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This is an example showing trial design and results data of Study #123 for the determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay

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red font - indicates potential for CT code lists purple font - questions to resolve yet

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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
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)red font - indicates potential for CT code lists

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	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
1	123	MNT	GT	A2	1	RICC		134	15.7	%	15.7	15.7	%	2022-05-25
2	123	MNT	GT	A2	2	RCC		134	13.0	%	13.0	13.0	%	2022-05-25
3	123	MNT	GT	A2	3	RPD		134	7.9	%	7.9	7.9	%	2022-05-25
4	123	MNT	GT	A2	4	MNCELLS	Micronucleated Cells	3266	20	Cells	20	20	Cells	2022-05-25
5	123	MNT	GT	A2	5	MNCELLS	Micronucleated Cells	2190	17	Cells	17	17	Cells	2022-05-25
6	123	MNT	GT	A2	6	MNCELLS	Micronucleated Cells	2758	13	Cells	13	13	Cells	2022-05-25
7	123	MNT	GT	A2	7	MNCELLS	Micronucleated Cells	2714	21	Cells	21	21	Cells	2022-05-25
8	123	MNT	GT	A2	8	AVGREL	Average Relative MN Frequency		0.66	%	0.66	0.66	%	2022-05-25
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

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title	concept maps?

Product, Smoking Regime (e.g. Traditional combustible, ENDS), Smoke Fraction, etc.

https://www.itis.gov/servlet/SingleRpt/SingleRpt?search_topic=TSN&search_value=969610#null

One study (Original sample of TK6 cells); (6 rows in GT)

Multiple products
Multiple Assays (Multiple types of assays)

Assay (MN)
3 assay/test conditions;
Treatment duration (2: ST, LT);
Presence of metabolic activation (2: presence, type)

Concentrations of product (6 of these: 0, x, y, z,..., +CNTL);
CytoTox % (3 different percentages from testing 1 portion of the original sample)
4 MN counts conducted (on 4 different portions of original sample?)

EID (5 of these, Count1 - Count4 and Cytotox): with many TX Parm codes??

Cytotox: RICC, RIC, RPD, #cells??

(also see Gentox notes on how to approach modeling, to apply that here?)

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