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

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	8325064	Ames	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	8325064	Ames	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	8325064	Ames	TS	1		STSTDTC	Study Start Date	2015-07-29
4	8325064	Ames	TS	1		STITLE	Study Title	The Bacterial Reverse Mutation Test, Study 8325064-1
5	8325064	Ames	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6	8325064	Ames	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
7	8325064	Ames	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
8	8325064	Ames	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
9	8325064	Ames	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
10	8325064	Ames	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
11	8325064	Ames	TS	1	1	TFCNTRY	Test Facility Country	USA
12	8325064	Ames	TS	1	1	STDIR	Study Director	Dr. R. Smith
13	8325064	Ames	TS	1		GLPFL	GLP Flag	N
14	8325064	Ames	TS	1		ASTD	Assay Standard	OECD Test No. 471
15	8325064	Ames	TS	1		ASTDV	Assay Standard Version	2020-06-29
16	8325064	Ames	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
17	8325064	Ames	TS	1		SSSTYP	Study Sub Type	Bacterial Reverse Mutation Test
18	~~8325064~~	~~Ames~~	TS	1		~~SPECIES~~	~~Species~~	~~Salmonella~~
19	~~8325064~~	~~Ames~~				~~STRAIN~~	~~Strain~~	~~Salmonella typhimurium,~~
20	8325064	Ames	TS	1		CELLLN	Cell Line (this would be Tester Strain for Ames)	TA98 (examples: H292, CHO, TK6.. etc.)

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title	tx.xpt (trial sets)

How do we handle "toxic, no revertant colonies"? (LAK will add 6 records with GTSTAT = NOT DONE, GTREASND = "TOO MUCH CYTOTOXICITY,"
Condition of background bacterial lawn? Slight thinning, Very thin? - refer to SEND team's marked-up table.
- new Test code of Cytotoxicity with GTORRES = S, V (controlled terms)
- Each plate we would have one result record for Revertent count and another for the lawn evaluation (NORMAL, SLIGHT THINNING, VERY THIN)
When "-" in Mean, Std Dev, Fold Inc - refer to SEND team's marked-up table (GTSTAT = NOT DONE; variety of REASND)What do we do for defined regimes (e.g. ISO Regime, Canadian ..) or all attributes should be listed as expected variables to allow for all including custom regimes (Puff volume, etc.)

Below the SETS shown in the TX table are rows A, F, I, and R (probably don't need R)

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXPARMCD	TXPARM	TXVAL
						SPECIES	Species	Salmonella typhimurium
9	8325064	Ames	TX	SetA		STRAIN	Strain/Substrain	TA98
1	8325064	Ames	TX	SetA (Row 1)	A-TA98-C0	METACT	Metabolic

Activation (should there be two parms? Presence, type)?None

Activation
					METACTFL	Y/N presence of metabolic activation	N
2	8325064	Ames	TX	SetA

TRTDRTRG

TRTDMIN

Treatment Duration

target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)

Minimum	71.5
3	8325064	Ames	TX	SetA

TRTDRTOL

TRTDTRG

Treatment Duration

Tolerance

Target	72
4	8325064	Ames	TX	SetA

			TRTDMAX	Treatment Duration Maximum	72.5
							TRTDU

TRTDURU

Treatment Duration Unit	HOURS
		INCBTMP	Incubation Temperature	37
		INCBTMPU	Incubation Temperature Unit

(this is for both TRTDURT, TRTDURTOL)

	C
					HUMID	Atmospheric Relative Humidity Percent	50
					ATMCO2	Atmospheric CO2 Percent	5
					SPTOBID	Sponsor defined tobacco identifier	CIG01a
					EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
					SAMTYP	Sample Type	Total Particulate Matter in PBS
5	8325064	Ames	TX	SetA	INTRVN	name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

DMSO
6	8325064	Ames	TX	SetA			ITVTYPE	type of intervention article

choices of values: product; negative control; positive control

Vehicle Control
7	8325064	Ames	TX	SetA			ITVCONC	Concentration of intervention article	0

(because no TA is used, this is just DMSO)


