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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

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

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Versions Compared

Old Version 30

New Version 31

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)