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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

SLS10PLATENUMPlate number10-HPOSITIVE CONTROL110200110ug/ml11024EXPTYPAir Liquid Interface11025...101010-1010ITVCONC20010ITVCONCU...

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	1-2-B (plate-col-row in the 96-well plate)	CSC-50 (through SLS-200)	1	PLATENUM. (e.g., 1 or 2)	1	1
2	123	NRU	TX	1-2-B	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	TX	1-2-B	CSC-50	4	ITVTYPE (CT e.g, Product, positive control, negative control, vehicle control, solvent control)	type of intervention article	PRODUCT
	123	NRU	TX	1-2-B	CSC-50	5	ITVCONC	intervention concentration	50
	123	NRU	TX	1-2-B	CSC-50	6	ITVCONCU	intervention unit	ug/ml
	123	NRU	TX	1-2-B	CSC-50	7	STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU	TX	1-2-B	CSC-50	8	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
	123	NRU	TX	1-2-B	CSC-50	9	DUREFID	Smoking Regime	Medium Intensity Regimen
	123	NRU	TX	1-2-B	CSC-50	10	RUN	Assay run number	1
	123	NRU	TX	1-2-B	CSC-50	11	SMPLID	Sample ID	030001
	123	NRU	TX	1-2-B	CSC-50	12	SMKEXSYS	Smoke Exposure System	Cambridge filter pad, eluted in DMSO
	123	NRU	TX	1-2-B	CSC-50	13	REPNUM	Replicate Number	1
	123	NRU	TX	1-2-B	CSC-50	14	TRTDMIN	Treatment Duration Min	47.5
	123	NRU	TX	1-2-B	CSC-50	15	TRTDTRG	Treatment Duration Target	48
	123	NRU	TX	1-2-B	CSC-50	16	TRTDMAX	Treatment Duration Max	48.5
	123	NRU	TX	1-2-B	CSC-50	17	TRTDU	Treatment Duration Unit	HOURS
	123	NRU	TX	1-2-B	CSC-50	18	INCBTMP	Incubation Temperature	37
	123	NRU	TX	1-2-B	CSC-50	19	INCBTMPU	Incubation Temperature Unit	C
	~~123~~	~~NRU~~	TX	~~1-2-B~~	~~CSC-50~~	20	~~MEDIA~~	~~Composition of Media~~	~~Sartorius HEK293~~
	123	NRU	TX	1-2-B	CSC-50	21	HUMID	Atmospheric Relative Humidity Percent	90
	123	NRU	TX	1-2-B	CSC-50	22	ATMCO2	Atmospheric CO2 Percent	5
	123	NRU	TX	1-2-B	CSC-50	23	SPTOBID	Sponsor defined tobacco identifier	CIG01a
	123	NRU	TX	1-2-B	CSC-50	24	EXPTYP	Exposure Type	Air Liquid Interface
	123	NRU	TX	1-2-B	CSC-50	25	SAMTYP	Sample Type	Whole Smoke Conditioned Media
	123	NRU	TX	1-2-C	CSC-1050	1	PLATENUM. (e.g., 1 or 2)	1	1
	123	NRU	TX	1-2-C	CSC-1050	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-1050	3	INTRVN	name of the intervention article	Cigarette Smoke Condensate
	123	NRU	TX	1-2-C	CSC-1050	4	ITVTYPE (CT e.g, Product, positive control, negative control)	type of intervention article	PRODUCT
	123	NRU	TX	1-2-C	CSC-1050	5	ITVCONC	intervention concentration	10
	123	NRU	TX	1-2-C	CSC-1050	6	ITVCONCU	intervention unit	ug/ml
	123	NRU	TX	1-2-C	CSC-1050	7	STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU	TX	1-2-C	CSC-1050	8	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
	123	NRU	TX	1-2-C	CSC-1050	9	DUREFID	Smoking Regime	Medium Intensity Regimen
	123	NRU	TX	1-2-C	CSC-1050	10	RUN	Assay run number	1
	123	NRU	TX	1-2-C	CSC-1050	11	SMPLID	Sample ID	030001
