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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)
						10	50	75	100	120	140	160	200	110	200
1-1	030001	A	1	1	1	100	83.0	56.7	29.5	13.0	8.57	4.44	1.76	13.7	0.547
1-1	030001	A	1	1	2	107	77.7	65.7	30.2	15.6	9.79	5.41	2.49	8.09	0.791
1-1	030001	A	1	1	3	98.6	77.4	57.7	35.8	8.09	7.36	3.22	0.791	6.38	0.061
1-1	030001	A	1	1	4	94.9	81.5	38.2	31.2	7.60	5.17	3.22	0.791	5.17	0.304
1-1	030001	A	1	1	5	111	78.1	64.5	32.9	8.82	5.90	2.74	1.28	10.3	0.547
1-1	030001	A	1	1	6	96.6	76.2	48.0	26.8	7.84	4.20	2.74	1.52	8.09	4.93
1-1	030001	A	1	1	7	105	77.9	58.2	28.3	8.09	4.68	1.76	0.547	8.57	1.76
1-1	030001	A	1	1	8	95.2	74.0	47.2	24.4	8.57	3.71	3.47	0.304	11.2	0.791
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
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	Image Added

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)
						10	50	75	100	120	140	160	200	110	200
1-1	030001	A	1	1	1	100	83.0	56.7	29.5	13.0	8.57	4.44	1.76	13.7	0.547
1-1	030001	A	1	1	2	107	77.7	65.7	30.2	15.6	9.79	5.41	2.49	8.09	0.791
1-1	030001	A	1	1	3	98.6	77.4	57.7	35.8	8.09	7.36	3.22	0.791	6.38	0.061
1-1	030001	A	1	1	4	94.9	81.5	38.2	31.2	7.60	5.17	3.22	0.791	5.17	0.304
1-1	030001	A	1	1	5	111	78.1	64.5	32.9	8.82	5.90	2.74	1.28	10.3	0.547
1-1	030001	A	1	1	6	96.6	76.2	48.0	26.8	7.84	4.20	2.74	1.52	8.09	4.93
1-1	030001	A	1	1	7	105	77.9	58.2	28.3	8.09	4.68	1.76	0.547	8.57	1.76
1-1	030001	A	1	1	8	95.2	74.0	47.2	24.4	8.57	3.71	3.47	0.304	11.2	0.791
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
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	Image Added

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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
BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level
For the items highlighted in orange - what is the lowest level where this could vary? e.g. at the level of a well in a 96-well plate, or a slide vs. assay level vs. product level
- Smoke Regime needs to be allowed to vary down to the well level / result level
- run - also at result level
- port - (smoking product on the machine, you assign a run number or port-number for multiple replicates depending on linear vs. rotary machines; machine bias), needs to be allowed to vary down to the well level / result level)
- replicate - (e.g., multiple samples from one vial), could be a replicate per exposure (e.g., 3 plates, multiple analyses for exposure)
- sample ID - typically a unique number assigned (at CRO) or supplied by sponsor - result level
- Smoke fraction - result level (e.g.tpm particulate vs. gas gvp)

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1

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

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
BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level
For the items highlighted in orange - what is the lowest level where this could vary? e.g. at the level of a well in a 96-well plate, or a slide vs. assay level vs. product level
- Smoke Regime needs to be allowed to vary down to the well level / result level
- run - also at result level
- port - (smoking product on the machine, you assign a run number or port-number for multiple replicates depending on linear vs. rotary machines; machine bias), needs to be allowed to vary down to the well level / result level)
- replicate - (e.g., multiple samples from one vial), could be a replicate per exposure (e.g., 3 plates, multiple analyses for exposure)
- sample ID - typically a unique number assigned (at CRO) or supplied by sponsor - result level
- Smoke fraction - result level (e.g.tpm particulate vs. gas gvp)

Dr. R. SmithYMNvitOECD Test No. 487 MNvit12016-07-29MNvitGENOTOXICITY IN VITROMNvitIn Vitro MicronucleusMNvitSPECIESHomo SapiensMNvitTK6 Lymphoblastoid Suspension CellsNRUNIH Publication 07-4519NRU200611NRUNRUSalmonella enterica NRUSTRAINSalmonella enterica entericaNRU?Normal Human KeratinocyteREGIMETraditional combustible 030001SMKFRCA1

