Page History

...

Expand

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:

TSTS

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXSEQ	TXPARMCD	TXPARM	TXVAL
	123	MNvit	TX	A1 (table 1, row 1, ST exposure with S9)	ST+S9	1	METACT	Metabolic Activation (this is the type of activation used)	+S9
	123	MNvit	TX	A1	ST+S9	2	METACTFL	Y/N presence of metabolic activation (this indicates that metabolic activation was used)	Y
	123	MNvit	TX	A1	ST+S9	3	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	ST+S9	4	TRTDRTOL	Treatment Duration Tolerance
	123	MNvit	TX	A1	ST+S9	5	TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	MNvit	TX	A1	ST+S9	6	INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	Tobacco ProdA
	123	MNvit	TX	A1	ST+S9	7	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Product
	123	MNvit	TX	A1	ST+S9	8	ITVCONC	Concentration of intervention article	0
	123	MNvit	TX	A1	ST+S9	9	ITVCONCU	Concentration Unit	ug/ml
	123	MNvit	TSTX	A1	ST+S9	10	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
	123	MNvit	TSTX	A1	ST+S9	11	DUREFID	Smoke Regimen	Medium Intensity Regimen
	123	MNvit	TX	A2 (table 1, row 2)		1	METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
	123	MNvit	TX	A2		2	METACTFL	Y/N presence of metabolic activation (this indicates that metabolic activation was used)	Y
	123	MNvit	TX	A2		3	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		4	TRTDRTOL	Treatment Duration Tolerance
	123	MNvit	TX	A2		5	TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	MNvit	TX	A2		6	INTRVN	name of the intervention article	Tobacco ProdA
	123	MNvit	TX	A2		7	ITVTYPE	type of intervention article	Product
	123	MNvit	TX	A2		8	ITVCONC	Concentration of i a	1250
	123	MNvit	TX	A2		9	ITVCONCU	Concentration Unit	ug/ml
	123	MNvit	TX	A2		10	SPDEVID	Sponsor defined device identifier	PUFFMASTER2023
	123	MNvit	TX	A2		11	DUREFID	Smoke Regimen	High Intensity Regimen
...

Expand

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, 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

...

Page tree

Versions Compared

Old Version 64

New Version 65

Key

SET (what sponsor calls it)