	123	NRU	TX	1-2-C	CSC-1050	12	SMKEXSYS	Smoke Exposure System	Cambridge filter pad, eluted in DMSO
	123	NRU	TX	1-2-C	CSC-1050	13	REPNUM	Replicate Number	1
	123	NRU	TX	1-2-C	CSC-1050	14	TRTDMIN	Treatment Duration Min	47.5
	123	NRU	TX	1-2-C	CSC-1050	15	TRTDTRG	Treatment Duration Target	48
	123	NRU	TX	1-2-C	CSC-1050	16	TRTDMAX	Treatment Duration Max	48.5
	123	NRU	TX	1-2-C	CSC-1050	17	TRTDU	Treatment Duration Unit	HOURS
	123	NRU	TX	1-2-C	CSC-1050	18	INCBTMP	Incubation Temperature	37
	123	NRU	TX	1-2-C	CSC-1050	19	INCBTMPU	Incubation Temperature Unit	C
	~~123~~	~~NRU~~	TX	~~1-2-C~~	CSC-10		20	~~MEDIA~~	~~Composition of Media~~	~~Sartorius HEK293~~
	123	NRU	TX	1-2-C	CSC-1050	21	HUMID	Atmospheric Relative Humidity Percent	90
	123	NRU	TX	1-2-C	CSC-1050	22	ATMCO2	Atmospheric CO2 Percent	5
	123	NRU	TX	1-2-C	CSC-1050	23	SPTOBID	Sponsor defined tobacco identifier	CIG01a
	...	...	123	NRU	TX	1-10-H	CSC-	50	24	EXPTYP	1	Exposure Type	Air Liquid Interface
	123	123	NRU	TX	1-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	CSC-50	25	SAMTYP	Sample Type	Whole Smoke Conditioned Media
...				...
	123	NRU	TX	1-10-H	SLS-10110	1	INTRVN	name of the intervention article	PLATENUM	Plate number	1 sodium laurel sulfate
	123	NRU	TX	1-10-H	SLS-10110	ITVTYPE	type of intervention article	2	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	1-10-H	SLS-110	3	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	1-10-H	SLS-110	4	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	1-10-H	SLS-110	5	ITVCONC	intervention concentration	200
	123	NRU	TX	1-10-H	SLS-110	6	ITVCONCU	intervention unit	ug/ml
	123	NRU	TX	1-10-H	SLS-110	7	STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU	TX	1-10-H	SLS-110	8	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
	123	NRU	TX	1-10-H	SLS-110	9	DUREFID	Smoking Regime	Medium Intensity Regimen
	123	NRU	TX	1-10-H	SLS-110	10	RUN	Assay run number	1
	123	NRU	TX	1-10-H	SLS-110	11	SMPLID	Sample ID	030001
	123	NRU	TX	1-10-H	SLS-110	12	SMKEXSYS	Smoke Exposure System	Cambridge filter pad, eluted in DMSO
	123	NRU	TX	1-10-H	SLS-110	13	REPNUM	Replicate Number	1
	123	NRU	TX	1-10-H	SLS-110	14	TRTDMIN	Treatment Duration Min	47.5
	123	NRU	TX	1-10-H	SLS-110	15	TRTDTRG	Treatment Duration Target	48
	123	NRU	TX	1-10-H	SLS-110	16	TRTDMAX	Treatment Duration Max	48.5
	123	NRU	TX	1-10-H	SLS-110	17	TRTDU	Treatment Duration Unit	HOURS
	123	NRU	TX	1-10-H	SLS-110	18	INCBTMP	Incubation Temperature	37
	123	NRU	TX	1-10-H	SLS-110	19	INCBTMPU	Incubation Temperature Unit	C
	123	NRU	TX	1-10-H	SLS-110	20	~~MEDIA~~	~~Composition of Media~~	~~Sartorius HEK293~~
	123	NRU	TX	1-10-H	SLS-110	21	HUMID	Atmospheric Relative Humidity Percent	90
	123	NRU	TX	1-10-H	SLS-110	22	ATMCO2	Atmospheric CO2 Percent	5
	123	NRU	TX	1-10-H	SLS-110	23	SPTOBID	Sponsor defined tobacco identifier	CIG01a
	123	NRU	TX	1-10-H	SLS-110	24	EXPTYP	Exposure Type	Air Liquid Interface
