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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
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 (what sponsor calls it, more meaningful label for Tables)	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	MNvit	TX	A1 (table 1, row 1, ST exposure with S9)	ST+S9C0	1	METACT	Metabolic Activation (this is the type of activation used)	+S9
2	123	MNvit	TX	A1	ST+S9C0	2	METACTFL	Y/N presence of metabolic activation (this indicates that metabolic activation was used)	Y
3	123	MNvit	TX	A1	ST+S9C0	3	TRTDMIN	Treatment Duration Minimum	3
4	123	MNvit	TX	A1	ST+S9C0	4	TRTDTRG	Treatment Duration Target	3.5
5	123	MNvit	TX	A1	ST+S9C0	5	TRTDMAX	Treatment Duration Maximum	4
6	123	MNvit	TX	A1	ST+S9C0	6	TRTDU	Treatment Duration Unit	HOURS
7	123	MNvit	TX	A1	ST+S9C0	7	RCVDMIN	Recovery Duration Minimum	23.5
8	123	MNvit	TX	A1	ST+S9C0	8	RCVDTRG	Recovery Duration Target	24
9	123	MNvit	TX	A1	ST+S9C0	9	RCVDMAX	Recovery Duration Maximum	24.5
10	123	MNvit	TX	A1	ST+S9C0	10	RCVDU	Recovery Duration Unit	HOURS
11	123	MNvit	TX	A1	ST+S9C0	11	INCBTMP	Incubation Temperature	37
12	123	MNvit	TX	A1	ST+S9C0	12	INCBTMPU	Incubation Temperature Unit	C
13	~~123~~	~~MNvit~~	TX	A1	~~ST+S9C0~~	13	~~MEDIA~~	~~Composition of Media~~	~~Sartorius HEK293~~
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
	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
18	123	MNvit	TX	A1	ST+S9C0	6	INTRVN	Name of the Intervention Article can be: Tobacco ProdA, Bleomycin (positive control) or Cyclophosphamid A (positive control)	Tobacco ProdA
19	123	MNvit	TX	A1	ST+S9C0	7	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Negative Control
20	123	MNvit	TX	A1	ST+S9C0	8	ITVCONC	Concentration of intervention article	0
21	123	MNvit	TX	A1	ST+S9C0	9	ITVCONCU	Concentration Unit	ug/ml
22	123	MNvit	TX	A1	ST+S9C0	10	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
23	123	MNvit	TX	A1	ST+S9C0	11	DUREFID	Smoke Regimen	Medium Intensity Regimen
24	~~123~~	~~MNvit~~	TX	A1	~~ST+S9C0~~	11	~~SMKEXSYS~~	~~Smoke Exposure System~~	~~Cambridge filter pad, eluted in DMSO~~
25	123	MNvit	TX	A2 (table 1, row 2, ST exposure with S9 at concentration 1250)	ST+S9-1250	1	METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
26	123	MNvit	TX	A2	ST+S9-1250	2	METACTFL	Y/N presence of metabolic activation (this indicates that metabolic activation was used)	Y
27	123	MNvit	TX	A2	ST+S9-1250	3	TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)	3
28	123	MNvit	TX	A2	ST+S9-1250	4	TRTDRTOL	Treatment Duration Tolerance
29	123	MNvit	TX	A2	ST+S9-1250	5	TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
30	123	MNvit	TX	A2	ST+S9-1250	6	INTRVN	name of the intervention article	Tobacco ProdA
31	123	MNvit	TX	A2	ST+S9-1250	7	ITVTYPE	type of intervention article	Product
32	123	MNvit	TX	A2	ST+S9-1250	8	ITVCONC	Concentration of i a	1250
33	123	MNvit	TX	A2	ST+S9-1250	9	ITVCONCU	Concentration Unit	ug/ml
34	123	MNvit	TX	A2	ST+S9-1250	10	SPDEVID	Sponsor defined device identifier	PUFFMASTER2023
35	123	MNvit	TX	A2	ST+S9-1250	11	DUREFID	Smoke Regimen	High Intensity Regimen
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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	REPNUM (perm

)PLATEID (Plate ID

)

COLID

ROWID (Row number)

(Column number)

123	MNvit	EI	1-8-3	A1	1	1

8

3

	123	MNvit	EI	2-8-3	A1	2	1
	123	MNvit	EI	3-7-1	A2	1	1
	123	MNvit	EI	2-7-1	A2	1	2

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Key

SET (what sponsor calls it, more meaningful label for Tables)