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red font - indicates potential for CT code lists green font - links to other domains purple font - to be discussed

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title	Study 123, Report Table

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

Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
Assumption: A Trial (study) can have more than one assay type
Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study

123

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	ALLMNvit	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123	ALLMNvit	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123	ALLMNvit	TS	1		STSTDTC	Study Start Date	2022-05-25
4	123	ALLMNvit	TS	1		STITLE	Study Title	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
5	123	ALLMNvit	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6	123	ALLMNvit	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
7	123	ALLMNvit	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
8	123	ALLMNvit	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
9	123	ALLMNvit	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
10	123	ALLMNvit	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
11	123	ALLMNvit	TS	1	1	TFCNTRY	Test Facility Country	USA
...12	123	ALLMNvit	TS	1	1	STDIR	Study Director	Dr. R. Smith
13	123	ALLMNvit	TS	1		GLPFL	GLP Flag	Y
14	123	MNvit	TS	1		ASTD	Assay Standard	OECD Test No. 487
15	123	MNvit	TS	1		ASTDV	Assay Standard Version	2016-07-29
16	123	MNvit	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
17	123	MNvit	TS	1		SSSTYP	Study Sub Type	In Vitro Micronucleus
18	123	MNvit	TS	1		SPECIES	Species	Homo Sapiens
19	123	MNvit	TS	1		??	Test System?	TK6 Lymphoblastoid Suspension Cells		NRU	TS	1	ASTD	Assay Standard	NIH Publication No. 07-4519	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	123	NRU	TS	1	SPECIES	Species	Salmonella enterica	123	NRU	TS	1	??	Test System??	Normal Human Keratinocyte

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title	tx.xpt (trial sets)

During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
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)
- needs to be allowed to vary down to the well level / result level

A1: Image Added

A2: Image Added

1NRU-1-A

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

sodium laurel sulfateNRUSLS-10intervention unit

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXSEQ	TXPARMCD	TXPARM	TXVAL
	123	MNvit	TX	A1 (table 1	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	123	NRU	1	STRAIN	Strain/Substrain	Salmonella enterica enterica	123	NRU	1	REGIME	Smoking Regime	Traditional combustible	123	NRU	1	RUN	Assay run number (how is this different from REPNUM)	1	123	NRU	1	PORT	Port ID	1	123	NRU	1	SMPLID	Sample ID	030001	123	NRU	1	SMKFRC	Smoke Fraction	A	123	NRU	1	REPNUM	Replicate Number	1	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	...	...	, row 1, ST exposure with S9)	METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
	123	MNvit	TX	A1			TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)	3
	123	MNvit	TX	A1			TRTDRTOL	Treatment Duration Tolerance
	123	MNvit	TX	A1			TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	MNvit	TX	A1			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	(Tobacco ProdA, Bleomycin or Cyclophosphamid A)	Tobacco ProdA
	123	MNvit	TX	1-10-H	A1			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	...	...	choices of values: product; negative control; positive control	Product
	123	MNvit	TX	A1			ITVCONC	Concentration of intervention article	0
	123	MNvit	TX	A1			ITVCONCU	Concentration Unit	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	10-H	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		ug/ml
	123	MNvit	TXA1	A2 (table 1, row 2)			METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
	123	MNvit	TX	A1A2			TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)	3
	123	MNvit	TX	123A2	MNvit	TX			TRTDRTOL	Treatment Duration Tolerance
	123	MNvit	TX	A2			TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	MNvit	TX	A2			INTRVN	name of the intervention article	Bleomycin or Cyclophosphamid ATobacco ProdA
	123	MNvit	TX	A2			ITVTYPE	type of intervention article	choices of values: product; negative control; positive controlProduct
	123	MNvit	TX	A1A2			ITVCONC	Concentration of i a	01250
	123	MNvit	TX	A1A2			ITVCONCU	Concentration Unit	ug/ml
...

NRU

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title	gt.xpt (similar to LB)

A1: Image Added

A2: Image AddedImage RemovedImage Removed

Row	STUDYID	ASSAYID	DOMAIN

TXCD

TXSETCD	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

ug/ml

2

123

NRU

GT

1-1-B

1

RELABS

Relative Absorbance Reading

107

ug/ml

100

ug/ml

3

123

NRU

GT

1-1-C

1

RELABS

Relative Absorbance Reading

98.6

ug/ml

100

ug/ml

54

123

NRU

GT

1-1-D

1

RELABS

Relative Absorbance Reading

94.9

ug/ml

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

GT2-10-H1

1

RELABSRelative Absorbance Reading0.780

123

MNvit

GT

A2

A1

1

RICC

Relative Increase in Cell Count

134

154

15.7

0

%

15.7

0

15.7

	%	2022-05-25
2	123	MNvit	GT

A2

A1

2

RCC

Relative Cell Count

134

154

13.

0

%

13.

0

13.

0	%	2022-05-25
3	123	MNvit	GT

A2

A1

3

RPD

Relative Population Doubling

134

154

7.9

0

%

7.9

0

7.9

	%	2022-05-25
4	123	MNvit	GT

A2

A1

4

MNCELLS

Micronucleated Cells

3266

2205

20

15

Cells

20

15

20

15	Cells	2022-05-25
5	123	MNvit	GT

A2

A1

5

MNCELLS

Micronucleated Cells

2190

2474

17

13

Cells

17

13

17

13	Cells	2022-05-25
6	123	MNvit	GT

A2

A1

6

MNCELLS

Micronucleated Cells

2758

13

17

Cells

13

17

13

17	Cells	2022-05-25
7	123	MNvit	GT

A2

A1

7

MNCELLS

Micronucleated Cells

2714

2669

21

12

Cells

21

12

21

12	Cells	2022-05-25
8	123	MNvit	GT

A2

A1

8

AVGREL

Average Relative MN Frequency

0.

66

57

%

0.

66

57

0.

66

57	%	2022-05-25
9	123	MNvit	GT

A1

A2

1

RICC

Relative Increase in Cell Count

154

134

0

15.7

%

0

15.7

0

	%	2022-05-25
10	123	MNvit	GT

A1

A2

2

RCC

Relative Cell Count

154

134	13.0	%	13.0	13.0	%	2022-05-25
11	123	MNvit	GT

A1

A2

3

RPD

Relative Population Doubling

154

134

0

7.9

%

0

7.9

0

	%	2022-05-25
12	123	MNvit	GT

A1

A2

4

MNCELLS

Micronucleated Cells

3266

15

20

Cells

15

20

15

20	Cells	2022-05-25
13	123	MNvit	GT

A1

A2

5

MNCELLS

Micronucleated Cells

2190

13

17

Cells

13

17

13

17	Cells	2022-05-25
14	123	MNvit	GT

A1

A2

6

MNCELLS

Micronucleated Cells

2758

17

13

Cells

17

13

17

13	Cells	2022-05-25
15	123	MNvit	GT

A1

A2

7

MNCELLS

Micronucleated Cells

2714

12

21

Cells

12

21

12

21	Cells	2022-05-25
16	123	MNvit	GT

A1

A2

8

AVGREL

Average Relative MN Frequency

0.

57

66

%

0.

57

66

0.

57

66	%	2022-05-25
...

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Versions Compared

Old Version 40

New Version 41

Key

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

SET (what sponsor calls it)

(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)

Below this line are domains we currently do not see a use for