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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 (what sponsor calls it)	TXSEQ	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

PLATENUM. (e.g., 1 or 2)

1

1-1-APLATENUM1 (or 2)


				1-1-A

WELLNUM

CSC-10

WELLNUM (e.g., 1-A

(

through

12

10-H)	Number representing the location of the well in the 96-well plate	1-A
			1-1-A	CSC-10	INTRVN	name of the intervention article	Cigarette Smoke Condensate
			1-1-A	CSC-10	ITVTYPE (CT e.g, Product, positive control, negative control)	type of intervention article

Product

PRODUCT
	1-1-A	CSC-10	ITVCONC	intervention concentration	10
	1-1-A	CSC-10	ITVCONCU	intervention unit	ug/ml
	1-1

-A

-B	CSC-10		PLATENUM	Plate number	1
				1-1-B

123

CSC-10

MNvitTXA2METACTMetabolic Activation+S9123MNvitTXA2TRTDURTreatment DurationShort Term123MNvitTXA2PRDCONCConcentration of product1250123MNvitTXA2PRDCONCUConcentration Unitug/ml123MNvitTXA2ProductProduct Name123MNvitTXA2Smoking Regime123MNvitTXA2Smoke FractionA6METACTTRTDUR

WELLNUM	Number representing the location of the well in the 96-well plate	2-A
			1-1-B	CSC-10	INTRVN	name of the intervention article	Cigarette Smoke Condensate
			1-1-B	CSC-10	ITVTYPE	type of intervention article	PRODUCT
			1-1-B	CSC-10	ITVCONC	intervention concentration	10
			1-1-B	CSC-10	ITVCONCU	intervention unit	ug/ml
			...
			1-10-H	SLS-10	PLATENUM	Plate number	1
			1-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
			1-10-H	SLS-10

INTRVN

name of the intervention article

Cyclophosphamid A

	sodium laurel sulfate
				1-10-H	SLS-10		ITVTYPE	type of intervention article

Positive controlITVCONCConcentration of i a 5

POSITIVE CONTROL
	1-10-H	SLS-10	ITVCONC	intervention concentration	200
	1-10-H	SLS-10	ITVCONCU	intervention unit

A6ITVCONCUConcentration Unit

ug/ml

A6TCNTL123MNvitTX

B1

METACTMetabolic Activation-S9123MNvitTX

B1

TRTDRTRGTreatment Duration target4TRTDRTOLTreatment Duration Tolerance.25??123MNvitTXB1TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)H

...
2-10-H	SLS-10	PLATENUM	Plate number	2
2-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	2-A
2-10-H	SLS-10	INTRVN	name of the intervention article	sodium laurel sulfate
2-10-H	SLS-10	ITVTYPE	type of intervention article	POSITIVE CONTROL
2-10-H	SLS-10	ITVCONC	intervention concentration	200
2-10-H	SLS-10	ITVCONCU	intervention unit	ug/ml

123MNvitTX

B1

PRDCONCConcentration of product0123MNvitTX

B1

PRDCONCUConcentration Unitug/ml123MNvitTXB1ProductProduct Name123MNvitTXB1Smoking Regime123MNvitTXB1Smoke Fraction123MNvitTX

C1

METACTMetabolic Activation-S9123MNvitTX

C1

TRTDURTreatment Duration24??123MNvitTXC1TRTDURUTreatment Duration UnitH123MNvitTX

C1

PRDCONCConcentration of product0123MNvitTX

C1

PRDCONCUConcentration Unitug/ml123MNvitTX

C1

ProductProduct Name123MNvitTXC1Smoking Regime123MNvitTX

C1

Smoke Fraction

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Versions Compared

Old Version 2

New Version 3

Key

SET (what sponsor calls it)

(plate-col-row in the 96-well plate)

(through SLS-200)

PLATENUM. (e.g., 1 or 2)

WELLNUM (e.g., 1-A

through

10-H)

(CT e.g, Product, positive control, negative control)