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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.); however, statistics are not included in the SEND standard and will not be represented in the SEND domains example.

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
EC50 (µg/ml). Effective concentration at 50% cytotoxicity. (using a specific sigmoidal equation = model). (could also be EC20 or EC30, EC70, etc.)																		123
*non-treated control wells
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 (mg/ml). Effective concentration at 50% cytotoxicity																		130

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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

2-B2-B~~1-2-C~~110-H110-H10-H10-H10-H10-H10-H...10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H10-H

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX1-2-B (plate-col-row in the 96-well plate)	CSC-50	CSC-50 (through SLS-200)	1	PLATENUM. (e.g., 1 or 2)	1	1
2	123	NRU	TX1	CSC-	50	CSC-50	2	WELLNUM (e.g., 1-A through 10-H)	Number representing the location of the well in a multiple-well plate	2-B
3	123	NRU	TX1	CSC-	50	CSC-50	4	ITVTYPE (CT e.g, Product, positive control, negative control, vehicle control, solvent control)	type of intervention article	PRODUCT
	123	NRU	TX	1CSC-2-B50	CSC-50	5	ITVCONC	intervention concentration	50
	123	NRU	TX	1CSC-2-B50	CSC-50	6	ITVCONCU	intervention unit	ug/ml
	123	NRU	TX	1CSC-2-B50	CSC-50	7	STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU	TX	1CSC-2-B50	CSC-50	8	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
	123	NRU	TX	1CSC-2-B50	CSC-50	9	DUREFID	Smoking Regime	Medium Intensity Regimen
	123	NRU	TX	1CSC-2-B50	CSC-50	10	RUN	Assay run number	1
	123	NRU	TX	1CSC-2-B50	CSC-50	11	SMPLID	Sample ID	030001
	123	NRU	TX	1CSC-2-B50	CSC-50	12	SMKEXSYS	Smoke Exposure System	Cambridge filter pad, eluted in DMSO
	123	NRU	TX	1CSC-2-B50	CSC-50	13	REPNUM	Replicate Number	1
	123	NRU	TX	1CSC-2-B50	CSC-50	14	TRTDMIN	Treatment Duration Min	47.5
	123	NRU	TX	1CSC-2-B50	CSC-50	15	TRTDTRG	Treatment Duration Target	48
	123	NRU	TX	1CSC-2-B50	CSC-50	16	TRTDMAX	Treatment Duration Max	48.5
	123	NRU	TX	1CSC-2-B50	CSC-50	17	TRTDU	Treatment Duration Unit	HOURS
	123	NRU	TX	1CSC-2-B50	CSC-50	18	INCBTMP	Incubation Temperature	37
	123	NRU	TX	1CSC-2-B50	CSC-50	19	INCBTMPU	Incubation Temperature Unit	~~Composition of Media~~C	~~123~~	~~NRU~~	TX	~~1-2-B~~	~~CSC-50~~	20	~~MEDIA~~	~~Sartorius HEK293~~
							WAVELGTH	Spectrophotometer WAVELENGTH IN NANOMETERS	540
	123	NRU	TX	1CSC-2-B50	CSC-50	21	HUMID	Atmospheric Relative Humidity Percent	90
	123	NRU	TX	1CSC-2-B50	CSC-50	22	ATMCO2	Atmospheric CO2 Percent	5
	123	NRU	TX	1CSC-2-B50	CSC-50	23	SPTOBID	Sponsor defined tobacco identifier	CIG01a
	123	NRU	TX	1CSC-2-B50	CSC-50	24	EXPTYP	Exposure Type	Air Liquid Interface
	123	NRU	TX	1CSC-2-B50	CSC-50	25	SAMTYP	Sample Type	Whole Smoke Conditioned Media
	123	NRU	TX	1CSC-2-C50	CSC-50	1	PLATENUM. (e.g., 1 or 2)	1	1
	123	NRU	TX	1CSC-2-C50	CSC-50	2	WELLNUM (e.g., 1-A through 10-H)	Number representing the location of the well in the 96-well plate	1-A
	123	NRU	TX	1-2-C	CSC-50	CSC-50	3	INTRVN	name of the intervention article	Cigarette Smoke Condensate
	123	NRU	TX	1CSC-2-C50	CSC-50	4	ITVTYPE (CT e.g, Product, positive control, negative control)	type of intervention article	PRODUCT
	123	NRU	TX	1CSC-2-C50	CSC-50	5	ITVCONC	intervention concentration	10
	123	NRU	TX	1CSC-2-C50	CSC-50	6	ITVCONCU	intervention unit	ug/ml
	123	NRU	TX	1CSC-2-C50	CSC-50	7	STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU	TX	1CSC-2-C50	CSC-50	8	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
	123	NRU	TX	1CSC-2-C50	CSC-50	9	DUREFID	Smoking Regime	Medium Intensity Regimen
	123	NRU	TX	1CSC-2-C50	CSC-50	10	RUN	Assay run number	1
	123	NRU	TX	1CSC-2-C50	CSC-50	11	SMPLID	Sample ID	030001
	123	NRU	TX	1CSC-2-C50	CSC-50	12	SMKEXSYS	Smoke Exposure System	Cambridge filter pad, eluted in DMSO
	123	NRU	TX	1CSC-2-C50	CSC-50	13	REPNUM	Replicate Number	1
	123	NRU	TX	1CSC-2-C50	CSC-50	14	TRTDMIN	Treatment Duration Min	47.5
	123	NRU	TX	1CSC-2-C50	CSC-50	15	TRTDTRG	Treatment Duration Target	48
	123	NRU	TX	1CSC-2-C50	CSC-50	16	TRTDMAX	Treatment Duration Max	48.5
	123	NRU	TX	1CSC-2-C50	CSC-50	17	TRTDU	Treatment Duration Unit	HOURS
	123	NRU	TX	1CSC-2-C50	CSC-50	18	INCBTMP	Incubation Temperature	37
