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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)

3233373840TS

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	ALL	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123	ALL	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
311	123	ALL	TS	1		STSTDTC	Study Start Date	20072022-1205-3025
134	123	ALL	TS	1		STITLE	Study Title	Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods	Determination of the in vitro genotoxicity potential of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake
514	123	ALL	TS	1		SNDIGVER	SEND Implementation Guide Version	Tobacco TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
156	123	ALL	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-0309-2630
177	123	ALL	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
188	123	ALL	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
199	123	ALL	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
2010	123	ALL	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
2111	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
	123	MNvit	TS	1		SSSTYP	Study Sub Type	In Vitro Micronucleus
	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
	123	NRU	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
	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
	123	NRU	TS	1		??	Test System??	Normal Human Keratinocyte
	123	NRU	TS	1		REGIME	Smoking Regime	Traditional combustible	123	NRU		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)	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	1-1-A (plate-col-row in the 96-well plate)	CSC-10 (through SLS-200)	PLATENUM. (e.g., 1 or 2)	1	1
2	123	NRU	TX	1-1-A	CSC-10	WELLNUM (e.g., 1-A through 10-H)	Number representing the location of the well in the 96-well plate	1-A
3	123	NRU	TX	1-1-A	CSC-10	INTRVN	name of the intervention article	Cigarette Smoke Condensate
4	123	NRU	TX	1-1-A	CSC-10	ITVTYPE (CT e.g, Product, positive control, negative control)	type of intervention article	PRODUCT
5	123	NRU	TX	1-1-A	CSC-10	ITVCONC	intervention concentration	10
6	123	NRU	TX	1-1-A	CSC-10	ITVCONCU	intervention unit	ug/ml
7	123	NRU	TX	1-1-B	CSC-10	PLATENUM	Plate number	1
8	123	NRU	TX	1-1-B	CSC-10	WELLNUM	Number representing the location of the well in the 96-well plate	2-A
9	123	NRU	TX	1-1-B	CSC-10	INTRVN	name of the intervention article	Cigarette Smoke Condensate
10	123	NRU	TX	1-1-B	CSC-10	ITVTYPE	type of intervention article	PRODUCT
11	123	NRU	TX	1-1-B	CSC-10	ITVCONC	intervention concentration	10
12	123	NRU	TX	1-1-B	CSC-10	ITVCONCU	intervention unit	ug/ml
...				...
	123	NRU	TX	1-10-H	SLS-10	PLATENUM	Plate number	1
	123	NRU	TX	1-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	1-10-H	SLS-10	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	1-10-H	SLS-10	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	1-10-H	SLS-10	ITVCONC	intervention concentration	200
	123	NRU	TX	1-10-H	SLS-10	ITVCONCU	intervention unit	ug/ml
...				...
	123	NRU	TX	2-10-H	SLS-10	PLATENUM	Plate number	2
	123	NRU	TX	2-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	2-A
	123	NRU	TX	2-10-H	SLS-10	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	2-10-H	SLS-10	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	2-10-H	SLS-10	ITVCONC	intervention concentration	200
	123	NRU	TX	2-10-H	SLS-10	ITVCONCU	intervention unit	ug/ml

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title	gt.xpt (similar to LB)

Image Added

Row	STUDYID	ASSAYID	DOMAIN	TXCD	GTSEQ	GTTESTCD	GTTEST	GTCELLEV (cells evaluated)	GTORRES	GTORRESU	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC	GTNOMDY	GTELTM	GTTPTREF
1	123	NRU	GT	1-1-A	1	RELABS	Relative Absorbance Reading		100	ug/ml	100	100	ug/ml
2

...

123

8

NRU

AVGREL

10

123

MNvit

GT

A1

2

RCC

154

0

%

0

%

2022-05-25

11

123

MNvit

GT

A1

3

RPD

154

0

%

0

%

2022-05-25

12

123

MNvit

GT

A1

4

MNCELLS

Micronucleated Cells

3266

15

Cells

15

Cells

2022-05-25

13

123

MNvit

GT

A1

5

MNCELLS

Micronucleated Cells

2190

13

Cells

13

Cells

2022-05-25

GT	1-1-B	1	RELABS	Relative Absorbance Reading		107	ug/ml	100	100	ug/ml
3	123	NRU	GT	1-1-C	1	RELABS	Relative Absorbance Reading		98.6	ug/ml	100	100	ug/ml
54	123	NRU	GT	1-1-D	1	RELABS	Relative Absorbance Reading		94.9	ug/ml	100	100	ug/ml
6	123	NRU	GT	1-1-E	1	RELABS	Relative Absorbance Reading		111
7	123	NRU	GT	1-1-F	1	RELABS	Relative Absorbance Reading		96.9
8	123	NRU	GT	1-1-G	1	RELABS	Relative Absorbance Reading		105
9	123	NRU	GT	1-1-H	1	RELABS	Relative Absorbance Reading		95.2
10	123	NRU	GT	1-2-A	1	RELABS	Relative Absorbance Reading		83.0
11	123	NRU	GT	1-2-B	1	RELABS	Relative Absorbance Reading		77.7
...				...
80	123	NRU	GT	1-10-H	1	RELABS	Relative Absorbance Reading		0.791
...				...
160	123	NRU	GT	2-10-H	1	RELABS	Relative Absorbance Reading		0.780

14123MNvitGTA16MNCELLSMicronucleated Cells275817Cells1717Cells2022-05-2515123MNvitGTA17MNCELLSMicronucleated Cells271412Cells1212Cells2022-05-2516123MNvitGTA18AVGRELAverage Relative MN Frequency0.57%0.570.57%2022-05-25

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Versions Compared

Old Version 3

New Version 4

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)