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title	Study 123, Report Table

The following shows the tabulated data as it is represented in a report for this study. This report includes summary statistics (e.g. Average, Standard Deviation, Coeff. Var.)

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)
Run-Port Number	Sample ID	Smoke Fraction	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
1-1	030001	A	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*
1-1	030001	A	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*
1-1	030001	A	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*
1-1	030001	A	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*
1-1	030001	A	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*
1-1	030001	A	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*
1-1	030001	A	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*
1-1	030001	A	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
*non-treated control wellsmedia without cells
1-1	030001	A	1	2	1		93.4	74.0	56.0	35.1	11.8	8.70	5.10	1.98	5.34	1.02
1-1	030001	A	1	2	2		102	75.2	53.3	35.1	11.8	7.74	5.58	3.66	5.34	1.02
1-1	030001	A	1	2	3		107	79.0	55.0	26.5	10.1	6.06	3.66	1.74	7.02	0.780
1-1	030001	A	1	2	4		104	80.2	55.3	29.8	8.94	3.90	3.66	1.50	6.30	0.780
1-1	030001	A	1	2	5		101	75.7	54.1	26.7	4.86	4.38	1.26	1.02	6.30	1.02
1-1	030001	A	1	2	6		110	85.7	67.7	26.0	5.34	4.62	3.42	1.50	6.30	0.540
1-1	030001	A	1	2	7		104	77.8	64.9	27.7	8.22	3.18	2.46	1.02	6.30	0.780
1-1	030001	A	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

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title	ts.xpt (trial summary, study level parameters)

Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
Assumption: A Trial (study) can have more than one assay type
Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study

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 Applicant Inc.
8	123	NRU	TS	1		SPREFID	Sponsor Study Reference ID		NOT APPLICABLE
9	123	NRU	TS	1	1	TSTFNAM	Test Facility Name	Example ~~Tox~~ Testing 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

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title	tx.xpt (trial sets)

Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct ~~sponsor~~ applicant designations as specified in the trial design.
During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
Smoke fraction? is this indicator of processing of material from smoke machine..we used Smoke Exposure System - ok?
Incubate cells (37 ºC ±1 ºC, 90% ±10% humidity, and 5% ±1% CO2/air) - these are ranges, do we model for ranges?
- https://ntp.niehs.nih.gov/iccvam/docs/protocols/ivcyto-nhk.pdf

Rows 1-20: Show the values for the

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	CSC-

50

50b	CSC-50-blank	1	TRTDMIN	Treatment Duration Minimum	47.5
2	123	NRU	TX	CSC-

50

50b	CSC-50-blank	2	TRTDTRG	Treatment Duration Target	48
3	123	NRU	TX	CSC-

50

50b	CSC-50-blank	3	TRTDMAX	Treatment Duration Maximum	48.5
4	123	NRU	TX	CSC-

50

50b	CSC-50-blank	4	TRTDU	Treatment Duration Unit	HOURS
5	123	NRU	TX	CSC-

50

50b	CSC-50-blank	5	INCBTMP	Incubation Temperature	37
6	123	NRU	TX	CSC-

50

50b	CSC-50-blank	6	INCBTMPU	Incubation Temperature Unit	C
7	123	NRU	TX	CSC-

50

50b	CSC-50-blank	7	WAVELGTH	Spectrophotometer WAVELENGTH IN NANOMETERS	540
8	123	NRU	TX	CSC-

50

50b	CSC-50-blank	8	HUMID	Atmospheric Relative Humidity Percent	90
9	123	NRU	TX	CSC-50b	CSC-50-blank	9	ATMCO2	Atmospheric CO2 Percent	5
10	123	NRU	TX	CSC-50b	CSC-50-blank	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
11	123	NRU	TX	CSC-50b	CSC-50-blank	11	EXPTYP	Exposure Type	Air Liquid Interface
12	123	NRU	TX	CSC-50b	CSC-50-blank	12	SAMTYP	Sample Type	Whole Smoke Conditioned Media
13	123	NRU	TX	CSC-50b	CSC-50-blank	13	INTRVN	Name of the Intervention Article	Tobacco ProdA
14	123	NRU	TX	CSC-50b	CSC-50-blank	14	ITVTYPE (CT e.g, Product, positive control, negative control, vehicle control, solvent control)	type of intervention article	PRODUCT
15	123	NRU	TX	CSC-50b	CSC-50-blank	15	ITVCONC	intervention concentration	50
16	123	NRU	TX	CSC-50b	CSC-50-blank	16	ITVCONCU	intervention unit	ug/ml
17	123	NRU	TX	CSC-50b	CSC-50-blank	17	STRAIN	Strain/Substrain	NO STRAIN
18	123	NRU	TX	CSC-50b	CSC-50-blank	18	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
19	123	NRU	TX	CSC-50b	CSC-50-blank	19	DUREFID	Smoking Regime	Medium Intensity Regimen
20	123	NRU	TX	CSC-50b	CSC-50-blank	20	SPTOBID	Sponsor defined tobacco identifier	CIG01a

