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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.
Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level
Assumption: SPDEVID (sponsor defined device identifier), and Test System should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)
Assumption: SPDEVID and DUREFID should only be in TX (with the same value for all sets if there is only one device used)
Assumption: SPDEVID (sponsor defined device identifier) should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)
Do we need both SPDEVID AND DUREFID?
What are good values (realistic) for "SET"?
Check Essential Data list

A1:

A2:

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	MNvit	TX	A1 (table 1, row 1, ST exposure with S9)	ST+S9C0	1	TESTSYS	Test system	TK6 Lymphoblastoid Suspension Cells
2	123	MNvit	TX	A1	ST+S9C0	2	METACT	Metabolic Activation (this is the type of activation used)	+S9
3	123	MNvit	TX	A1	ST+S9C0	3	METACTFL	Y/N presence of metabolic activation (this indicates that metabolic activation was used)	Y
4	123	MNvit	TX	A1	ST+S9C0	4	TRTDMIN	Treatment Duration Minimum	3
5	123	MNvit	TX	A1	ST+S9C0	5	TRTDTRG	Treatment Duration Target	3.5
6	123	MNvit	TX	A1	ST+S9C0	6	TRTDMAX	Treatment Duration Maximum	4
7	123	MNvit	TX	A1	ST+S9C0	7	TRTDU	Treatment Duration Unit	HOURS
8	123	MNvit	TX	A1	ST+S9C0	8	RCVDMIN	Recovery Duration Minimum	23.5
9	123	MNvit	TX	A1	ST+S9C0	9	RCVDTRG	Recovery Duration Target	24
10	123	MNvit	TX	A1	ST+S9C0	10	RCVDMAX	Recovery Duration Maximum	24.5
11	123	MNvit	TX	A1	ST+S9C0	11	RCVDU	Recovery Duration Unit	HOURS
12	123	MNvit	TX	A1	ST+S9C0	12	INCBTMP	Incubation Temperature	37
13	123	MNvit	TX	A1	ST+S9C0	13	INCBTMPU	Incubation Temperature Unit	C
14	123	MNvit	TX	A1	ST+S9C0	14	HUMID	Atmospheric Relative Humidity Percent	50
15	123	MNvit	TX	A1	ST+S9C0	15	ATMCO2	Atmospheric CO2 Percent	5
16	123	MNvit	TX	A1	ST+S9C0	16	SPTOBID	Sponsor defined tobacco identifier	CIG01a
17	123	MNvit	TX	A1	ST+S9C0	17	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
18	123	MNvit	TX	A1	ST+S9C0	18	SAMTYP	Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical)	Total Particulate Matter in DMSO
19	123	MNvit	TX	A1	ST+S9C0	19	INTRVN	Name of the Intervention Article can be: Tobacco ProdA, Bleomycin (positive control) or Cyclophosphamid A (positive control)	Tobacco ProdA
20	123	MNvit	TX	A1	ST+S9C0	20	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Negative Control
21	123	MNvit	TX	A1	ST+S9C0	21	ITVCONC	Concentration of intervention article	0
22	123	MNvit	TX	A1	ST+S9C0	22	ITVCONCU	Concentration Unit	ug/ml
23	123	MNvit	TX	A1	ST+S9C0	23	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
24	123	MNvit	TX	A1	ST+S9C0	24	DUREFID	Smoke Regimen	Medium Intensity Regimen
25	123	MNvit	TX	A2 (table 1, row 2, ST exposure with S9 at concentration 1250)	ST+S9-1250	1	TESTSYS	Test system	TK6 Lymphoblastoid Suspension Cells
26	123	MNvit	TX	A2	ST+S9-1250	2	METACT	Metabolic Activation (this is the type of activation used)	+S9
27	123	MNvit	TX	A2	ST+S9-1250	3	METACTFL	Y/N presence of metabolic activation (this indicates that metabolic activation was used)	Y
28	123	MNvit	TX	A2	ST+S9-1250	4	TRTDMIN	Treatment Duration Minimum	3
29	123	MNvit	TX	A2	ST+S9-1250	5	TRTDTRG	Treatment Duration Target	3.5
30	123	MNvit	TX	A2	ST+S9-1250	6	TRTDMAX	Treatment Duration Maximum	4
31	123	MNvit	TX	A2	ST+S9-1250	7	TRTDU	Treatment Duration Unit	HOURS
32	123	MNvit	TX	A2	ST+S9-1250	8	RCVDMIN	Recovery Duration Minimum	23.5
33	123	MNvit	TX	A2	ST+S9-1250	9	RCVDTRG	Recovery Duration Target	24
34	123	MNvit	TX	A2	ST+S9-1250	10	RCVDMAX	Recovery Duration Maximum	24.5
35	123	MNvit	TX	A2	ST+S9-1250	11	RCVDU	Recovery Duration Unit	HOURS
36	123	MNvit	TX	A2	ST+S9-1250	12	INCBTMP	Incubation Temperature	37
37	123	MNvit	TX	A2	ST+S9-1250	13	INCBTMPU	Incubation Temperature Unit	C
38	123	MNvit	TX	A2	ST+S9-1250	14	HUMID	Atmospheric Relative Humidity Percent	50
39	123	MNvit	TX	A2	ST+S9-1250	15	ATMCO2	Atmospheric CO2 Percent	5
40	123	MNvit	TX	A2	ST+S9-1250	16	SPTOBID	Sponsor defined tobacco identifier	CIG01a
41	123	MNvit	TX	A2	ST+S9-1250	17	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
42	123	MNvit	TX	A2	ST+S9-1250	18	SAMTYP	Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical)	Total Particulate Matter in DMSO
43	123	MNvit	TX	A2	ST+S9-1250	19	INTRVN	Name of the Intervention Articlecan be:	Tobacco ProdA, Bleomycin (positive control) or Cyclophosphamid A (positive control)
44	123	MNvit	TX	A2	ST+S9-1250	20	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Product
45	123	MNvit	TX	A2	ST+S9-1250	21	ITVCONC	Concentration of intervention article	1250
46	123	MNvit	TX	A2	ST+S9-1250	22	ITVCONCU	Concentration Unit	ug/ml
47	123	MNvit	TX	A2	ST+S9-1250	23	SPDEVID	Sponsor defined device identifier	PUFFMASTER2023
48	123	MNvit	TX	A2	ST+S9-1250	24	DUREFID	Smoke Regimen	High Intensity Regimen
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title	du.xpt smoke regimen definition (a findings domain for device in-use properties)