	123	NRU	TX	1-10-H	SLS-110	25	SAMTYP	Sample Type	Whole Smoke Conditioned Media
...				...
	123	NRU	TX	2-10-H	SLS-110	1	PLATENUM	Plate number	2
	123	NRU	TX	2-10-H	SLS-110	2	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	2-10-H	SLS-110	3	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	2-10-H	SLS-110	4	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	2-10-H	SLS-110	5	ITVCONC	intervention concentration	200
	123	NRU	TX	2-10-H	SLS-110	6	ITVCONCU	intervention unit	ug/ml
	123	NRU	TX	2-10-H	SLS-110	7	STRAIN	Strain/Substrain	Salmonella enterica enterica
	123	NRU	TX	2-10-H	SLS-110	8	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
	123	NRU	TX	2-10-H	SLS-110	9	DUREFID	Smoking Regime	Medium Intensity Regimen
	123	NRU	TX	2-10-H	SLS-110	10	RUN	Assay run number	1
	123	NRU	TX	2-10-H	SLS-110	11	SMPLID	Sample ID	030001
	123	NRU	TX	2-10-H	SLS-110	12	SMKEXSYS	Smoke Exposure System	Cambridge filter pad, eluted in DMSO
	123	NRU	TX	2-10-H	SLS-110	13	REPNUM	Replicate Number	1
	123	NRU	TX	2-10-H	SLS-110	14	TRTDMIN	Treatment Duration Min	47.5
	123	NRU	TX	2-10-H	SLS-110	15	TRTDTRG	Treatment Duration Target	48
	123	NRU	TX	2-10-H	SLS-	110	16	ITVCONC	intervention concentration	TRTDMAX	Treatment Duration Max	48.5
	123	NRU	TX	2-10-H	SLS-	110	17	ITVCONCU	intervention unit	TRTDU	Treatment Duration Unit	HOURS
	123	NRU	TX	2-10-H	SLS-	110	18	INCBTMP	Exposure Type	Incubation Temperature	37
	123	NRU	TX	2-10-H	SLS-	110	19	SAMTYP	Sample Type	Whole Smoke Conditioned Media	...	INCBTMPU	Incubation Temperature Unit	C
	123	NRU	TX	2-10-H	SLS-	110	20	PLATENUM	Plate number	~~MEDIA~~	~~Composition of Media~~	~~Sartorius HEK293~~2
	123	NRU	TX	2-10-H	SLS-	110	21	WELLNUM	Number representing the location of the well in the 96-well plate	HUMID	Atmospheric Relative Humidity Percent	9010-H
	123	NRU	TX	2-10-H	SLS-	110	22	INTRVN	name of the intervention article	ATMCO2	Atmospheric CO2 Percent	5sodium laurel sulfate
	123	NRU	TX	2-10-H	SLS	-110	23	SPTOBID	Sponsor defined tobacco identifier	CIG01a	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	2-10-H	SLS-	110	24	EXPTYP	intervention concentration	Exposure Type	Air Liquid Interface
	123	NRU	TX	2-10-H	SLS-	110	25	intervention unit	ug/ml	SAMTYP	Sample Type	Whole Smoke Conditioned Media
...

PLATEID (Plate

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title	ei.xpt Entity Identifiers (dm-like)

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

Row	STUDYID	ASSAYID	DOMAIN	ENID (Entity

ID)

SETCD (from TX)

RUNID

REPLCTID

(Replicate Number)

ID)

COLID

(Column number)

ROWID (Row number)

SETCD (from TX)	RUNID
	123	NRU	EI	1-2-B	1-2-B	1
	123	NRU	EI	1-

8-3 (plate - col- row)

2-E?	1-2-E	2
				2-11-G	2-11-G	1
				2-11-F?	2-11-F	2

123NRUEI1-3-B1-3-B1

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Versions Compared

Old Version 39

New Version 40

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)