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

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title	Sample Report Table for Study 123

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.

Dataset2

Row	STUDYID	ASSAYID	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	TS	1		STSTDTC	Study Start Date	2022-05-25
4	123	NRU	TS	1		STITLE	Study Title	Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay
5	123	NRU	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6	123	NRU	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
7	123	NRU	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
8	123	NRU	TS	1		SPREFID	Sponsor Study Reference ID		NOT APPLICABLE
9	123	NRU	TS	1	1	TSTFNAM	Test Facility Name	Example Test Lab Name
10	123	NRU	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
11	123	NRU	TS	1	1	TFCNTRY	Test Facility Country	USA
12	123	NRU	TS	1	1	STDIR	Study Director	Dr. R. Smith
13	123	NRU	TS	1		GLPFL	GLP Flag	Y
14	123	NRU	TS	1		ASTD	Assay Standard	NIH Publication OECD GUIDELINE FOR THE TESTING OF CHEMICALS No. 07-4519487
15	123	NRU	TS	1		ASTDV	Assay Standard Version	200629-July-112016
16	123	NRU	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
17	123	NRU	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red UptakeMICRONUCLEUS TEST
18	123	NRU	TS	1		SPECIES	Species	HamsterHUMAN
19	123	NRU	TS	1		TESTSYS	Test System	CHO TK6 LYMPHOBLASTOID

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

Rowcaps

Rows 1-23:

Show trial set parameters and trial set 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 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.

Dataset2

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	MNvit	TX	A1	ST+S9_C0	2	METACT	Metabolic Activation	+S9
2	123	MNvit	TX	A1	ST+S9_C0	3	METACTFL	Y/N presence of metabolic activation	Y
3	123	MNvit	TX	A1	ST+S9_C0	4	TRTDMIN	Treatment Duration Minimum	3
4	123	MNvit	TX	A1	ST+S9_C0	5	TRTDTRG	Treatment Duration Target	3.5
5	123	MNvit	TX	A1	ST+S9_C0	6	TRTDMAX	Treatment Duration Maximum	4
6	123	MNvit	TX	A1	ST+S9_C0	7	TRTDU	Treatment Duration Unit	HOURS
7	123	MNvit	TX	A1	ST+S9_C0	8	RCVDMIN	Recovery Duration Minimum	23.5
8	123	MNvit	TX	A1	ST+S9_C0	9	RCVDTRG	Recovery Duration Target	24
9	123	MNvit	TX	A1	ST+S9_C0	10	RCVDMAX	Recovery Duration Maximum	24.5
10	123	MNvit	TX	A1	ST+S9_C0	11	RCVDU	Recovery Duration Unit	HOURS
11	123	MNvit	TX	A1	ST+S9_C0	12	INCBTMP	Incubation Temperature	37
12	123	MNvit	TX	A1	ST+S9_C0	13	INCBTMPU	Incubation Temperature Unit	C
13	123	MNvit	TX	A1	ST+S9_C0	14	HUMID	Atmospheric Relative Humidity Percent	50
14	123	MNvit	TX	A1	ST+S9_C0	15	ATMCO2	Atmospheric CO2 Percent	5
15	123	MNvit	TX	A1	ST+S9_C0	16	SPTOBID	Sponsor defined tobacco identifier	CIG01a
16	123	MNvit	TX	A1	ST+S9_C0	17	EXPTYP	Exposure Type	Submerged
17	123	MNvit	TX	A1	ST+S9_C0	18	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	MNvit	TX	A1	ST+S9_C0	19	INTRVN	Name of the Intervention Article	Tobacco ProdA
19	123	MNvit	TX	A1	ST+S9_C0	20	ITVTYPE	type of intervention article	Negative Control
20	123	MNvit	TX	A1	ST+S9_C0	21	ITVCONC	Concentration of intervention article	0
21	123	MNvit	TX	A1	ST+S9_C0	22	ITVCONCU	Concentration Unit	ug/ml
22	123	MNvit	TX	A1	ST+S9_C0	23	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
23	123	MNvit	TX	A1	ST+S9_C0	24	DUREFID	Smoke Regimen	Medium Intensity Regimen
24	123	MNvit	TX	A2	ST+S9_C1250	2	METACT	Metabolic Activation	+S9
25	123	MNvit	TX	A2	ST+S9_C1250	3	METACTFL	Y/N presence of metabolic activation	Y
26	123	MNvit	TX	A2	ST+S9_C1250	4	TRTDMIN	Treatment Duration Minimum	3
27	123	MNvit	TX	A2	ST+S9_C1250	5	TRTDTRG	Treatment Duration Target	3.5
28	123	MNvit	TX	A2	ST+S9_C1250	6	TRTDMAX	Treatment Duration Maximum	4
29	123	MNvit	TX	A2	ST+S9_C1250	7	TRTDU	Treatment Duration Unit	HOURS
30	123	MNvit	TX	A2	ST+S9_C1250	8	RCVDMIN	Recovery Duration Minimum	23.5
31	123	MNvit	TX	A2	ST+S9_C1250	9	RCVDTRG	Recovery Duration Target	24
32	123	MNvit	TX	A2	ST+S9_C1250	10	RCVDMAX	Recovery Duration Maximum	24.5
33	123	MNvit	TX	A2	ST+S9_C1250	11	RCVDU	Recovery Duration Unit	HOURS
34	123	MNvit	TX	A2	ST+S9_C1250	12	INCBTMP	Incubation Temperature	37
35	123	MNvit	TX	A2	ST+S9_C1250	13	INCBTMPU	Incubation Temperature Unit	C
36	123	MNvit	TX	A2	ST+S9_C1250	14	HUMID	Atmospheric Relative Humidity Percent	50
37	123	MNvit	TX	A2	ST+S9_C1250	15	ATMCO2	Atmospheric CO2 Percent	5
38	123	MNvit	TX	A2	ST+S9_C1250	16	SPTOBID	Sponsor defined tobacco identifier	CIG01a
39	123	MNvit	TX	A2	ST+S9_C1250	17	EXPTYP	Exposure Type	Submerged
40	123	MNvit	TX	A2	ST+S9_C1250	18	SAMTYP	Sample Type	Total Particulate Matter in DMSO
41	123	MNvit	TX	A2	ST+S9_C1250	19	INTRVN	Name of the Intervention Article	Tobacco ProdA
42	123	MNvit	TX	A2	ST+S9_C1250	20	ITVTYPE	type of intervention article	Product
43	123	MNvit	TX	A2	ST+S9_C1250	21	ITVCONC	Concentration of intervention article	1250
44	123	MNvit	TX	A2	ST+S9_C1250	22	ITVCONCU	Concentration Unit	ug/ml
45	123	MNvit	TX	A2	ST+S9_C1250	23	SPDEVID	Sponsor defined device identifier	PUFFMASTER2023
46	123	MNvit	TX	A2	ST+S9_C1250	24	DUREFID	Smoke Regimen	High Intensity Regimen

