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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
Replaced the ASSAYID values of MNT with MNvit (term used in OECD #487) - is this better? This is not a controlled term so we can use anything but what we use in our IG examples are often used in industry implementations so we should use realistic and best practice values as much as possible.
BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
Where is TK6 cell type? is this test system (see below)

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
28	123	ALL	TS	1		GLPFL	GLP Flag	Y
29	123	MNvit	TS	1		ASTD	Assay Standard	OECD Test No. 487
30	123	MNvit	TS	1		ASTDV	Assay Standard Version	2016-07-29
31	123	MNvit	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
32	123	MNvit	TS	1		SSSTYP	Study Sub Type	In Vitro Micronucleus
33	123	MNvit	TS	1		SPECIES	Species	Homo Sapiens
34	123	MNvit	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	GENOTOXICITY IN VITRO
38	123	NRU	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake
39	123	NRU	TS	1		SPECIES	Species	Salmonella enterica
	123	NRU	TS	1		STRAIN	Strain/Substrain	Salmonella enterica enterica
40	123	NRU	TS	1		??	Test System??	Normal Human Keratinocyte
	123	NRU	TS	1		REGIME	Smoking Regime	Traditional combustible
	123	NRU	TS	1
	123	NRU	TS	1		RUNPRT	run-port number?? (always same for whole assay?)	1-1
	123	NRU	TS	1		SMPLID	Sample ID	030001
	123	NRU	TS	1		SMKFRC	Smoke Fraction	A
	123	NRU	TS	1		REPNUM	Replicate Number	1
	123	NRU	TS	1

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title	tx.xpt (trial sets)

During CT definition/reviews will decide appropriate TXPARM and TXVAL; For now, we just include good example values based on our experience
TXPARMCD/TXPARM = TSPARMCD/TSPARM

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	1-1-A (plate-col-row in the 96-well plate)	CSC-10 (through SLS-200)	RNPRT	Run-port number	1-1
				1-1-A		PLATENUM		1 (or 2)
				1-1-A		WELLNUM		1-A (through 12-H)
				1-1-A		INTRVN	name of the intervention article	Cigarette Smoke Condensate
				1-1-A		ITVTYPE	type of intervention article	Product
				1-1-A		ITVCONC	intervention concentration	10
				1-1-A		ITVCONCU	intervention unit	ug/ml
				1-1-A
				1-1-B


	123	MNvit	TX	A2		METACT	Metabolic Activation	+S9
	123	MNvit	TX	A2		TRTDUR	Treatment Duration	Short Term
	123	MNvit	TX	A2		PRDCONC	Concentration of product	1250
	123	MNvit	TX	A2		PRDCONCU	Concentration Unit	ug/ml
	123	MNvit	TX	A2		Product	Product Name
	123	MNvit	TX	A2			Smoking Regime
	123	MNvit	TX	A2			Smoke Fraction
				A6		METACT
						TRTDUR
						INTRVN	name of the intervention article	Cyclophosphamid A
						ITVTYPE	type of intervention article	Positive control
						ITVCONC	Concentration of i a	5
				A6		ITVCONCU	Concentration Unit	ug/ml
				A6		TCNTL
	123	MNvit	TX	B1		METACT	Metabolic Activation	-S9
	123	MNvit	TX	B1		TRTDRTRG	Treatment Duration target	4
						TRTDRTOL	Treatment Duration Tolerance	.25
??	123	MNvit	TX	B1		TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	MNvit	TX	B1		PRDCONC	Concentration of product	0
	123	MNvit	TX	B1		PRDCONCU	Concentration Unit	ug/ml
	123	MNvit	TX	B1		Product	Product Name
	123	MNvit	TX	B1			Smoking Regime
	123	MNvit	TX	B1			Smoke Fraction
	123	MNvit	TX	C1		METACT	Metabolic Activation	-S9
	123	MNvit	TX	C1		TRTDUR	Treatment Duration	24
??	123	MNvit	TX	C1		TRTDURU	Treatment Duration Unit	H
	123	MNvit	TX	C1		PRDCONC	Concentration of product	0
	123	MNvit	TX	C1		PRDCONCU	Concentration Unit	ug/ml
	123	MNvit	TX	C1		Product	Product Name
	123	MNvit	TX	C1			Smoking Regime
	123	MNvit	TX	C1			Smoke Fraction

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title	gt.xpt (similar to LB)

Row	STUDYID	ASSAYID	DOMAIN	TXCD	GTSEQ	GTTESTCD	GTTEST	GTCELLEV (cells evaluated)	GTORRES	GTORRESU	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC
				1-1-A	1	RELABS	Relative Absorbance Reading		100	ug/ml	100	100	ug/ml
					2	...
					8	AVGREL









10	123	MNvit	GT	A1	2	RCC		154	0	%	0	0	%	2022-05-25
11	123	MNvit	GT	A1	3	RPD		154	0	%	0	0	%	2022-05-25
12	123	MNvit	GT	A1	4	MNCELLS	Micronucleated Cells	3266	15	Cells	15	15	Cells	2022-05-25
13	123	MNvit	GT	A1	5	MNCELLS	Micronucleated Cells	2190	13	Cells	13	13	Cells	2022-05-25
14	123	MNvit	GT	A1	6	MNCELLS	Micronucleated Cells	2758	17	Cells	17	17	Cells	2022-05-25
15	123	MNvit	GT	A1	7	MNCELLS	Micronucleated Cells	2714	12	Cells	12	12	Cells	2022-05-25
16	123	MNvit	GT	A1	8	AVGREL	Average Relative MN Frequency		0.57	%	0.57	0.57	%	2022-05-25

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