Concentration Unit

ug/ml

123

MNvit

ST+S9_C1250

SPDEVID

Applicant-defined

device identifier

Device Identifier

PUFFMASTER2023

123

MNvit

ST+S9_C1250

DUREFID

SMKRGM

Smoke

Smoking Regimen

High Intensity Regimen

HIGH INTENSITY REGIMEN

Dataset wrap

Name	relref

Rowcaps

Row 1:	Shows the value of REFID=C0. This REFID refers to the trial set with a SETCD of '"A1'", as defined in the trial set dataset, tx.xpt. TX dataset. LEVEL=1 and LVLDESC='"EXPERIMENTAL UNIT/TRIAL SET' " indicates this identifier is referring to both the experimental unit , and the unit to which the treatment is applied, and to the entire trial set.
Rows 2-5:	Show the values of four 4 observational units (C0_Count1 through C0_Count4) that are within the parent experimental unit, REFID=C0, and in . In this example assay, these observational units are also all within the same trial set, as defined in the trial set TX dataset, tx.xpt.
Row 6:	Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of '"A2'", as defined in the trial set dataset, tx.xpt. TX dataset. LEVEL=1 and LVLDESC='"EXPERIMENTAL UNIT/TRIAL SET' " indicates this identifier is referring to both the experimental unit , and the unit to which the treatment is applied, and to the entire trial set.
Rows 7-10:	Show the values of four 4 observational units (C1250_Count1 through C1250_Count4) that are within the parent experimental unit, REFID= C0, and in C1250. In this example assay, these observational units are also all within the same trial set, as defined in the trial set dataset, tx.xpt TX dataset.

Dataset2

tableid	relref

Row	STUDYID

GNTXAID

	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123

MNvit

	A1	C0		1	EXPERIMENTAL UNIT/TRIAL SET
2	123

MNvit

	A1	C0-Count1	C0	2	OBSERVATIONAL UNIT
3	123

MNvit

A1	C0-Count2	C0	2	OBSERVATIONAL UNIT
4	123

MNvit

	A1	C0-Count3	C0	2	OBSERVATIONAL UNIT
5	123

MNvit

A1	C0-Count4	C0	2	OBSERVATIONAL UNIT
6	123

MNvit

A2	C1250		1	EXPERIMENTAL UNIT/TRIAL SET
7	123

MNvit

	A2	C1250-Count1	C1250	2	OBSERVATIONAL UNIT
8	123

MNvit

A2	C1250-Count2	C1250	2	OBSERVATIONAL UNIT
9	123

MNvit

	A2	C1250-Count3	C1250	2	OBSERVATIONAL UNIT
10	123

MNvit

C1250-Count4

C1250

OBSERVATIONAL UNIT

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

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

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

	RPD	Relative Population Doubling	134	7.9	%		7.9	7.9	%	2022-05-25
12	123

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