Dataset wrap

Name	relref.xpt

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. LEVEL=1 and LVLDESC='EXPERIMENTAL UNIT/TRIAL SET' indicates this identifier relates is referring to the entire trial setboth the experimental unit, the unit to which the treatment is applied, and the entire trial set.
Rows 2-5:	Show the values of four observational units C0_Count1 through C0_Count4 that are within the parent experimental unit, REFID=C0, and in this example assay these observational units are also all within the same trial set, as defined in the trial set dataset, tx.xpt.
Rows 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. LEVEL=1 and LVLDESC='EXPERIMENTAL UNIT/TRIAL SET' indicates this identifier is referring to both the experimental unit, the unit to which the treatment is applied, and the entire trial set.
Row 7-10:	Show the values of four observational units C1250_Count1 through C1250_Count4 that are within the parent experimental unit, REFID=C0, and in this example assay these observational units are also all within the same trial set, as defined in the trial set dataset, tx.xpt.	Row 7-10:	Show the values of four

Dataset2

tableid	relref.xpt

10

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
	C0	6	123	MNvit	A2	C1250	1	EXPERIMENTAL UNIT/TRIAL SET	7	123	MNvit	A2	C1250-Count1	C1250	2	OBSERVATIONAL UNIT8
5	123	MNvit	A2 A1	C1250C0-Count2Count4C1250	C0	2	OBSERVATIONAL UNIT9
6	123	MNvit	A2C1250-Count3	C1250		21OBSERVATIONAL	EXPERIMENTAL UNIT/TRIAL SET
7	123	MNvit	A2	C1250-Count4	C1250	2	OBSERVATIONAL UNIT

A1: Image Removed

A2: Image Removed

1

Count1	C1250	2	OBSERVATIONAL UNIT
8	123	MNvit	A2	C1250-Count2	C1250	2	OBSERVATIONAL UNIT
9