	123	NRU	TX	1CSC-2-C50	CSC-50	19	INCBTMPU	Incubation Temperature Unit	C
	~~123~~	~~NRU~~	TX				20	~~MEDIA~~	~~Composition of Media~~	~~Sartorius HEK293~~
	123	NRU	TX	1CSC-2-C50	CSC-50	21	HUMID	Atmospheric Relative Humidity Percent	90
	123	NRU	TX	1CSC-2-C50	CSC-50	22	ATMCO2	Atmospheric CO2 Percent	5
	123	NRU	TX	1CSC-2-C50	CSC-50	23	SPTOBID	Sponsor defined tobacco identifier	CIG01a
	123	NRU	TX	CSC-	50	CSC-50	24	EXPTYP	Exposure Type	Air Liquid Interface
	123	NRU	TX	CSC-	50	CSC-50	25	SAMTYP	Sample Type	Whole Smoke Conditioned Media
...				...
	123	NRU	TX1	SLS-	110	SLS-110	1	PLATENUM	Plate number	1
	123	NRU	TX1	SLS-	110	SLS-110	2	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	1-10-H	SLS-110	SLS-110	3	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX1	SLS-	110	SLS-110	4	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX1	SLS-	110	SLS-110	5	ITVCONC	intervention concentration	200
	123	NRU	TX1	SLS-	110	SLS-110	6	ITVCONCU	intervention unit	ug/ml
	123	NRU	TX	1SLS-10-H110	SLS-110	7	STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU	TX	1SLS-10-H110	SLS-110	8	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
	123	NRU	TX	1SLS-10-H110	SLS-110	9	DUREFID	Smoking Regime	Medium Intensity Regimen
	123	NRU	TX	1SLS-10-H110	SLS-110	10	RUN	Assay run number	1
	123	NRU	TX	1SLS-10-H110	SLS-110	11	SMPLID	Sample ID	030001
	123	NRU	TX	1SLS-10-H110	SLS-110	12	SMKEXSYS	Smoke Exposure System	Cambridge filter pad, eluted in DMSO
	123	NRU	TX	1SLS-10-H110	SLS-110	13	REPNUM	Replicate Number	1
	123	NRU	TX	1SLS-10-H110	SLS-110	14	TRTDMIN	Treatment Duration Min	47.5
	123	NRU	TX	1SLS-10-H110	SLS-110	15	TRTDTRG	Treatment Duration Target	48
	123	NRU	TX	1SLS-10-H110	SLS-110	16	TRTDMAX	Treatment Duration Max	48.5
	123	NRU	TX	1SLS-10-H110	SLS-110	17	TRTDU	Treatment Duration Unit	HOURS
	123	NRU	TX	1SLS-10-H110	SLS-110	18	INCBTMP	Incubation Temperature	37
	123	NRU	TX	1SLS-10-H110	SLS-110	19	INCBTMPU	Incubation Temperature Unit	C
	123	NRU	TX	1SLS-10-H110	SLS-110	20	~~MEDIA~~	~~Composition of Media~~	~~Sartorius HEK293~~
	123	NRU	TX	1SLS-10-H110	SLS-110	21	HUMID	Atmospheric Relative Humidity Percent	90
	123	NRU	TX	1SLS-10-H110	SLS-110	22	ATMCO2	Atmospheric CO2 Percent	5
	123	NRU	TX	1SLS-10-H110	SLS-110	23	SPTOBID	Sponsor defined tobacco identifier	CIG01a
	123	NRU	TX	1SLS-10-H110	SLS-110	24	EXPTYP	Exposure Type	Air Liquid Interface
	123	NRU	TX	1SLS-10-H110	SLS-110	25	SAMTYP	Sample Type	Whole Smoke Conditioned Media
...
	123	NRU	TX2	SLS-	110	SLS-110	1	PLATENUM	Plate number	2
	123	NRU	TX2	SLS-	110	SLS-110	2	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX2	SLS-	110	SLS-110	3	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX2	SLS-	110	SLS-110	4	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX2	SLS-	110	SLS-110	5	ITVCONC	intervention concentration	200
	123	NRU	TX2	SLS-	110	SLS-110	6	ITVCONCU	intervention unit	ug/ml
	123	NRU	TX2	SLS-	110	SLS-110	7	STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU	TX2	SLS-	110	SLS-110	8	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
	123	NRU	TX2	SLS-	110	SLS-110	9	DUREFID	Smoking Regime	Medium Intensity Regimen
	123	NRU	TX2	SLS-	110	SLS-110	10	RUN	Assay run number	1
	123	NRU	TX2	SLS-	110	SLS-110	11	SMPLID	Sample ID	030001
	123	NRU	TX2	SLS-	110	SLS-110	12	SMKEXSYS	Smoke Exposure System	Cambridge filter pad, eluted in DMSO
	123	NRU	TX2	SLS-	110	SLS-110	13	REPNUM	Replicate Number	1
	123	NRU	TX2	SLS-	110	SLS-110	14	TRTDMIN	Treatment Duration Min	47.5
	123	NRU	TX	2-10-H	SLS-110	SLS-110	15	TRTDTRG	Treatment Duration Target	48
	123	NRU	TX2	SLS-	110	SLS-110	16	TRTDMAX	Treatment Duration Max	48.5
	123	NRU	TX2	SLS-	110	SLS-110	17	TRTDU	Treatment Duration Unit	HOURS
	123	NRU	TX2	SLS-	110	SLS-110	18	INCBTMP	Incubation Temperature	37
	123	NRU	TX	2SLS-10-H110	SLS-110	19	INCBTMPU	Incubation Temperature Unit	C
	123	NRU	TX	2SLS-10-H110	SLS-110	20	~~MEDIA~~	~~Composition of Media~~	~~Sartorius HEK293~~
	123	NRU	TX	2SLS-10-H110	SLS-110	21	HUMID	Atmospheric Relative Humidity Percent	90
	123	NRU	TX	2SLS-10-H110	SLS-110	22	ATMCO2	Atmospheric CO2 Percent	5
	123	NRU	TX2	SLS-	110	SLS-110	23	SPTOBID	Sponsor defined tobacco identifier	CIG01a
	123	NRU	TX2	SLS-	110	SLS-110	24	EXPTYP	Exposure Type	Air Liquid Interface
	123	NRU	TX2	SLS-	110	SLS-110	25	SAMTYP	Sample Type	Whole Smoke Conditioned Media
...

