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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
Assumption: SPTOBID (product identifier) should be added at the trial set level (tx.xpt)
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	MNvit	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123	MNvit	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123	MNvit	TS	1		STSTDTC	Study Start Date	2022-05-25
4	123	MNvit	TS	1		STITLE	Study Title	Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay
5	123	MNvit	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6	123	MNvit	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
7	123	MNvit	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
8	123	MNvit	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
9	123	MNvit	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
10	123	MNvit	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
11	123	MNvit	TS	1	1	TFCNTRY	Test Facility Country	USA
12	123	MNvit	TS	1	1	STDIR	Study Director	Dr. R. Smith
13	123	MNvit	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
20	123	MNvit	TS	1		SPTOBID	Sponsor defined tobacco product identifier	CIG01a
21	123	MNvit	TS	1	1?	TCVAR1	Product testing conditions	PTTSTCND
22	123	MNvit	TS	1	1?	TCVRVAL1		E-Liquid Standard (Long Term) Condition

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title	to.xpt (Tobacco Identifiers)

Rows 1-4:	Show the records for the product identifiers for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT IDENTIFIERS.
Rows 5-10:	Show the records for the product descriptors for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT DESCRIPTOR.

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCD	TOTEST	TOCAT	TOORRES	TOORRESU	TOSTRESC	TOSTRESN	TOSTRESU
1	TOB07	TO	CIG01a	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	Cigarette		Cigarette
2	TOB07	TO	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Filtered, Combusted		Filtered, Combusted
3	TOB07	TO	CIG01a	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	Joes Cigs USA		Joes Cigs USA
4	TOB07	TO	CIG01a	4	TRADENAM	Trade Name	PRODUCT IDENTIFIER	Treetop Menthol King Size		Treetop Menthol King Size
5	TOB07	TO	CIG01a	5	PACKTYP	Package Type	PRODUCT DESCRIPTOR	HARD PACK		HARD PACK
6	TOB07	TO	CIG01a	6	PRDQUAN	Product Quantity	PRODUCT DESCRIPTOR	20	CIGARETTE	20	20	CIGARETTE
7	TOB07	TO	CIG01a	7	LENGTH	Length	PRODUCT DESCRIPTOR	86.0	mm	86.0	86.0	mm
8	TOB07	TO	CIG01a	8	CIRCUMF	Circumference	PRODUCT DESCRIPTOR	26.0	mm	26.0	26.0	mm
9	TOB07	TO	CIG01a	9	VENTLTN	Ventilation	PRODUCT DESCRIPTOR	10.0	%	10.0	10.0	%
10	TOB07	TO	CIG01a	10	CHARFLAV	Characterizing Flavor	PRODUCT DESCRIPTOR	MENTHOL		MENTHOL

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title	TC (Test Conditions) aka Smoking Regimen

The Test Conditions (TC) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset.

The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TCVAR1="PTTSTCND" and TCVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TCPARMCD/TCPARM. TCVAL and TCVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above.
(We've added TCVALU which was not originally part of the TC draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TCVALU)

Dataset wrap

Name	tc

Dataset2

Row	STUDYID	DOMAIN	RDOMAIN	TCVAR1	TCVRVAL1	TCSEQ	TCGRPID	TCPARMCD	TCPARM	TCVAL	TCVALU
1	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	1		PUFFPROF	Puff Profile	SQUARE
2	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	2		PUFFDUR	Puff Duration	1.25	sec
3	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	3		PUFFINT	Puff Interval	3	PUFF/min
4	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	4		PUFFBLCK	Puff Block	25	%
5	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	5		NUMPUFF	Total Number of Puffs	200	PUFF
6	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	6		PUFFVOL	Puff Volume	10	mL
7	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	7		PUFFRNG	Puff Range	100-200
8	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	8	1	PUFFPAUS	Puff Pause	60	s
9	TOB07	TC	PT	PTTSTCND	E-Liquid Standard (Long Term) Condition	9	1	PUFFPINT	Puff Pause Interval	10	PUFF

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