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This example shows a report table, trial design,

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and results data for the in vitro neutral red uptake (NRU) cytotoxicity assay

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in example study 123.

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title	Sample from Report Table

The following shows example data for study 123 in a report table. This report includes summary statistics (i.e., average, standard deviation, coefficient variation) for each plate and an EC50

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key	TOBA-593

value for the entire assay. In value for the entire assay. In the table below, the light grey shading for plate 1 are values from wells that do not contain the NHK cells. The dark grey shading represents the column and row location within the 96-well plate, and in this example the applicant chose to use these column and row locations to assign their REFID values in the RELREF dataset and GT dataset.

For brevity, the datasets in this example are not comprehensive but are intended to demonstrate a range of proper use.

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)
	Sample ID	Smoke Regime	Replicate Number	Plate Number			Relative Assay Plate Absorbance Readings
							Cigarette Smoke Condensate (µg/mL)								SLS (µg/mL)			EC50 (µg/ml)
					Well Column:	1	2	3	4	5	6	7	8	9	10	11	12
					Well Row:	0	10	50	75	100	120	140	160	200	110	200	0
	030001	Medium	1	1	A	0.046*	0.046*	0.039*	0.012*	0.030*	0.003*	0.057*	0.032*	0.003*	0.050*	0.044*	0.040*
	030001	Medium	1	1	B	0.048*	107	77.7	65.7	30.2	15.6	9.79	5.41	2.49	8.09	0.791	0.014*
	030001	Medium	1	1	C	0.005*	98.6	77.4	57.7	35.8	8.09	7.36	3.22	0.791	6.38	0.061	0.050*
	030001	Medium	1	1	D	0.049*	94.9	81.5	38.2	31.2	7.60	5.17	3.22	0.791	5.17	0.304	0.017*
	030001	Medium	1	1	E	0.047*	111	78.1	64.5	32.9	8.82	5.90	2.74	1.28	10.3	0.547	0.011*
	030001	Medium	1	1	F	0.032*	96.6	76.2	48.0	26.8	7.84	4.20	2.74	1.52	8.09	4.93	0.022*
	030001	Medium	1	1	G	0.044*	105	77.9	58.2	28.3	8.09	4.68	1.76	0.547	8.57	1.76	0.056*
	030001	Medium	1	1	H	0.056*	0.013*	0.040*	0.008*	0.013*	0.002*	0.029*	0.018*	0.006*	0.016*	0.024*	0.046*
Average							101	78.2	54.5	29.9	9.70	6.17	3.37	1.19	8.94	1.22
Std. Dev.							6	2.9	9.4	3.6	2.95	2.19	1.12	0.72	2.72	1.58
Coeff. Var.							5.8	3.6	17.2	11.9	30.4	35.5	33.1	61.0	30.5	129.9
*media without cells
	030001	Medium	1	2	A		93.4	74.0	56.0	35.1	11.8	8.70	5.10	1.98	5.34	1.02
	030001	Medium	1	2	B		102	75.2	53.3	35.1	11.8	7.74	5.58	3.66	5.34	1.02
	030001	Medium	1	2	C		107	79.0	55.0	26.5	10.1	6.06	3.66	1.74	7.02	0.780
	030001	Medium	1	2	D		104	80.2	55.3	29.8	8.94	3.90	3.66	1.50	6.30	0.780
	030001	Medium	1	2	E		101	75.7	54.1	26.7	4.86	4.38	1.26	1.02	6.30	1.02
	030001	Medium	1	2	F		110	85.7	67.7	26.0	5.34	4.62	3.42	1.50	6.30	0.540
	030001	Medium	1	2	G		104	77.8	64.9	27.7	8.22	3.18	2.46	1.02	6.30	0.780
	030001	Medium	1	2	H		103	71.6	58.9	25.5	9.42	4.14	3.90	1.26	4.38	0.780
Average							103	77.4	58.1	29.0	8.82	5.34	3.63	1.71	5.91	0.840
Std. Dev.							5	4.4	5.3	4.0	2.63	1.97	1.37	0.86	0.83	0.170
Coeff. Var.							4.6	5.6	9.2	13.6	29.8	36.9	37.6	50.0	14.1	20.2
EC50 (µg/ml). Effective concentration at 50% cytotoxicity. (using a specific sigmoidal equation = model).																		123

Dataset wrap

Rowcaps

TOBA-356

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:

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showSummary

false

server

Issue Tracker (JIRA)

serverId

85506ce4-3cb3-3d91-85ee-f633aaaf4a45

key

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

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

Row 17:

Shows the study type

Row 17:

Shows the study type for this study.

Row 18:

Shows that this study includes a Neutral Red Uptake Assay.

