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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

B2B

Trial = Sample preps (creating test material) vs.

Replicates = different plates

Col/Row = testing of an individual sample multiple times

Preparing test material ( different materials in different flasks,

Applying test material to plate/well

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXSEQ	TXPARMCD	TXPARM	TXVAL	Definitions
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	PRODUCTPRODUCT
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
7	123	NRU	TX	1-1-A	CSC-10		STRAIN	Strain/Substrain	Salmonella enterica enterica
8	123	NRU	TX	1-1-A	CSC-10		REGIME	Smoking Regime	Traditional combustible
9	123	NRU	TX	1-1-A	CSC-10		RUN	Assay run number	1
10	~~123~~	~~NRU~~	TX	~~1-1-A~~	~~CSC-10~~		~~PORT~~	~~Port ID~~	1
11	123	NRU	TX	1-1-A	CSC-10		SMPLID	Sample ID	030001
12	123	NRU	TX	1-1-A	CSC-10		SMKFRC	Smoke Fraction	A
13	123	NRU	TX	1-1-A	CSC-10		REPNUM	Replicate Number1	1
	123	NRU	TX	1-1-	A	CSC-10	PLATENUM. (e.g., 1 or 2)	1	1		SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
	123	NRU	TX	1-1-	A	CSC-10			DUREFID	Smoke Regimen	Medium Intensity Regimen
1	123	NRU	TX	1-1-B	CSC-10		PLATENUM. (e.g., 1 or 2)	1	1
2	123	NRU	TX	1-1-B	CSC-10		WELLNUM (e.g., 1-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		INTRVN	name of the intervention article	Cigarette Smoke Condensate
4	123	NRU	TX	1-1-B	CSC-10		ITVTYPE (CT e.g, Product, positive control, negative control)	type of intervention article	PRODUCT
5	123	NRU	TX	1-1-B	CSC-10		ITVCONC	intervention concentration	10
6	123	NRU	TX	1-1-B	CSC-10		ITVCONCU	intervention unit	ug/ml
7	123	NRU	TX	1-1-B	CSC-10		STRAIN	Strain/Substrain	Salmonella enterica enterica
8	123	NRU	TX	1-1-B	CSC-10		REGIME	Smoking Regime	Traditional combustible
9	123	NRU	TX	1-1-B	CSC-10		RUN (Test Result, use to analyze for biases, group of replicates over time frame and lab condition)RUN	Assay run number	1	Identified at result level,
10	~~123~~	~~NRU~~	TX	~~1-1-B~~	~~CSC-10~~		~~PORT~~	~~Port ID~~	1
11	123	NRU	TX	1-1-B	CSC-10		SMPLID	Sample ID	030001
12	123	NRU	TX	1-1-B	CSC-10		~~SMKFRC~~	~~Smoke Fraction~~	A
							SMKEXSYS	Smoke Exposure System	Cambridge filter pad, eluted in DMSO
13	123	NRU	TX	1-1-B	CSC-10		REPNUM (Replicated independent separate samples prepared and run the same vs. duplicates across wells, running the same replicate across many wells)REPNUM	Replicate Number	1


14	123	NRU	TX	1-1-B	CSC-10		ITVCONC	intervention concentration	10
15	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

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Old Version 28

New Version 29

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)

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

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

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

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