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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 (e.g. Average, Standard Deviation, Coeff. Var.) for each plate and an EC50 value for the entire assay. The grey cells in plate 1 are cells that do not contain the CHO Hamster cells.

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)
	Sample ID	Smoke Regime	Replicate Number	Plate Number	Well Number		Relative Assay Plate Absorbance Readings
							Cigarette Smoke Condensate (µg/mL)								SLS (µg/mL)			EC50 (µg/ml)
						0	10	50	75	100	120	140	160	200	110	200	0
	030001	Medium	1	1	1	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	2	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	3	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	4	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	5	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	6	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	7	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	8	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	1		93.4	74.0	56.0	35.1	11.8	8.70	5.10	1.98	5.34	1.02
	030001	Medium	1	2	2		102	75.2	53.3	35.1	11.8	7.74	5.58	3.66	5.34	1.02
	030001	Medium	1	2	3		107	79.0	55.0	26.5	10.1	6.06	3.66	1.74	7.02	0.780
	030001	Medium	1	2	4		104	80.2	55.3	29.8	8.94	3.90	3.66	1.50	6.30	0.780
	030001	Medium	1	2	5		101	75.7	54.1	26.7	4.86	4.38	1.26	1.02	6.30	1.02
	030001	Medium	1	2	6		110	85.7	67.7	26.0	5.34	4.62	3.42	1.50	6.30	0.540
	030001	Medium	1	2	7		104	77.8	64.9	27.7	8.22	3.18	2.46	1.02	6.30	0.780
	030001	Medium	1	2	8		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). (could also be EC20 or EC30, EC70, etc.)																		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	GNTXAID	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 No. 07-4519
15	123	NRU	TS	1		ASTDV	Assay Standard Version	2006-11
16	123	NRU	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
17	123	NRU	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake
18	123	NRU	TS	1		SPECIES	Species	Hamster
19	123	NRU	TS	1		TESTSYS	Test System	CHO

Dataset wrap

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-279

Rowcaps

Rows 1-12:	Show the test conditions for the set with a short name or SETCD value of ALL. The sponsor chose this value to represent test conditions for the entire assay.
Rows 13-20:	Show the test conditions for the set with a short name or SETCD value of CSC-50b. The sponsor chose this value to represent plate number 1, well number 1, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Row

17

20:	Shows the value for STRAIN/SUBSTRAIN is NO STRAIN because the well is a media only well, having no CHO Hamster cells.
Rows 21-

40

28:	Show the test conditions for the set with a short name or SETCD value of CSC-50. The sponsor chose this value to represent plate number 1, well number 2, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Rows

41

29-

60

36:	Show the test conditions for the set with a short name or SETCD value of SLS-110. The sponsor chose this value to represent both wells numbered 7 in plate number 1 and 2, with a concentration of 110µg/mLof Sodium Laurel Sulfate as shown in the report table for study 123.

Dataset2

Air Liquid InterfaceNO STRAINPUFFMASTER3kMedium Intensity RegimenCIG01a47.54848.5HOURS295354555657585960CIG01a

