Page History

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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

Sponsor Organization

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

Dataset wrap

Rowcaps

Rows 1-20:	Show the test conditions for the set with a short name or SETCD value of CSC-50b. The sponsor chose this value to represent plate number 1, well number 1, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Row 17:	Shows the value for STRAIN/SUBSTRAIN is NO STRAIN because the well is a media only well, having no CHO Hamster cells.
Rows 21-40:	Show the test conditions for the set with a short name or SETCD value of CSC-50. The sponsor chose this value to represent plate number 1, well number 2, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Rows 41-60:	Show the test conditions for the set with a short name or SETCD value of CSC-50. The sponsor chose this value to represent both wells numbered 7 in plate number 1 and 2, with a concentration of 110µg/mLof Sodium Laurel Sulfate as shown in the report table for study 123

Dataset2

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	CSC-50b	CSC-50-blank	1	TRTDMIN	Treatment Duration Minimum	47.5
2	123	NRU	TX	CSC-50b	CSC-50-blank	2	TRTDTRG	Treatment Duration Target	48
3	123	NRU	TX	CSC-50b	CSC-50-blank	3	TRTDMAX	Treatment Duration Maximum	48.5
4	123	NRU	TX	CSC-50b	CSC-50-blank	4	TRTDU	Treatment Duration Unit	HOURS
5	123	NRU	TX	CSC-50b	CSC-50-blank	5	INCBTMP	Incubation Temperature	37
6	123	NRU	TX	CSC-50b	CSC-50-blank	6	INCBTMPU	Incubation Temperature Unit	C
7	123	NRU	TX	CSC-50b	CSC-50-blank	7	WAVELGTH	Spectrophotometer WAVELENGTH IN NANOMETERS	540
8	123	NRU	TX	CSC-50b	CSC-50-blank	8	HUMID	Atmospheric Relative Humidity Percent	90
9	123	NRU	TX	CSC-50b	CSC-50-blank	9	ATMCO2	Atmospheric CO2 Percent	5
10	123	NRU	TX	CSC-50b	CSC-50-blank	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
11	123	NRU	TX	CSC-50b	CSC-50-blank	11	EXPTYP	Exposure Type	Air Liquid Interface
12	123	NRU	TX	CSC-50b	CSC-50-blank	12	SAMTYP	Sample Type	Whole Smoke Conditioned Media
13	123	NRU	TX	CSC-50b	CSC-50-blank	13	INTRVN	Name of the Intervention Article	Tobacco ProdA
14	123	NRU	TX	CSC-50b	CSC-50-blank	14	ITVTYPE	type of intervention article	PRODUCT
15	123	NRU	TX	CSC-50b	CSC-50-blank	15	ITVCONC	intervention concentration	50
16	123	NRU	TX	CSC-50b	CSC-50-blank	16	ITVCONCU	intervention unit	ug/ml
17	123	NRU	TX	CSC-50b	CSC-50-blank	17	STRAIN	Strain/Substrain	NO STRAIN
18	123	NRU	TX	CSC-50b	CSC-50-blank	18	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
19	123	NRU	TX	CSC-50b	CSC-50-blank	19	DUREFID	Smoking Regime	Medium Intensity Regimen
20	123	NRU	TX	CSC-50b	CSC-50-blank	20	SPTOBID	Sponsor defined tobacco identifier	CIG01a
21	123	NRU	TX	CSC-50	CSC-50	1	TRTDMIN	Treatment Duration Minimum	47.5
22	123	NRU	TX	CSC-50	CSC-50	2	TRTDTRG	Treatment Duration Target	48
23	123	NRU	TX	CSC-50	CSC-50	3	TRTDMAX	Treatment Duration Maximum	48.5
