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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

A1:

A2:

Row	STUDYID	ASSAYID	DOMAIN	SETCD	TXSEQ	TXPARMCD	TXPARM	TXVAL
	123	MNvit	TX	A1 (table 1, row 1, ST exposure with S9)		METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
						METACTFL	Y/N presence of metabolic activation
	123	MNvit	TX	A1		TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)	3
	123	MNvit	TX	A1		TRTDRTOL	Treatment Duration Tolerance
	123	MNvit	TX	A1		TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	MNvit	TX	A1		INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	Tobacco ProdA
	123	MNvit	TX	A1		ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Product
	123	MNvit	TX	A1		ITVCONC	Concentration of intervention article	0
	123	MNvit	TX	A1		ITVCONCU	Concentration Unit	ug/ml
	123	MNvit	TS	A1	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
	123	MNvit	TS	A1	DUREFID	Smoke Regimen	Medium Intensity Regimen
	123	MNvit	TX	A2 (table 1, row 2)		METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
	123	MNvit	TX	A2		TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)	3
	123	MNvit	TX	A2		TRTDRTOL	Treatment Duration Tolerance
	123	MNvit	TX	A2		TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	MNvit	TX	A2		INTRVN	name of the intervention article	Tobacco ProdA
	123	MNvit	TX	A2		ITVTYPE	type of intervention article	Product
	123	MNvit	TX	A2		ITVCONC	Concentration of i a	1250
	123	MNvit	TX	A2		ITVCONCU	Concentration Unit	ug/ml
	123	MNvit	TS	A2	SPDEVID	Sponsor defined device identifier	PUFFMASTER2023
	123	MNvit	TS	A2	DUREFID	Smoke Regimen	High Intensity Regimen
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title	du.xpt (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, but is currently not shown for brevity.

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"
Do we need both SPDEVID AND DUREFID?

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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title	di.xpt (a study reference domain for unique device identification)

di.xpt (copied v1.0 of medical devices IG)

This example is a copy of Example 1 from di.xpt in SDTMIG-MD v1.0 but with values for SPDEVID and DIVAL revised slightly.
Should I remove the FDA UDI (row 5) unless CTP has or plans to establish UDI values?

Example 1
This shows records for two devices where the sponsor felt that the type, manufacturer, model number, and serial number were necessary for unique identification. In addition, there was a post-marketing UDI identifier available for the first device.

Rows 1-5 show the records for a device given a SPDEVID of ABC001
Rows 5-8 show the records for a device given a SPDEVID of ABC999

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	2011-001	DI	PUFFMASTER3K	1	DEVTYPETYPE	Device Type	MRIAll values in DIVAL corresponding to DEVTYPE in all examples need to be updated to conform with FDA Product Classification codes
2	2011-001	DI	PUFFMASTER3K	2	MANUF	Manufacturer	Acme Machines
3	2011-001	DI	PUFFMASTER3K	3	MODEL	Model Number	45-JFI
4	2011-001	DI	PUFFMASTER3K	4	SERIAL	Serial Number	456789132-AXQ
5	2011-001	DI	PUFFMASTER3K	5	FDAUDI	FDA Unique Device Identifier	456789123xyz
6	2015-001	DI	PUFFMASTER2023	1	DEVTYPETYPE	Device Type	MRI
7	2015-001	DI	PUFFMASTER2023	2	MANUF	Manufacturer	Acme Machines
8	2015-001	DI	PUFFMASTER2023	3	MODEL	Model Number	62-PLC
9	2015-001	DI	PUFFMASTER2023	4	SERIAL	Serial Number	215964564-NFS

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title	gt.xpt (similar to LB)

A1:

A2:

Row	STUDYID	ASSAYID	DOMAIN	TXSETCD	GTSEQ	GTTESTCD	GTTEST	GTCELLEV (cells evaluated)	GTORRES	GTORRESU	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC
1	123	MNvit	GT	A1	1	RICC	Relative Increase in Cell Count	0	0	%	0	0	%	2022-05-25
2	123	MNvit	GT	A1	2	RCC	Relative Cell Count	154	0	%	0	0	%	2022-05-25
3	123	MNvit	GT	A1	3	RPD	Relative Population Doubling	154	0	%	0	0	%	2022-05-25
4	123	MNvit	GT	A1	4	MNCELLS	Micronucleated Cells	2205	15	Cells	15	15	Cells	2022-05-25
5	123	MNvit	GT	A1	5	MNCELLS	Micronucleated Cells	2474	13	Cells	13	13	Cells	2022-05-25
6	123	MNvit	GT	A1	6	MNCELLS	Micronucleated Cells	2758	17	Cells	17	17	Cells	2022-05-25
7	123	MNvit	GT	A1	7	MNCELLS	Micronucleated Cells	2669	12	Cells	12	12	Cells	2022-05-25
8	123	MNvit	GT	A1	8	AVGREL	Average Relative MN Frequency		0.57	%	0.57	0.57	%	2022-05-25
9	123	MNvit	GT	A2	1	RICC	Relative Increase in Cell Count	134	15.7	%	15.7	15.7	%	2022-05-25
10	123	MNvit	GT	A2	2	RCC	Relative Cell Count	134	13.0	%	13.0	13.0	%	2022-05-25
11	123	MNvit	GT	A2	3	RPD	Relative Population Doubling	134	7.9	%	7.9	7.9	%	2022-05-25
12	123	MNvit	GT	A2	4	MNCELLS	Micronucleated Cells	3266	20	Cells	20	20	Cells	2022-05-25
13	123	MNvit	GT	A2	5	MNCELLS	Micronucleated Cells	2190	17	Cells	17	17	Cells	2022-05-25
14	123	MNvit	GT	A2	6	MNCELLS	Micronucleated Cells	2758	13	Cells	13	13	Cells	2022-05-25
15	123	MNvit	GT	A2	7	MNCELLS	Micronucleated Cells	2714	21	Cells	21	21	Cells	2022-05-25
16	123	MNvit	GT	A2	8	AVGREL	Average Relative MN Frequency		0.66	%	0.66	0.66	%	2022-05-25
...

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Key

SET (what sponsor calls it)