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:

Row	STUDYID	ASSAYID	DOMAIN	SETCD	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	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
...

...

Page tree

Versions Compared

Old Version 45

New Version 46

Key

SET (what sponsor calls it)