24	123	NRU	TX	CSC-50	CSC-50	4	TRTDU	Treatment Duration Unit	HOURS
25	123	NRU	TX	CSC-50	CSC-50	5	INCBTMP	Incubation Temperature	37
26	123	NRU	TX	CSC-50	CSC-50	6	INCBTMPU	Incubation Temperature Unit	C
27	123	NRU	TX	CSC-50	CSC-50	7	WAVELGTH	Spectrophotometer WAVELENGTH IN NANOMETERS	540
28	123	NRU	TX	CSC-50	CSC-50	8	HUMID	Atmospheric Relative Humidity Percent	90
29	123	NRU	TX	CSC-50	CSC-50	9	ATMCO2	Atmospheric CO2 Percent	5
30	123	NRU	TX	CSC-50	CSC-50	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
31	123	NRU	TX	CSC-50	CSC-50	11	EXPTYP	Exposure Type	Air Liquid Interface
32	123	NRU	TX	CSC-50	CSC-50	12	SAMTYP	Sample Type	Whole Smoke Conditioned Media
33	123	NRU	TX	CSC-50	CSC-50	13	INTRVN	Name of the Intervention Article	Tobacco ProdA
34	123	NRU	TX	CSC-50	CSC-50	14	ITVTYPE	type of intervention article	PRODUCT
35	123	NRU	TX	CSC-50	CSC-50	15	ITVCONC	intervention concentration	50
36	123	NRU	TX	CSC-50	CSC-50	16	ITVCONCU	intervention unit	ug/ml
37	123	NRU	TX	CSC-50	CSC-50	17	STRAIN	Strain/Substrain	CHO
38	123	NRU	TX	CSC-50	CSC-50	18	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
39	123	NRU	TX	CSC-50	CSC-50	19	DUREFID	Smoking Regime	Medium Intensity Regimen
40	123	NRU	TX	CSC-50	CSC-50	20	SPTOBID	Sponsor defined tobacco identifier	CIG01a
41	123	NRU	TX	SLS-110	SLS-110	1	TRTDMIN	Treatment Duration Minimum	47.5
42	123	NRU	TX	SLS-110	SLS-110	2	TRTDTRG	Treatment Duration Target	48
43	123	NRU	TX	SLS-110	SLS-110	3	TRTDMAX	Treatment Duration Maximum	48.5
44	123	NRU	TX	SLS-110	SLS-110	4	TRTDU	Treatment Duration Unit	HOURS
45	123	NRU	TX	SLS-110	SLS-110	5	INCBTMP	Incubation Temperature	37
46	123	NRU	TX	SLS-110	SLS-110	6	INCBTMPU	Incubation Temperature Unit	C
47	123	NRU	TX	SLS-110	SLS-110	7	WAVELGTH	Spectrophotometer wavelength in nanometers	540
48	123	NRU	TX	SLS-110	SLS-110	8	HUMID	Atmospheric Relative Humidity Percent	90
49	123	NRU	TX	SLS-110	SLS-110	9	ATMCO2	Atmospheric CO2 Percent	5
50	123	NRU	TX	SLS-110	SLS-110	10	SPTOBID	Sponsor defined tobacco identifier	CIG01a
51	123	NRU	TX	SLS-110	SLS-110	11	EXPTYP	Exposure Type	Air Liquid Interface
52	123	NRU	TX	SLS-110	SLS-110	12	SAMTYP	Sample Type	Liquid
53	123	NRU	TX	SLS-110	SLS-110	13	INTRVN	Name of the Intervention Article	Sodium Laurel Sulfate
54	123	NRU	TX	SLS-110	SLS-110	14	ITVTYPE	type of intervention article	POSITIVE CONTROL
55	123	NRU	TX	SLS-110	SLS-110	15	ITVCONC	intervention concentration	200
56	123	NRU	TX	SLS-110	SLS-110	16	ITVCONCU	intervention unit	ug/ml
57	123	NRU	TX	SLS-110	SLS-110	17	STRAIN	Strain/Substrain	CHO
58	123	NRU	TX	SLS-110	SLS-110	18	SPDEVID	Sponsor defined device identifier	PUFFMASTER3k
59	123	NRU	TX	SLS-110	SLS-110	19	DUREFID	Smoking Regime	Medium Intensity Regimen
60	123	NRU	TX	SLS-110	SLS-110	20	SPTOBID	Sponsor defined tobacco identifier	CIG01a

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Old Version 68

New Version 69

Key

Row

STUDYID

ASSAYID

DOMAIN

SETCD

SET

TXSEQ

TXPARMCD

TXPARM

TXVAL