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title	ts.xpt (trial summary, study level parameters)

Assumption: Study can have more than one assay type
Assumption: ASSAYID value of ALL means it applies to all assays in the study

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	ALL	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
11	123	ALL	TS	1		STSTDTC	Study Start Date	2007-12-30
13	123	ALL	TS	1		STITLE	Study Title	Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14	123	ALL	TS	1		SNDIGVER	SEND Implementation Guide Version	Tobacco IMPLEMENTATION GUIDE VERSION 1.0
15	123	ALL	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-03-26
17	123	ALL	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
18	123	ALL	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
19	123	ALL	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
20	123	ALL	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
21	123	ALL	TS	1	1	TFCNTRY	Test Facility Country	USA
24	123	ALL	TS	1	1	STDIR	Study Director	Dr. R. Smith
25	123		TS	1		TRT	Investigational Therapy or Treatment	Drug A
26	123		TS	1	2	TRTV	Treatment Vehicle	Saline
27	123		TS	1	2	TRTVDESC	Treatment Vehicle Structured Description	100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}
28	123	ALL	TS	1		GLPFL	GLP Flag	Y
29	123	MNT	TS	1		ASTD	Assay Standard	OECD Test No. 487
30	123	MNT	TS	1		ASTDV	Assay Standard Version	2016-07-29
31	123	MNT	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
32	123	MNT	TS	1		SSSTYP	Study Sub Type	In Vitro Micronucleus
33	123	MNT	TS	1		SPECIES	Species	Homo Sapiens
34	123	MNT	TS	1		??	Test System?	TK6 Lymphoblastoid Suspension Cells
35	123	NRU	TS	1		ASTD	Assay Standard	NIH Publication No. 07-4519
36	123	NRU	TS	1		ASTDV	Assay Standard Version	2006-11
37	123	NRU	TS	1		SSTYP	Study Type
38	123	NRU	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake
39	123	NRU	TS	1		SPECIES	Species	Homo Sapiens
40	123	NRU	TS	1		??	Test System??	Normal Human Keratinocyte

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title	tx.xpt (trial sets)

Treatment Duration will be controlled? During CT definition/revies reviews will need to decide appropriate Treatment duration values; If not, what are best example values to show?For now, we just include good example values based on our experience

Row	STUDYID	ASSAYID	DOMAIN	SETCD	TXPARMCD	TXPARM	TXVAL
1	123	MNT	TX	A1	METACT	Metabolic ActivationActivation (should there be two parms? Presence, type)?	+S9
2	123	MNT	TX	A1	TRTDURTRTDRTRG	Treatment Duration	3 - 6	target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)	3

					TRTDRTOL	Treatment Duration Tolerance
					TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	TRTDURU	H
3	123	MNT	TX	A1	PRDCONC	Concentration of product	0
4	123	MNT	TX	A1	PRDCONCU	Concentration Unit	ug/ml
5	123	MNT	TX	A1	Product	Product Name
6	123	MNT	TX	A1		Smoking Regime
7	123	MNT	TX	A1		Smoke Fraction
	123	MNT	TX	A2	METACT	Metabolic Activation	+S9
	123	MNT	TX	A2	TRTDUR	Treatment Duration	Short Term
	123	MNT	TX	A2	PRDCONC	Concentration of product	1250
	123	MNT	TX	A2	PRDCONCU	Concentration Unit	ug/ml
	123	MNT	TX	A2	Product	Product Name
	123	MNT	TX	A2		Smoking Regime
	123	MNT	TX	A2		Smoke Fraction
	123	MNT	TX	B1	METACT	Metabolic Activation	-S9
	123	MNT	TX	B1	TRTDURTTRTDRTRG	Treatment Duration target	4 +/- 15m
					TRTDURTOLTRTDRTOL	Treatment Duration Tolerance	.25
??	123	MNT	TX	B1	TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	MNT	TX	B1	PRDCONC	Concentration of product	0
	123	MNT	TX	B1	PRDCONCU	Concentration Unit	ug/ml
	123	MNT	TX	B1	Product	Product Name
	123	MNT	TX	B1		Smoking Regime
	123	MNT	TX	B1		Smoke Fraction
	123	MNT	TX	C1	METACT	Metabolic Activation	-S9
	123	MNT	TX	C1	TRTDUR	Treatment Duration	24
??	123	MNT	TX	C1	TRTDURU	Treatment Duration Unit	H
	123	MNT	TX	C1	PRDCONC	Concentration of product	0
	123	MNT	TX	C1	PRDCONCU	Concentration Unit	ug/ml
	123	MNT	TX	C1	Product	Product Name
	123	MNT	TX	C1		Smoking Regime
	123	MNT	TX	C1		Smoke Fraction

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