8	8325064	Ames	TX	SetA			ITVCONCU	Concentration Unit	ug/plate

9

8325064

Ames

TX

SetA

STRAIN

Strain/Substrain

TA98

10

				SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
...				DUREFID	Smoke Regimen	Medium Intensity Regimen
	8325064	Ames	TX

SetAREGIMESmoking RegimeISO Regime...8325064AmesTX

SetF (row 6)			METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
	8325064	Ames	TX	SetF		TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
	8325064	Ames	TX	SetF		TRTDRTOL	Treatment Duration Tolerance
	8325064	Ames	TX	SetF		TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetF		INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	TA1
	8325064	Ames	TX	SetF		ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Product
	8325064	Ames	TX	SetF		ITVCONC	Concentration of intervention article	500
	8325064	Ames	TX	SetF		ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetF		STRAIN	Strain/Substrain	TA98
	8325064	Ames	TX	SetF		REGIME	Smoking Regime	ISO Regime
...
	8325064	Ames	TX	SetI(row 9)		METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
	8325064	Ames	TX	SetI		TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
	8325064	Ames	TX	SetI		TRTDRTOL	Treatment Duration Tolerance
	8325064	Ames	TX	SetI		TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetI		INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	2-Nitrofluorine
	8325064	Ames	TX	SetI		ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Positive Control
	8325064	Ames	TX	SetI		ITVCONC	Concentration of intervention article	5
	8325064	Ames	TX	SetI		ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetI		STRAIN	Strain/Substrain	TA98
	8325064	Ames	TX	SetI		REGIME	Smoking Regime	ISO
...
	8325064	Ames	TX	SetR (Row 18)		METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
	8325064	Ames	TX	SetR		TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
	8325064	Ames	TX	SetR		TRTDRTOL	Treatment Duration Tolerance
	8325064	Ames	TX	SetR		TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetR		INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	4-Nitroquinoline-1-oxide
	8325064	Ames	TX	SetR		ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Positive Control
	8325064	Ames	TX	SetR		ITVCONC	Concentration of intervention article	2
	8325064	Ames	TX	SetR		ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetR		STRAIN	Strain/Substrain	TA98
	8325064	Ames	TX	SetR		REGIME	Smoking Regime	ISO

Revertant Numbers Per Plate	5.0	COLONIES	STANDARD DEVIATION	5.0	5.0			INSTRUMENT COUNTED
	8325064	Ames	GT	SETF		5_1	1	RPP	Revertant Numbers Per Plate	8	8	8	MANUALLY COUNTED
	8325064	Ames	GT	SETF		5_1	1
	8325064	Ames	GT	SETF		5_2	2	RPP	Revertant Numbers Per Plate	10	10	10	MANUALLY COUNTED

	8325064	Ames	GT	SETF		5_3	3	RPP	Revertant Numbers Per Plate	12	12	12	MANUALLY COUNTED
	8325064	Ames	GT	SETF		ALL	6	RPPMEAN	Mean of Revertant Numbers Per Plate	10.0	10.0	10.0
	8325064	Ames	GT	SETF		ALL	7	RPPSTDDV	Standard Deviation of Revertant Numbers Per Plate	2.0	2.0	2.0
	8325064	Ames	GT	SETF		ALL	8	RPPFLDINC	Fold Increase of Revertant Numbers Per Plate	0.3	0.3	0.3
	8325064	Ames	GT	SETI		5_1	1	RPP	Revertant Numbers Per Plate	1104	1104	1104
	8325064	Ames	GT	SETI		5_2	2	RPP	Revertant Numbers Per Plate	1037	1037	1037
	8325064	Ames	GT	SETI		5_3	3	RPP	Revertant Numbers Per Plate	971	971	971
	8325064	Ames	GT	SETI		ALL	6	RPPMEAN	Mean of Revertant Numbers Per Plate	1037.3	1037.3	1037.3
	8325064	Ames	GT	SETI		ALL	7	RPPSTDDV	Standard Deviation of Revertant Numbers Per Plate	66.5	66.5	66.5
	8325064	Ames	GT	SETI		ALL	8	RPPFLDINC	Fold Increase of Revertant Numbers Per Plate	31.4	31.4	31.4

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Old Version 15

New Version 16

Key

SET (what sponsor calls it)