1	123	NRU	TX	CSC-50	CSC-50	1	TRTDMIN	Treatment Duration Minimum	47.5
2	123	NRU	TX	CSC-50	CSC-50	2	TRTDTRG	Treatment Duration Target	48
3	123	NRU	TX	CSC-50	CSC-50	3	TRTDMAX	Treatment Duration Maximum	48.5
4	123	NRU	TX	CSC-50	CSC-50	4	TRTDU	Treatment Duration Unit	HOURS
5	123	NRU	TX	CSC-50	CSC-50	5	INCBTMP	Incubation Temperature	37
6	123	NRU	TX	CSC-50	CSC-50	6	INCBTMPU	Incubation Temperature Unit	C
7	123	NRU	TX	CSC-50	CSC-50	7	WAVELGTH	Spectrophotometer WAVELENGTH IN NANOMETERS	540
8	123	NRU	TX	CSC-50	CSC-50	8	HUMID	Atmospheric Relative Humidity Percent	90
9	123	NRU	TX	CSC-50	CSC-50	9	ATMCO2	Atmospheric CO2 Percent	5
10	123	NRU	TX	CSC-50	CSC-50	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
11	123	NRU	TX	CSC-50	CSC-50	11	EXPTYP	Exposure Type	Air Liquid Interface
12	123	NRU	TX	CSC-50	CSC-50	12	SAMTYP	Sample Type	Whole Smoke Conditioned Media
13	123	NRU	TX	CSC-50	CSC-50	13	INTRVN	Name of the Intervention Article	Tobacco ProdA
14	123	NRU	TX	CSC-50	CSC-50	14	ITVTYPE (CT e.g, Product, positive control, negative control, vehicle control, solvent control)	type of intervention article	PRODUCT
15	123	NRU	TX	CSC-50	CSC-50	15	ITVCONC	intervention concentration	50
16	123	NRU	TX	CSC-50	CSC-50	16	ITVCONCU	intervention unit	ug/ml
17	123	NRU	TX	CSC-50	CSC-50	17	STRAIN	Strain/Substrain	CHO
18	123	NRU	TX	CSC-50	CSC-50	18	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
19	123	NRU	TX	CSC-50	CSC-50	19	DUREFID	Smoking Regime	Medium Intensity Regimen
20	123	NRU	TX	CSC-50	CSC-50	20	SPTOBID	Sponsor defined tobacco identifier	CIG01a
21	123	NRU	TX	SLS-110	SLS-110	1	TRTDMIN	Treatment Duration Minimum	47.5
22	123	NRU	TX	SLS-110	SLS-110	2	TRTDTRG	Treatment Duration Target	48
23	123	NRU	TX	SLS-110	SLS-110	3	TRTDMAX	Treatment Duration Maximum	48.5
24	123	NRU	TX	SLS-110	SLS-110	4	TRTDU	Treatment Duration Unit	HOURS
25	123	NRU	TX	SLS-110	SLS-110	5	INCBTMP	Incubation Temperature	37
26	123	NRU	TX	SLS-110	SLS-110	6	INCBTMPU	Incubation Temperature Unit	C
27	123	NRU	TX	SLS-110	SLS-110	7	WAVELGTH	Spectrophotometer WAVELENGTH IN NANOMETERS	540
28	123	NRU	TX	SLS-110	SLS-110	8	HUMID	Atmospheric Relative Humidity Percent	90
29	123	NRU	TX	SLS-110	SLS-110	9	ATMCO2	Atmospheric CO2 Percent	5
30	123	NRU	TX	SLS-110	SLS-110	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
31	123	NRU	TX	SLS-110	SLS-110	11	EXPTYP	Exposure Type	Air Liquid Interface
32	123	NRU	TX	SLS-110	SLS-110	12	SAMTYP	Sample Type	Liquid
33	123	NRU	TX	SLS-110	SLS-110	13	INTRVN	Name of the Intervention Article	Sodium Laurel Sulfate
34	123	NRU	TX	SLS-110	SLS-110	14	ITVTYPE (CT e.g, Product, positive control, negative control, vehicle control, solvent control)	type of intervention article	POSITIVE CONTROL
35	123	NRU	TX	SLS-110	SLS-110	15	ITVCONC	intervention concentration	200
36	123	NRU	TX	SLS-110	SLS-110	16	ITVCONCU	intervention unit	ug/ml
37	123	NRU	TX	SLS-110	SLS-110	17	STRAIN	Strain/Substrain	CHO
38	123	NRU	TX	SLS-110	SLS-110	18	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
39	123	NRU	TX	SLS-110	SLS-110	19	DUREFID	Smoking Regime	Medium Intensity Regimen
40	123	NRU	TX	SLS-110	SLS-110	20	SPTOBID	Sponsor defined tobacco identifier	CIG01a

2

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title	ou.xpt Observational and Experimental Units Domain

relref.xpt

Row	STUDYID	ASSAYID	SETCD

	REFID	PARENT	LEVEL
1	123	NRU	ALL	123NRU		1
2	123	NRU	CSC-50b	1-3-A	123NRU	2
3	123	NRU	CSC-50b	1-3-H	123NRU	2
4

REFID

PARENT

LEVEL

1

123

NRU

ALL

123NRU

1

123

NRU

CSC-50

1-3

123NRU

2

3

5

123

NRU

CSC-50

1-3-B

1-3

3

4

6	123	NRU	CSC-50	1-3-C	1-3	3
5	123	NRU	SLS-110	1-10	123NRU	2
6	123	NRU	SLS-110	2-10	123NRU	2
7	123	NRU	SLS-110	1-10-G	1-10	3
8	123	NRU	SLS-110	2-10-G	2-10	3

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Versions Compared

Old Version 53

New Version 54

Key

SET (what sponsor calls it)

(CT e.g, Product, positive control, negative control, vehicle control, solvent control)

(CT e.g, Product, positive control, negative control, vehicle control, solvent control)

(CT e.g, Product, positive control, negative control, vehicle control, solvent control)