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	1	TRTDMIN	Treatment Duration Minimum	47.5
2	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	2	TRTDTRG	Treatment Duration Target	48
3	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	3	TRTDMAX	Treatment Duration Maximum	48.5
4	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	4	TRTDU	Treatment Duration Unit	HOURS
5	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	5	INCBTMP	Incubation Temperature	37
6	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	6	INCBTMPU	Incubation Temperature Unit	C
7	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	7	WAVELGTH	Spectrophotometer wavelength in nanometers	540
8	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	8	HUMID	Atmospheric Relative Humidity Percent	90
9	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	9	ATMCO2	Atmospheric CO2 Percent	5
10	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	10	SPTOBIDSPDEVID	Sponsor defined tobacco device identifierCIG01a	PUFFMASTER3k
11	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	11	EXPTYPDUREFID	Exposure Type	Smoking Regime	Medium Intensity Regimen
12	123	NRU	TX	CSC-50b	ALL	ALL_ASSAYCSC-50-blank	12	SAMTYP	Sample Type	SPTOBID	Sponsor defined tobacco identifier	CIG01aWhole Smoke Conditioned Media
13	123	NRU	TX	CSC-50b	CSC-50-blank	13	INTRVN	Name of the Intervention Article	PSETCD	Parent Set Code	ALLTobacco ProdA
14	123	NRU	TX	CSC-50b	CSC-50-blank	14	ITVTYPE	type of intervention article	EXPTYP	Exposure Type	Air Liquid InterfacePRODUCT
15	123	NRU	TX	CSC-50b	CSC-50-blank	15	ITVCONCSAMTYP	intervention concentration	Sample Type	Whole Smoke Conditioned Media50
16	123	NRU	TX	CSC-50b	CSC-50-blank	16	ITVCONCU	intervention unit	INTRVN	Name of the Intervention Article	Tobacco ProdAug/ml
17	123	NRU	TX	CSC-50b	CSC-50-blank	17	STRAIN	Strain/Substrain	ITVTYPE	type of intervention article	PRODUCT
18	123	NRU	TX	CSC-50b	CSC-50-blank	18	SPDEVID	Sponsor defined device identifier	ITVCONC	intervention concentration	50
19	123	NRU	TX	CSC-50b	CSC-50-blank	19	DUREFIDITVCONCU	Smoking Regime	intervention unit	ug/ml
20	123	NRU	TX	CSC-50b	CSC-50-blank	20	SPTOBID	Sponsor defined tobacco identifier	STRAIN	Strain/Substrain	NO STRAIN
21	123	NRU	TX	CSC-50	CSC-50	121	TRTDMIN	Treatment Duration Minimum	PSETCD	Parent Set Code	ALL
22	123	NRU	TX	CSC-50	CSC-50	222	TRTDTRG	Treatment Duration Target	EXPTYP	Exposure Type	Air Liquid Interface
23	123	NRU	TX	CSC-50	CSC-50	323	TRTDMAX	Treatment Duration Maximum	SAMTYP	Sample Type	Whole Smoke Conditioned Media
24	123	NRU	TX	CSC-50	CSC-50	424	TRTDU	Treatment Duration Unit	INTRVN	Name of the Intervention Article	Tobacco ProdA
25	123	NRU	TX	CSC-50	CSC-50	525	INCBTMP	Incubation Temperature	ITVTYPE	type of intervention article	PRODUCT37
26	123	NRU	TX	CSC-50	CSC-50	626	INCBTMPU	Incubation Temperature Unit	ITVCONC	intervention concentration	50C
27	123	NRU	TX	CSC-50	CSC-50	727	WAVELGTH	Spectrophotometer wavelength in nanometers	540
28	123	NRU	TX	CSC-50	CSC-50	8	HUMID	Atmospheric Relative Humidity Percent	90
ITVCONCU	intervention unit	ug/ml
28		123	NRU	TX	CSC-50	CSC-50	9	ATMCO2	Atmospheric CO2 Percent	5
30	123	NRU	TX	CSC-50	CSC-50	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
31	123	NRU	TX	CSC-50	CSC-50	11	EXPTYP	Exposure Type	Air Liquid Interface
32	123	NRU	TX	CSC-50	CSC-50	12	SAMTYP	Sample Type	Whole Smoke Conditioned Media
33	123	NRU	TX	CSC-50	CSC-50	13	INTRVN	Name of the Intervention Article	Tobacco ProdA
34	123	NRU	TX	CSC-50	CSC-50	14	ITVTYPE	type of intervention article	PRODUCT
35	123	NRU	TX	CSC-50	CSC-50	15	ITVCONC	intervention concentration	50
36	123	NRU	TX	CSC-50	CSC-50	16	ITVCONCU	intervention unit	ug/ml
37	123	NRU	TX	CSC-50	CSC-50	17	STRAIN	Strain/Substrain	CHO
38	123	NRU	TX	CSC-50	CSC-50	18	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
39	123	NRU	TX	CSC-50	CSC-50	19	DUREFID	Smoking Regime	Medium Intensity Regimen
40	123	NRU	TX	CSC-50	CSC-50	20	SPTOBID	Sponsor defined tobacco identifier	CIG01a
41	123	NRU	TX	SLS-110	SLS-110	1	TRTDMIN	Treatment Duration Minimum	47.5
42	123	NRU	TX	SLS-110	SLS-110	2	TRTDTRG	Treatment Duration Target	48
43	123	NRU	TX	SLS-110	SLS-110	3	TRTDMAX	Treatment Duration Maximum	48.5
44	123	NRU	TX	SLS-110	SLS-110	4	TRTDU	Treatment Duration Unit	HOURS
45	123	NRU	TX	SLS-110	SLS-110	5	INCBTMP	Incubation Temperature	37
46	123	NRU	TX	SLS-110	SLS-110	6	INCBTMPU	Incubation Temperature Unit	C
47	123	NRU	TX	SLS-110	SLS-110	7	WAVELGTH	Spectrophotometer wavelength in nanometers	540
48	123	NRU	TX	SLS-110	SLS-110	8	HUMID	Atmospheric Relative Humidity Percent	90
49	123	NRU	TX	SLS-110	SLS-110	9	ATMCO2	Atmospheric CO2 Percent	5
50	123	NRU	TX	SLS-110	SLS-110	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
51	123	NRU	TX	SLS-110	SLS-110	11	EXPTYP	Exposure Type	Air Liquid Interface
52	123	NRU	TX	SLS-110	SLS-110	12	SAMTYP	Sample Type	Liquid
	CSC-50	28	STRAIN	Strain/Substrain	CHO
29		123	NRU	TX	SLS-110	SLS-110	1329	INTRVN	Name of the Intervention Article	Sodium Laurel Sulfate	PSETCD	Parent Set Code	ALL
30		123	NRU	TX	SLS-110	SLS-110	1430	ITVTYPE	type of intervention article	POSITIVE CONTROL	EXPTYP	Exposure Type	Air Liquid Interface
31		123	NRU	TX	SLS-110	SLS-110	1531	ITVCONCSAMTYP	intervention concentrationSample Type	200Liquid
32	123	NRU	TX	SLS-110	SLS-110	1632	ITVCONCU	intervention unit	ug/ml	INTRVN	Name of the Intervention Article	Sodium Laurel Sulfate
33		123	NRU	TX	SLS-110	SLS-110	1733	STRAIN	Strain/Substrain	CHO	ITVTYPE	type of intervention article	POSITIVE CONTROL
34		123	NRU	TX	SLS-110	SLS-110	1834	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k	ITVCONC	intervention concentration	200
35		123	NRU	TX	SLS-110	SLS-110	1935	DUREFIDITVCONCU	Smoking Regime	Medium Intensity Regimen	intervention unit	ug/ml
36		123	NRU	TX	SLS-110	SLS-110	2036	SPTOBID	Sponsor defined tobacco identifier	STRAIN	Strain/Substrain	CHO