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title	ou.xpt

Row

STUDYID

ASSAYID

DOMAIN

SETCD

EUID

OBUID

123

MNvit

EI

A2

A1

C1250-Count3

C0

C1250	2	OBSERVATIONAL UNIT
10	123	MNvit

EIA2C1250

A2

C1250-Count4

C1250

2

OBSERVATIONAL UNIT

A1: Image Added

A2: Image Added

Dataset wrap

Name	gt.xpt

Rowcaps

Rows 1-5:	Show the number of revertant colonies per plate collected for each of five observational units ( REFID=0_1 through 0_5 as described in the relref dataset).
Rows 6, 7:	Show summary values collected (MEAN, STANDARD DEVIATION) for REFID=A that apply to the entire trial set, SetA, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the relref dataset.
Rows 8-13:	Revertent colonies were counted for each of three plates/observational units (REFID=6_1 through 6_3) and each value is associated with a record to show a postfix code of "V" = "Very thin background bacterial lawn"
Rows 14-16:	Show summary values collected (MEAN, STANDARD DEVIATION, and FOLD INCREASE) for REFID=F that apply to the entire trial set, SetF, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the relref dataset.
Rows 17-19:	Show three plates/observational units (REFID=5_1 through 5_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T".
Rows 20-22:	Show the number of revertant colonies per plate collected for each of three observational units (REFID=18_1 through 18_3 as described in the relref dataset).
Rows 23-25:	Show summary values collected (MEAN, STANDARD DEVIATION, and FOLD INCREASE) for REFID=R that apply to the entire trial set, SetR, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the relref dataset.

Dataset2

Row	STUDYID	GNTXAID	DOMAIN

EUID

OBUID

REFID	GTSEQ	GTTESTCD	GTTEST	GTCELLEV	GTORRES	GTORRESU	GTCOLSRT	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC
1	123	MNvit	GT

C0

	C0	1	RICC	Relative Increase in Cell Count	154	0	%		0	0	%	2022-05-25
2	123	MNvit	GT

C0

	C0	2	RCC	Relative Cell Count	154	0	%		0	0	%	2022-05-25
3	123	MNvit	GT

C0

	C0	3	RPD	Relative Population Doubling	154	0	%		0	0	%	2022-05-25
4	123	MNvit	GT

C0

	C0-Count1	4	MNCELLS	Micronucleated Cells	2205	15	Cells		15	15	Cells	2022-05-25
5	123	MNvit	GT

C0

	C0-Count2	5	MNCELLS	Micronucleated Cells	2474	13	Cells		13	13	Cells	2022-05-25
6	123	MNvit	GT	C0

C0

-Count3	6	MNCELLS	Micronucleated Cells	2758	17	Cells		17	17	Cells	2022-05-25
7	123	MNvit	GT

C0

	C0-Count4	7	MNCELLS	Micronucleated Cells	2669	12	Cells		12	12	Cells	2022-05-25
8	123	MNvit	GT	C0

C0

8	AVGREL	Average Relative MN Frequency		0.57	%		0.57	0.57	%	2022-05-25
9	123	MNvit	GT

C1250

	C1250	1	RICC	Relative Increase in Cell Count	134	15.7	%		15.7	15.7	%	2022-05-25
10	123	MNvit	GT

C1250

	C1250	2	RCC	Relative Cell Count	134	13.0	%		13.0	13.0	%	2022-05-25
11	123	MNvit	GT

C1250

	C1250	3	RPD	Relative Population Doubling	134	7.9	%		7.9	7.9	%	2022-05-25
12	123	MNvit	GT

C1250

	C1250-Count1	4	MNCELLS	Micronucleated Cells	3266	20	Cells		20	20	Cells	2022-05-25
13	123	MNvit	GT	C1250

C1250

-Count2	5	MNCELLS	Micronucleated Cells	2190	17	Cells		17	17	Cells	2022-05-25
14	123	MNvit	GT

C1250

	C1250-Count3	6	MNCELLS	Micronucleated Cells	2758	13	Cells		13	13	Cells	2022-05-25
15	123	MNvit	GT	C1250

C1250

-Count4	7	MNCELLS	Micronucleated Cells	2714	21	Cells		21	21	Cells	2022-05-25
16	123	MNvit	GT

C1250

8

AVGREL

Average Relative MN Frequency

0.66

%

0.66

%

2022-05-25

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