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title	Study 123, Raw data (for reference only, will be deleted?)

Dataset wrap

Rowcaps

Rows 1-2:	Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study.
Row 8:	Shows that the sponsor's study reference ID is not applicable.
Rows 9-12:	Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The Study Director is associated with the Test Facility.

Dataset2

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 Organization	Example Sponsor Inc.
8	123	NRU	TS	1		SPREFID	Sponsor Study Reference ID		NOT APPLICABLE
9	123	NRU	TS	1	1	TSTFNAM	Test Facility Name	Example Test 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	Hamster
19	123	NRU	TS	1		TESTSYS	Test System	CHO

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title	ts.xpt (trial summary, study level parameters)

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: SPDEVID and DUREFID should only be in TX (with the same value for all sets if there is only one device used)
Assumption: SPDEVID (sponsor defined device identifier) should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- 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

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