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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
Sponsor should be "applicant", how do we represent this?
TK6, human keratinocyte, is this "test system"?
Can we draft a starting list of Study Types and Sub Types to submit to CT now?
Is there a dictionary of species and/or strain that we would use? (see example)

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 of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake
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	Example Applicant Inc.
8	123	NRU	TS	1		SPREFID	~~Sponsor's~~ Applicant's Study 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	Salmonella enterica
19	123	NRU	TS	1		??	Test System??	TK6 Normal Human Keratinocyte

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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.)

(how is this different from REPNUM)

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	1-1-A (plate-col-row in the 96-well plate)	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
7	123	NRU	TX	1-1-A	CSC-10	STRAIN	Strain/Substrain	Salmonella enterica enterica
8	123	NRU	TX	1-1-A	CSC-10	REGIME	Smoking Regime	Traditional combustible
9	123	NRU	TX	1-1-A	CSC-10	RUN	Assay run number		1
10	123	NRU	TX	1-1-A	CSC-10	PORT	Port ID	1
11	123	NRU	TX	1-1-A	CSC-10	SMPLID	Sample ID	030001
12	123	NRU	TX	1-1-A	CSC-10	SMKFRC	Smoke Fraction	A
13	123	NRU	TX	1-1-A	CSC-10	REPNUM	Replicate Number	1
1	123	NRU	TX	1-1-B	CSC-10	PLATENUM. (e.g., 1 or 2)	1	1
2	123	NRU	TX	1-1-B	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-B	CSC-10	INTRVN	name of the intervention article	Cigarette Smoke Condensate
4	123	NRU	TX	1-1-B	CSC-10	ITVTYPE (CT e.g, Product, positive control, negative control)	type of intervention article	PRODUCT
5	123	NRU	TX	1-1-B	CSC-10	ITVCONC	intervention concentration	10
6	123	NRU	TX	1-1-B	CSC-10	ITVCONCU	intervention unit	ug/ml
7	123	NRU	TX	1-1-B	CSC-10	STRAIN	Strain/Substrain	Salmonella enterica enterica
8	123	NRU	TX	1-1-B	CSC-10	REGIME	Smoking Regime	Traditional combustible
9	123	NRU	TX	1-1-B	CSC-10	RUN	Assay run number	1
10	123	NRU	TX	1-1-B	CSC-10	PORT	Port ID	1
11	123	NRU	TX	1-1-B	CSC-10	SMPLID	Sample ID	030001
12	123	NRU	TX	1-1-B	CSC-10	SMKFRC	Smoke Fraction	A
13	123	NRU	TX	1-1-B	CSC-10	REPNUM	Replicate Number	1


14	123	NRU	TX	1-1-B	CSC-10	ITVCONC	intervention concentration	10
15	123	NRU	TX	1-1-B	CSC-10	ITVCONCU	intervention unit	ug/ml
...				...
	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	sodium laurel sulfate
	123	NRU	TX	1-10-H	SLS-10	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
...				...
	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	intervention unit	ug/ml

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Versions Compared

Old Version 18

New Version 19

Key

SET (what sponsor calls it)

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

(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)

PLATENUM. (e.g., 1 or 2)

WELLNUM (e.g., 1-A through 10-H)

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