Rows 19-20:

Show that the species is human and the cell line is NHK 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

Organization

	Example Applicant Inc.
9	123	TS	1		APREFID	Applicant Study Reference ID		NOT APPLICABLE
10	123	TS	1	1	TSTFNAM	Test Facility Name	Example Test Lab Name
11	123	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
12	123	TS	1	1	TFCNTRY	Test Facility Country	USA
13	123	TS	1	1	STDIR	Study Director	Dr. R. Smith
14	123	TS	1	4	TSTGDNAM	Testing Guideline Name	Publication No. 07-4519
15	123	TS	1	4	TSTGDORG	Testing Guideline Organization	NIH
16	123	TS	1	4	TSTGDVER	Testing Guideline Version	2006-11
17	123	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
18	123	TS	1		GNTXAID	Genetic Toxicology Assay Identifier	NRU
19	123	TS	1		SPECIES	Species	HUMAN
20	123	TS	1		CELLLN	Cell Line	NHK

TOBA-279

Dataset wrap

Jira

showSummary

false

server

Issue Tracker (JIRA)

serverId

85506ce4-3cb3-3d91-85ee-f633aaaf4a45

key

Rowcaps

Rows 1-12:	Show the test conditions for the set with a short name or SETCD value of NRU. The applicant chose this value to represent test conditions for the entire assay.
Rows 13-2031:	Show the test conditions for the set with a short name or SETCD value of CSC-50b. The applicant chose this value to represent plate number 1, well row A, well column 3, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123. The value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells.
Rows 2132-2850:	Show the test conditions for the set with a short name or SETCD value of CSC-50. The applicant chose this value to represent plate number 1, well rows B-G, well column 3 and plate number 2, well rows A-H, well column 3. These all have the concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123.
Rows 2951-3669:	Show the test conditions for the set with a short name or SETCD value of SLS-110. The applicant chose this value to represent plate number 1, well rows B-G, well column 10, and plate number 2, well rows A-H, well column 10. These all have the concentration of 110µg/mLof sodium laurel sulfate as shown in the report table for study 123.

Dataset2

ORIGINAL

ROW

Row

STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	TX	NRU	NRU_ASSAY	1	IVTDMIN	In vitro Treatment Duration Minimum	47.5
2	123	TX	NRU	NRU_ASSAY	2	IVTDTRG	In vitro Treatment Duration Target	48
3	123	TX	NRU	NRU_ASSAY	3	IVTDMAX	In vitro Treatment Duration Maximum	48.5
4	123	TX	NRU	NRU_ASSAY	4	IVTDU	In vitro Treatment Duration Unit	HOURS
5	123	TX	NRU	NRU_ASSAY	5	INCBTMP	Incubation Temperature	37
6	123	TX	NRU	NRU_ASSAY	6	INCBTMPU	Incubation Temperature Unit	C
7	123	TX	NRU	NRU_ASSAY	7	SWAVENM	Spectrophotometer Wavelength	540
8	123	TX	NRU	NRU_ASSAY	8	ATMRHP	Atmospheric Relative Humidity Percent	90
9	123	TX	NRU	NRU_ASSAY	9	ATMCO2P	Atmospheric CO2 Percent	5
10	123	TX	NRU	NRU_ASSAY	10	SPDEVID	applicant defined device identifier	PUFFMASTER3k
11	123	TX	NRU	NRU_ASSAY	11	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
12	123	TX	NRU	NRU_ASSAY	12	SPTOBID	Applicant-defined tobacco identifier	CIG01a
13	123	TX	CSC-50b	CSC-50-blank	13

