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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
This example currently shows SPDEVID and DUREFID in BOTH the TS domain and the TX domain, but we should discuss if this should only ever be in TX (with the same value for all sets if there is only one device used)
Assumption: SPTOBID SPDEVID (product sponsor defined device identifier) should be added at the trial set level (tx.xpt) - we can discuss if this should be in TS when there is only one device for a study
- 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)

SPTOBID tobacco product CIG01a1?

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		SPDEVID	Sponsor defined	device identifier	PUFFMASTER3K
21	123	MNvit	TS	1		DUREFID	TCVAR1	Product testing conditions	PTTSTCND	22	123	MNvit	TS	1	1?	TCVRVAL1	E-Liquid Standard (Long Term) Condition	Smoke Regimen	Medium Intensity Regimen

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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.
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:

A2:

Row	STUDYID	ASSAYID	DOMAIN	SETCD	TXSEQ	TXPARMCD	TXPARM	TXVAL
	123	MNvit	TX	A1 (table 1, row 1, ST exposure with S9)		METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
						METACTFL	Y/N presence of metabolic activation
	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		INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	Tobacco ProdA
	123	MNvit	TX	A1		ITVTYPE	type of intervention article 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	ug/ml
	123	MNvit	TS	A1	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
	123	MNvit	TS	A1	DUREFID	Smoke Regimen	Medium Intensity Regimen
	123	MNvit	TX	A2 (table 1, row 2)		METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
	123	MNvit	TX	A2		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	A2		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	Tobacco ProdA
	123	MNvit	TX	A2		ITVTYPE	type of intervention article	Product
	123	MNvit	TX	A2		ITVCONC	Concentration of i a	1250
	123	MNvit	TX	A2		ITVCONCU	Concentration Unit	ug/ml
	123	MNvit	TS	A2	SPDEVID	Sponsor defined device identifier	PUFFMASTER2023
	123	MNvit	TS	A2	DUREFID	Smoke Regimen	High Intensity Regimen
...

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title	to.xpt (Tobacco Identifiers)

Smoking regimen is represented in --REFID (we made up a value of "Medium Intensity Regimen"; we can update with something realistic)
The smoking regimen is carried out by the smoking machine/device shown in SPDEVID, Sponsor defined device identifier, "PUFFMASTER3K"
Do we need both SPDEVID AND DUREFID?

du.

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

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

Row	STUDYID	DOMAIN

SPTOBID

SPDEVID	DUSEQ

TOSEQ

DUREFID

TOTESTCD

DUGRPID

TOTEST

DUTESTCD

TOCAT

DUTEST

TOORRES

DUORRES

TOORRESU

DUORRESU

TOSTRESC

DUSTRESC

TOSTRESN

DUSTRESN

TOSTRESU

DUSTRESU
1

TOB07

123

TO

DU

CIG01a

PUFFMASTER3K

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERCigaretteCigarette

2
Medium Intensity Regimen		PUFFPROF	Puff Profile	SQUARE		SQUARE

TOB07

123

TO

DU

CIG01a

PUFFMASTER3K

2

TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERFiltered, CombustedFiltered, Combusted3TOB07TOCIG01a3MANUFManufacturerPRODUCT IDENTIFIERJoes Cigs USAJoes Cigs USA4TOB07TOCIG01a4TRADENAMTrade NamePRODUCT IDENTIFIERTreetop Menthol King SizeTreetop Menthol King Size5TOB07TOCIG01a5PACKTYPPackage TypePRODUCT DESCRIPTORHARD PACKHARD PACK6TOB07TOCIG01a6PRDQUANProduct QuantityPRODUCT DESCRIPTOR20CIGARETTE2020CIGARETTE7TOB07TOCIG01a7LENGTHLengthPRODUCT DESCRIPTOR86.0mm86.086.0mm8TOB07TOCIG01a8CIRCUMFCircumferencePRODUCT DESCRIPTOR26.0mm26.026.0mm9TOB07TOCIG01a9VENTLTNVentilationPRODUCT DESCRIPTOR10.0%10.010.0%10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorPRODUCT DESCRIPTORMENTHOLMENTHOL

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Versions Compared

Old Version 54

New Version 55

Key

SET (what sponsor calls it)