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	ALL	TS	1	GLPTYP	Good Laboratory Practice Type	FDA	2	123	ALL	TS	2	GLPTYP	Good Laboratory Practice Type	OECD	3	123	ALL	TS	1	STSTDTC	Study Start Date	2022-05-25	4	123	ALL	TS	1	STITLE	Study Title	Determination of the in vitro genotoxicity potential of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake	5	123	ALL	TS	1	SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0	6	123	ALL	TS	1	SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30	7	123	ALL	TS	1	GLPTYP	Good Laboratory Practice Type	FDA
2	SSPONSOR	Sponsor Organization	Example Sponsor Inc.	8	123	ALL	TS	12	SPREFID		GLPTYP	Good Laboratory Practice Type	OECD
3	Sponsor's Study Reference ID	NOT APPLICABLE	9	123	ALL	TS	11		STSTDTC	TSTFNAM	Test Facility Name	Example Tox Lab Name	Study Start Date	2022-05-25
410	123	ALL	TS	11		STITLE	TSTFLOC	Test Facility Location	Study Title	Determination of the in vitro genotoxicity potential of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake
5	10 Somewhere Street, Montgomery, AL 10000	11	123	ALL	TS	1	1	TFCNTRY	Test Facility Country	USA		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6	...	123	ALL	TS	1	1	STDIR	Study Director		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
7	123	ALL	TS	1		SSPONSOR	GLPFL	GLP Flag	Sponsor Organization	Example Sponsor Inc.
8		123	ALL	TS	1	ASTD	Assay Standard			SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
9		123	ALL	TS	1	1	TSTFNAM	ASTDV	Assay Standard Version	Test Facility Name	Example Tox Lab Name
10		123	ALL	TS	1	1	TSTFLOC	SSTYP	Study Type	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
11		123	ALL	TS	1	1	TFCNTRY	SSSTYP	Study Sub Type	Test Facility Country	USA
...		123	ALL	TS	1	1	STDIR	Species	Study Director	Dr. R. Smith
	123	ALL	TS	1	??	Test System?		GLPFL	GLP Flag	Y
	123	MNvit	TS	1		ASTD	Assay Standard	OECD Test No.	487
	123	MNvit	TS	1		ASTDV	Assay Standard Version	2016-07-	29
	123	MNvit	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
	123	MNvit	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake	123	NRU	TS	1	SPECIES	Species		In Vitro Micronucleus
	123	MNvit	TS	1		SPECIES	Strain/Substrain	Species	Homo Sapiens
	123	MNvit	TS	1		??	Test System	?	TK6 Lymphoblastoid Suspension Cells
	123	NRU	TS	1		ASTD	Smoking Regime	Assay Standard	NIH Publication No. 07-4519
	123	NRU	TS	1	RUNPRT	run-port number?? (always same for whole assay?)	1-1		ASTDV	Assay Standard Version	2006-11
	123	NRU	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
	123	NRU	TS	1	SMPLID	Sample ID		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake
	123	NRU	TS	1		SPECIES	Smoke Fraction	Species	Salmonella enterica
	123	NRU	TS	1	REPNUM	Replicate Number		??	Test System??	Normal Human Keratinocyte

Expand

title	tx.xpt (trial sets)

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
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 designations as specified in the trial design.

/ml71--B8TX-B9TX-1-B10TX-BPRODUCT

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	1-1-A (plate-col-row in the 96-well plate)	CSC-10 (through SLS-200)	PLATENUM. (e.g., 1 or 2)	1	1
2	123	NRU	TX	1-1-A	CSC-10	WELLNUM (e.g., 1-A through 10-H)	Number representing the location of the well in the 96-well plate	1-A
3	123	NRU	TX	1-1-A	CSC-10	INTRVN	name of the intervention article	Cigarette Smoke Condensate
4	123	NRU	TX	1-1-A	CSC-10	ITVTYPE (CT e.g, Product, positive control, negative control)	type of intervention article	PRODUCT
5	123	NRU	TX	1-1-A	CSC-10	ITVCONC	intervention concentration	10
6	123	NRU	TX	1-1-A	CSC-10	ITVCONCU	intervention unit	ug	/ml
	123	NRU		1		STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU	TX		1	CSC-10	PLATENUM	Plate number	1			REGIME	Smoking Regime	Traditional combustible
	123	NRU	1-		1	CSC-10	WELLNUM	Number representing the location of the well in the 96-well plate	2-A			RUN	Assay run number (how is this different from REPNUM)	1
	123	NRU		1		PORT	Port ID	1	CSC-10	INTRVN	name of the intervention article	Cigarette Smoke Condensate
	123	NRU		1		SMPLID	Sample ID	030001
	123	NRU		1		SMKFRC	Smoke Fraction	A
	123	NRU	1-		1	CSC-10	ITVTYPE	type of intervention article			REPNUM	Replicate Number	1
11	123	NRU	TX	1-1-B	CSC-10	ITVCONC	intervention concentration	10
12	123	NRU	TX	1-1-B	CSC-10	ITVCONCU	intervention unit	ug/ml
...				...
	123	NRU	TX	1-10-H	SLS-10	PLATENUM	Plate number	1
	123	NRU	TX	1-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	1-10-H	SLS-10	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	1-10-H	SLS-10	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	1-10-H	SLS-10	ITVCONC	intervention concentration	200
	123	NRU	TX	1-10-H	SLS-10	ITVCONCU	intervention unit	ug/ml
...				...
	123	NRU	TX	2-10-H	SLS-10	PLATENUM	Plate number	2
	123	NRU	TX	2-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	2-10-H	SLS-10	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	2-10-H	SLS-10	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	2-10-H	SLS-10	ITVCONC	intervention concentration	200
	123	NRU	TX	2-10-H	SLS-10	ITVCONCU	intervention unit	ug/ml
	123	MNvit	TX	A1		METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
	123	MNvit	TX	A1		TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)	3
	123	MNvit	TX
	123	MNvit	TX			TRTDRTOL	Treatment Duration Tolerance
	123	MNvit	TX			TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	MNvit	TX			INTRVN	name of the intervention article	Bleomycin or Cyclophosphamid A
	123	MNvit	TX			ITVTYPE	type of intervention article	choices of values: product; negative control; positive control
	123	MNvit	TX	A1		ITVCONC	Concentration of i a	0
	123	MNvit	TX	A1		ITVCONCU	Concentration Unit	ug/ml

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Versions Compared

Old Version 34

New Version 35

Key

SET (what sponsor calls it)

(plate-col-row in the 96-well plate)

(through SLS-200)

PLATENUM. (e.g., 1 or 2)

WELLNUM (e.g., 1-A through 10-H)

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