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title	ei.xpt Entity Identifiers (dm-like)

Row	STUDYID	ASSAYID	DOMAIN	SETCD (from TX)	EUID	OBUID	RUNID
1	123	NRU	OU	CSC-50	1-B-3	1-B-3	1
2	123	NRU	OU	CSC-50	1-C-3	1-C-3	1
3	123	NRU	OU	SLS-110	1-G-10	1-G-10	1
4	123	NRU	OU	SLS-110	2-G-10	2-G-10	1

ou.xpt. Observational and Experimental Units domain

Experimental unit - The unit to which the treatment is applied, eg. Test tube

Observational unit - The unit on which the response is measured. (This may not be the same as the experimental unit.)

Row	STUDYID	ASSAYID	DOMAIN	SETCD (in TX)	EUID	OBUID
1	123	MLA	OU	A1	4_-S9_C31.3_B	VC1
2	123	MLA	OU	A1	4_-S9_C31.3_B	VC2
3	123	MLA	OU	A1	4_-S9_C31.3_B	VC3
4	123	MLA	OU	A1	4_-S9_C31.3_B	TFT1
5	123	MLA	OU	A1	4_-S9_C31.3_B	TFT2
6	123	MLA	OU	A1	4_-S9_C31.3_B	TFT3
7	123	MLA	OU	A2	4_-S9_C500_B	VC1
8	123	MLA	OU	A2	4_-S9_C500_B	VC2
9	123	MLA	OU	A2	4_-S9_C500_B	VC3
10	123	MLA	OU	A2	4_-S9_C500_B	TFT1
11	123	MLA	OU	A2	4_-S9_C500_B	TFT2
12	123	MLA	OU	A2	4_-S9_C500_B	TFT3

Entity IDs are unique within the assay (and a study can have many assays)
Replicates vs. Run
- need planned (ei.xpt) separate from the actual (gt.xpt)
- If tests run at the same time, they are replicates and are assigned the same RUNID
- If tests are run at separate times, they are runs and the RUNIDs are distinct
Different runs would be expected to have different ENID and GTDTC values. In ei.xpt, these are distinguished by different RUNID values.
Entities that are replicates of each other would be expected to
- have different ENID values
- be in the same trial set (SETCD values)
- have the same RUNID values

In this example, SETCD and ENID are the same value.

Row

STUDYID

ASSAYID

DOMAIN

ENID (Entity ID)

SETCD (from TX)

RUNID

123

NRU

EI

1-2-B

1

123

NRU

EI

1-2-E?

1-2-E

2

2-11-G

1

2-11-F?

2-11-F

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Versions Compared

Old Version 44

New Version 45

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, vehicle control, solvent control)

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

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

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