PSETCD

Parent Set Code

IVTDMIN

In vitro Treatment Duration Minimum

47.5

NRU


14	123	TX	CSC-50b	CSC-50-blank	14

EXPTYP

Exposure Type

IVTDTRG

In vitro Treatment Duration Target

48

Air Liquid Interface


15	123	TX	CSC-50b	CSC-50-blank	15

SAMTYPSample Type

IVTDMAX

In vitro Treatment Duration Maximum

48.5

Whole Smoke Conditioned Media


16	123	TX	CSC-50b	CSC-50-blank	16

ITVNAMName of the Intervention Article

IVTDU

In vitro Treatment Duration Unit

HOURS

Tobacco ProdA


17	123	TX	CSC-50b	CSC-50-blank	17

ITVTYPEIntervention Article Type

INCBTMP

Incubation Temperature

37

PRODUCT


18	123	TX	CSC-50b	CSC-50-blank	18

ITVCONC

Intervention Article Concentration

INCBTMPU

Incubation Temperature Unit

C

50


19	123	TX	CSC-50b	CSC-50-blank	19

ITVCONCUIntervention Article Concentration Unit

SWAVENM

Spectrophotometer Wavelength

540

ug/ml


20	123	TX	CSC-50b	CSC-50-blank	20

CELLLNCell Line

ATMRHP

Atmospheric Relative Humidity Percent

90

NOT APPLICABLE


21	123	TX	CSC-

50

50b

CSC-50-blank

21

PSETCD

Parent Set Code

ATMCO2P

Atmospheric CO2 Percent

5

NRU


22	123	TX	CSC-

50

50b

CSC-50-blank

22

EXPTYP

Exposure Type

SPDEVID

applicant defined device identifier

PUFFMASTER3k

Air Liquid Interface


23	123	TX	CSC-

50

50b

CSC-50-blank

23

SAMTYP

SMKRGM

Sample Type

Smoking Regimen

MEDIUM INTENSITY REGIMEN

Whole Smoke Conditioned Media


24	123	TX	CSC-

50

50b

CSC-50-blank

24

ITVNAMIntervention Article Name

SPTOBID

Applicant-defined tobacco identifier

CIG01a

Tobacco ProdA


25	123	TX	CSC-

50

50b

CSC-50-blank

25

ITVTYPE

EXPTYP

Intervention Article

Exposure Type

PRODUCT

Air Liquid Interface
26	123	TX	CSC-

50

50b

CSC-50-blank

26

ITVCONC

Intervention Article Concentration

SAMTYP

Sample Type

Whole Smoke Conditioned Media

50


27	123	TX	CSC-

50

50b

CSC-50-blank

27

ITVCONCU

ITVNAM

Name of the Intervention Article

Concentration Unitug/ml

	Tobacco ProdA
28	123	TX	CSC-

50

50b

CSC-50-blank

28

CELLLNCell Line

ITVTYPE

Intervention Article Type

PRODUCT

NHK


29	123	TX

SLS

CSC-

110

50b

SLS

CSC-50-

110

blank

jira

29

showSummary

ITVCONC

falseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-599

Intervention Article Concentration	50
30	123	TX	CSC-50b	CSC-50-blank	30	ITVCONCU	Intervention Article Concentration Unit	ug/ml
31	123	TX	CSC-50b	CSC-50-blank	31	CELLLN	Cell Line	NOT APPLICABLE
32

29PSETCD

Parent Set Code

NRU30123TXSLS-110SLS-11030EXPTYP

Exposure Type

Air Liquid Interface31

123

TX

SLS

CSC-

110

50

SLS

CSC-

110

50

31

32

SAMTYPSample TypeLiquid

IVTDMIN	In vitro Treatment Duration Minimum	47.5
33

32

123

TX

SLS

CSC-

110

50

SLS

CSC-

110

50

32

33

ITVNAMIntervention Article NameSodium Laurel Sulfate

IVTDTRG	In vitro Treatment Duration Target	48
34

33

123

TX

SLS

CSC-

110

50

SLS

CSC-

110

50

33

34

ITVTYPEIntervention Article TypePOSITIVE CONTROL

IVTDMAX	In vitro Treatment Duration Maximum	48.5
35

34

123

TX

SLS

CSC-

110

50

SLS

CSC-

110

50

34

35

ITVCONC

Intervention Article Concentration

110

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-600

IVTDU	In vitro Treatment Duration Unit	HOURS
36	123	TX	CSC-50	CSC-50	36	INCBTMP	Incubation Temperature	37
37

35

123

TX

SLS

CSC-

110

50

SLS

CSC-

110

50

35

37

ITVCONCU

INCBTMPU

Incubation Temperature

Intervention Article Concentration

Unit

ug/ml

C

36

38

123

TX

SLS

CSC-

110

50

SLS

CSC-

110

50

36

38

CELLLN

SWAVENM

Cell Line

Spectrophotometer Wavelength

NHK

540

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Versions Compared

Old Version 127

New Version Current

Key


4	123	GT	4	1-3-C	ABSORB	Absorbance Reading	1.8			1.8	1.8
5	123	GT	5	1-3-C	BKCABS	Background Corrected Absorbance Reading	1.7			1.7	1.7
6	123	GT	6	1-3-C	RELABS	Relative Absorbance Reading	77.4			77.4	77.4
7	123	GT	7	1-3	RELABS	Relative Absorbance Reading	78.2	%	MEAN	78.2	78.2	%
8	123	GT	8	1-3	RELABS	Relative Absorbance Reading	2.9	%	STANDARD DEVIATION	2.9	2.9	%
9	123	GT	9	1-3	RELABS	Relative Absorbance Reading	3.6		COEFFICIENT OF VARIANCE	3.6	3.6
10	123	GT	10	1-10-G	ABSORB	Absorbance Reading	0.7			0.7	0.7
11