Dataset wrap

Name	relref

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-280

Rowcaps

Row 1:	Shows the REFID of 123NRU that indicates the entire assay.
Rows 2, 5, 8, 9:	Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3b, 1-3, 1-10, 2-10).
Rows 3-4, 6-7, 10-11:	Show REFID values that the sponsor chose, in this case, to represent the plate number (1 or 2), column (1 - 10), and row (A-G) of the 96-well plate.
Rows 3-4:	Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units within the parent Trial Set of 1-3b.
Rows 6-7:	Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units within the parent Trial Set of 1-3.
Row 10:	Shows the REFID of 1-10-G that indicates the experimental unit within the parent Trial Set of 1-10.
Row 11:	Shows the REFID of 2-10-G that indicates the experimental unit within the parent Trial Set of 2-10.

Dataset2

tableid	relref

Row	STUDYID	GNTXAID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123	NRU	ALL	123NRU		1	ASSAY
2	123	NRU	CSC-50b	1-3b	123NRU	2	TRIAL SET
3	123	NRU	CSC-50b	1-3-A	1-3b	3	EXPERIMENTAL UNIT
4	123	NRU	CSC-50b	1-3-H	1-3b	3	EXPERIMENTAL UNIT
5	123	NRU	CSC-50	1-3	123NRU	2	TRIAL SET
6	123	NRU	CSC-50	1-3-B	1-3	3	EXPERIMENTAL UNIT
7	123	NRU	CSC-50	1-3-C	1-3	3	EXPERIMENTAL UNIT
8	123	NRU	SLS-110	1-10	123NRU	2	TRIAL SET
9	123	NRU	SLS-110	2-10	123NRU	2	TRIAL SET
10	123	NRU	SLS-110	1-10-G	1-10	3	EXPERIMENTAL UNIT
11	123	NRU	SLS-110	2-10-G	2-10	3	EXPERIMENTAL UNIT

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