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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 will need to decide appropriate Treatment duration values; If not, what are best example values to show?

AAA

Row	STUDYID	ASSAYID	DOMAIN	SETCD	TXPARMCD	TXPARM	TXVAL
1	123	MNT	TX	A1	METACT	Metabolic Activation	+S9
2	123	MNT	TX	A1	TRTDUR	Treatment Duration	Short Term
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	A2A	METACT	Metabolic Activation	+S9
	123	MNT	TX	AA2	TRTDUR	Treatment Duration	Short Term
	123	MNT	TX	AA2	PRDCONC	Concentration of product	1250
	123	MNT	TX	A2A	PRDCONCU	Concentration Unit	ug/ml
	123	MNT	TX	A2	Product	Product Name
	123	MNT	TX	A2			Smoking Regime
	123	MNT	TX	A2		Smoke Fraction


8	123	MNT	TX	B	METACT	Metabolic Activation	-S9
9	123	MNT	TX	B	TRTDUR	Treatment Duration	Short Term
10	123	MNT	TX	B	TRTDUR	Treatment Duration	Long Term (or 2 parm codes, # and unit)
11	123	MNT	TX	B	PRDCONC	Concentration of product	0
12	123	MNT	TX	B	PRDCONCU	Concentration Unit	ug/ml
13	123	MNT	TX	B	Product	Product Name
14	123	MNT	TX	B		Smoking Regime
15	123	MNT	TX	B		Smoke Fraction

8	123	MNT	TX	C	METACT	Metabolic Activation	-S9
9	123	MNT	TX	C	TRTDUR	Treatment Duration	Long Term
10	123	MNT	TX	C	TRTDUR	Treatment Duration	Long Term (or 2 parm codes, # and unit)
11	123	MNT	TX	C	PRDCONC	Concentration of product	0
12	123	MNT	TX	C	PRDCONCU	Concentration Unit	ug/ml
13	123	MNT	TX	C	Product	Product Name
14	123	MNT	TX	C		Smoking Regime
15	123	MNT	TX	C		Smoke Fraction

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title	gt.xpt (similar to LB)

BLEO & CPA - positive controls?

Row	STUDYID	ASSAYID	DOMAIN	TXCD	GTSEQ	GTTESTCD	GTTEST	GTCELLEV (cells evaluated)	GTORRES	GTORRESU	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC	GTNOMDY	GTELTM	GTTPTREF
1	123	MNT	GT

A

A2	1	RICC		134	15.7	%	15.7	15.7	%	2022-05-25
2	123	MNT	GT

A

A2	2	RCC		134	13.0	%	13.0	13.0	%	2022-05-25
3	123	MNT	GT

A

A2	3	RPD		134	7.9	%	7.9	7.9	%	2022-05-25
4	123	MNT	GT

A

A2	4	MNCELLS	Micronucleated Cells	3266	20	Cells	20	20	Cells	2022-05-25
5	123	MNT	GT

A

A2	5	MNCELLS	Micronucleated Cells	2190	17	Cells	17	17	Cells	2022-05-25
6	123	MNT	GT

A

A2

6

MNCELLS

Micronucleated Cells

7258

2758	13	Cells	13	13	Cells	2022-05-25
7	123	MNT	GT

A

A2	7	MNCELLS	Micronucleated Cells	2714	21	Cells	21	21	Cells	2022-05-25
8	123	MNT	GT	A2	8

7

AVGREL

Average Relative MN Frequency

0.66

%

0.66

%

2022-05-25

8123NRUGT


9	123	MNT	GT	A1	1	RICC		154	0	%	0	0	%	2022-05-25
10	123	MNT	GT	A1	2	RCC		154	0	%	0	0	%	2022-05-25
11	123	MNT	GT	A1	3	RPD		154	0	%	0	0	%	2022-05-25
12	123	MNT	GT	A1	4	MNCELLS	Micronucleated Cells	3266	15	Cells	15	15	Cells	2022-05-25
13	123	MNT	GT	A1	5	MNCELLS	Micronucleated Cells	2190	13	Cells	13	13	Cells	2022-05-25
14	123	MNT	GT	A1	6	MNCELLS	Micronucleated Cells	2758	17	Cells	17	17	Cells	2022-05-25
15	123	MNT	GT	A1	7	MNCELLS	Micronucleated Cells	2714	12	Cells	12	12	Cells	2022-05-25
16	123	MNT	GT	A1	8	AVGREL	Average Relative MN Frequency		0.57	%	0.57	0.57	%	2022-05-25

9GT

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