We use DU for smoking regimen. Note that a separate DI dataset will be needed to show identifying parameters of the "PUFFMASTER3K" smoking machine

Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).
Smoking regimen is represented in --REFID (we made up a value of "Medium Intensity Regimen"; we can update with something realistic)
The smoking regimen is carried out by the smoking machine/device shown in SPDEVID, Sponsor defined device identifier, "PUFFMASTER3K"

du.xpt

Row	STUDYID	DOMAIN	SPDEVID	DUSEQ	DUREFID	DUGRPID	DUTESTCD	DUTEST	DUORRES	DUORRESU	DUSTRESC	DUSTRESN	DUSTRESU
1	123	DU	PUFFMASTER3K	1	Medium Intensity Regimen		PUFFPROF	Puff Profile	SQUARE		SQUARE
2	123	DU	PUFFMASTER3K	2	Medium Intensity Regimen		PUFFDUR	Puff Duration	1.25	sec	1.25	1.25	sec
3	123	DU	PUFFMASTER3K	3	Medium Intensity Regimen		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
4	123	DU	PUFFMASTER3K	4	Medium Intensity Regimen		PUFFBLCK	Puff Block	25	%	25	25	%
5	123	DU	PUFFMASTER3K	5	Medium Intensity Regimen		NUMPUFF	Total Number of Puffs	200	PUFF	200	200	PUFF
6	123	DU	PUFFMASTER3K	6	Medium Intensity Regimen		PUFFVOL	Puff Volume	10	mL	10	10	mL
7	123	DU	PUFFMASTER3K	7	Medium Intensity Regimen		PUFFRNG	Puff Range	100-200		100-200
8	123	DU	PUFFMASTER3K	8	Medium Intensity Regimen	1	PUFFPAUS	Puff Pause	60	s	60	60	s
9	123	DU	PUFFMASTER3K	9	Medium Intensity Regimen	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF
10	123	DU	PUFFMASTER2023	1	Canadian Intense Regime		PUFFPROF	Puff Profile	SQUARE		SQUARE
11	123	DU	PUFFMASTER2023	2	Canadian Intense Regime		PUFFDUR	Puff Duration	2.00	sec	2.00	2.00	sec
12	123	DU	PUFFMASTER2023	3	Canadian Intense Regime		PUFFINT	Puff Interval	4	PUFF/min	4	4	PUFF/min
13	123	DU	PUFFMASTER2023	4	Canadian Intense Regime		PUFFBLCK	Puff Block	0	%	0	0	%
14	123	DU	PUFFMASTER2023	5	Canadian Intense Regime		NUMPUFF	Total Number of Puffs	200	PUFF	200	200	PUFF
15	123	DU	PUFFMASTER2023	6	Canadian Intense Regime		PUFFVOL	Puff Volume	10	mL	10	10	mL
16	123	DU	PUFFMASTER2023	7	Canadian Intense Regime		PUFFRNG	Puff Range	100-200		100-200
17	123	DU	PUFFMASTER2023	8	Canadian Intense Regime	1	PUFFPAUS	Puff Pause	60	s	60	60	s
18	123	DU	PUFFMASTER2023	9	Canadian Intense Regime	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF

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