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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

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	NRU	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123	NRU	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123	NRU	TS	1		STSTDTC	Study Start Date	2022-05-25
4	123	NRU	TS	1		STITLE	Study Title	Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay
5	123	NRU	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6	123	NRU	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
7	123	NRU	TS	1		SSPONSOR	Sponsor Applicant's Organization Organization	Example Applicant Inc.
8	123	NRU	TS	1		SPREFID	Sponsor's Applicant'sStudy Reference ID		NOT APPLICABLE
9	123	NRU	TS	1	1	TSTFNAM	Test Facility Name	Example ~~Tox~~ Testing Lab Name
10	123	NRU	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
11	123	NRU	TS	1	1	TFCNTRY	Test Facility Country	USA
12	123	NRU	TS	1	1	STDIR	Study Director	Dr. R. Smith
13	123	NRU	TS	1		GLPFL	GLP Flag	Y
14	123	NRU	TS	1		ASTD	Assay Standard	NIH Publication No. 07-4519
15	123	NRU	TS	1		ASTDV	Assay Standard Version	2006-11
16	123	NRU	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
17	123	NRU	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake
18	123	NRU	TS	1		SPECIES	Species	Chinese Hamster
19	123	NRU	TS	1		TESTSYS	Test System	CHO

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title	tx.xpt (trial sets)

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~~ applicant designations as specified in the trial design.
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
Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
Smoke fraction? is this indicator of processing of material from smoke machine..we used Smoke Exposure System - ok?
Incubate cells (37 ºC ±1 ºC, 90% ±10% humidity, and 5% ±1% CO2/air) - these are ranges, do we model for ranges?
- https://ntp.niehs.nih.gov/iccvam/docs/protocols/ivcyto-nhk.pdf

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	CSC-50	CSC-50	1	TRTDMIN	Treatment Duration Minimum	47.5
2	123	NRU	TX	CSC-50	CSC-50	2	TRTDTRG	Treatment Duration Target	48
3	123	NRU	TX	CSC-50	CSC-50	3	TRTDMAX	Treatment Duration Maximum	48.5
4	123	NRU	TX	CSC-50	CSC-50	4	TRTDU	Treatment Duration Unit	HOURS
5	123	NRU	TX	CSC-50	CSC-50	5	INCBTMP	Incubation Temperature	37
6	123	NRU	TX	CSC-50	CSC-50	6	INCBTMPU	Incubation Temperature Unit	C
7	123	NRU	TX	CSC-50	CSC-50	7	WAVELGTH	Spectrophotometer WAVELENGTH IN NANOMETERS	540
8	123	NRU	TX	CSC-50	CSC-50	8	HUMID	Atmospheric Relative Humidity Percent	90
9	123	NRU	TX	CSC-50	CSC-50	9	ATMCO2	Atmospheric CO2 Percent	5
10	123	NRU	TX	CSC-50	CSC-50	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
11	123	NRU	TX	CSC-50	CSC-50	11	EXPTYP	Exposure Type	Air Liquid Interface
12	123	NRU	TX	CSC-50	CSC-50	12	SAMTYP	Sample Type	Whole Smoke Conditioned Media
13	123	NRU	TX	CSC-50	CSC-50	13	INTRVN	Name of the Intervention Article	Tobacco ProdA
14	123	NRU	TX	CSC-50	CSC-50	14	ITVTYPE (CT e.g, Product, positive control, negative control, vehicle control, solvent control)	type of intervention article	PRODUCT
15	123	NRU	TX	CSC-50	CSC-50	15	ITVCONC	intervention concentration	50
16	123	NRU	TX	CSC-50	CSC-50	16	ITVCONCU	intervention unit	ug/ml
17	123	NRU	TX	CSC-50	CSC-50	17	STRAIN	Strain/Substrain	CHO
18	123	NRU	TX	CSC-50	CSC-50	18	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
19	123	NRU	TX	CSC-50	CSC-50	19	DUREFID	Smoking Regime	Medium Intensity Regimen
20	123	NRU	TX	CSC-50	CSC-50	20	SPTOBID	Sponsor defined tobacco identifier	CIG01a
21	123	NRU	TX	SLS-110	SLS-110	1	TRTDMIN	Treatment Duration Minimum	47.5
22	123	NRU	TX	SLS-110	SLS-110	2	TRTDTRG	Treatment Duration Target	48
23	123	NRU	TX	SLS-110	SLS-110	3	TRTDMAX	Treatment Duration Maximum	48.5
24	123	NRU	TX	SLS-110	SLS-110	4	TRTDU	Treatment Duration Unit	HOURS
25	123	NRU	TX	SLS-110	SLS-110	5	INCBTMP	Incubation Temperature	37
26	123	NRU	TX	SLS-110	SLS-110	6	INCBTMPU	Incubation Temperature Unit	C
27	123	NRU	TX	SLS-110	SLS-110	7	WAVELGTH	Spectrophotometer WAVELENGTH IN NANOMETERS	540
28	123	NRU	TX	SLS-110	SLS-110	8	HUMID	Atmospheric Relative Humidity Percent	90
29	123	NRU	TX	SLS-110	SLS-110	9	ATMCO2	Atmospheric CO2 Percent	5
30	123	NRU	TX	SLS-110	SLS-110	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
31	123	NRU	TX	SLS-110	SLS-110	11	EXPTYP	Exposure Type	Air Liquid Interface
32	123	NRU	TX	SLS-110	SLS-110	12	SAMTYP	Sample Type	Liquid
33	123	NRU	TX	SLS-110	SLS-110	13	INTRVN	Name of the Intervention Article	Sodium Laurel Sulfate
34	123	NRU	TX	SLS-110	SLS-110	14	ITVTYPE (CT e.g, Product, positive control, negative control, vehicle control, solvent control)	type of intervention article	POSITIVE CONTROL
35	123	NRU	TX	SLS-110	SLS-110	15	ITVCONC	intervention concentration	200
36	123	NRU	TX	SLS-110	SLS-110	16	ITVCONCU	intervention unit	ug/ml
37	123	NRU	TX	SLS-110	SLS-110	17	STRAIN	Strain/Substrain	CHO
38	123	NRU	TX	SLS-110	SLS-110	18	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
39	123	NRU	TX	SLS-110	SLS-110	19	DUREFID	Smoking Regime	Medium Intensity Regimen
40	123	NRU	TX	SLS-110	SLS-110	20	SPTOBID	Sponsor defined tobacco identifier	CIG01a

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Old Version 51

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Key

SET (what sponsor calls it)

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

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