Page History

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Dataset wrap

Rowcaps

Rows 1-2:

Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this example study.

Row 8:

Shows that the applicant's

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-356

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.

Rows 14-16:

Show that TSGRPID (TSGRPID=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-56

Dataset2

Row	STUDYID	GNTXAID	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		APPLCNT	Applicant Organization	Example Applicant Inc.
8	123	NRU	TS	1		APREFID	Applicant 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	4	TSTGDNAM	Testing Guideline Name	Publication No. 07-4519
15	123	NRU	TS	1	4	TSTGDORG	Testing Guideline Organization	NIH
16	123	NRU	TS	1	4	TSTGDVER	Testing Guideline Version	2006-11
17	123	NRU	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
18	123	NRU	TS	1		SSSTYP	Study Sub TypeIn Vitro Neutral Red Uptake	IN VITRO NEUTRAL RED UPTAKE
19	123	NRU	TS	1		SPECIES	Species	HUMAN
20	123	NRU	TS	1		CELLLN	Cell Line	NHK

Dataset wrap

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-279

Rowcaps

Rows 1-12:	Show the test conditions for the set with a short name or SETCD value of ALLNRU. The applicant chose this value to represent test conditions for the entire assay.
Rows 13-20:	Show the test conditions for the set with a short name or SETCD value of CSC-50b. The applicant chose this value to represent plate number 1, well row A, well column 3, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123.
Row 20:	Shows the value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells.
Rows 21-28:	Show the test conditions for the set with a short name or SETCD value of CSC-50. The applicant chose this value to represent plate number 1, well rows B-G, well column 3 and plate number 2, well rows A-H, well column 3. These all have the concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123.
Rows 29-36:	Show the test conditions for the set with a short name or SETCD value of SLS-110. The applicant chose this value to represent plate number 1, well rows B-G, well column 10, and plate number 2, well rows A-H, well column 10. These all have the concentration of 110µg/mLof sodium laurel sulfate as shown in the report table for study 123.

Dataset2

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	1	IVTDMIN	In vitro Treatment Duration Minimum	47.5
2	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	2	IVTDTRG	In vitro Treatment Duration Target	48
3	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	3	IVTDMAX	In vitro Treatment Duration Maximum	48.5
4	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	4	IVTDU	In vitro Treatment Duration Unit	HOURS
5	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	5	INCBTMP	Incubation Temperature	37
6	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	6	INCBTMPU	Incubation Temperature Unit	C
7	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	7	SWAVENM	Spectrophotometer Wavelength	540
8	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	8	ATMRHP	Atmospheric Relative Humidity Percent	90
9	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	9	ATMCO2P	Atmospheric CO2 Percent	5
10	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	10	SPDEVID	applicant defined device identifier	PUFFMASTER3k
11	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	11	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
12	123	NRU	TX	ALLNRU	ALLNRU_ASSAY	12	SPTOBID	Applicant-defined tobacco identifier	CIG01a
13	123	NRU	TX	CSC-50b	CSC-50-blank	13	PSETCD	Parent Set Code	ALLNRU
14	123	NRU	TX	CSC-50b	CSC-50-blank	14	EXPTYP	Exposure Type	Air Liquid Interface
15	123	NRU	TX	CSC-50b	CSC-50-blank	15	SAMTYP	Sample Type	Whole Smoke Conditioned Media
16	123	NRU	TX	CSC-50b	CSC-50-blank	16	ITVNAM	Name of the Intervention Article	Tobacco ProdA
17	123	NRU	TX	CSC-50b	CSC-50-blank	17	ITVTYPE	Intervention Article Type	PRODUCT
18	123	NRU	TX	CSC-50b	CSC-50-blank	18	ITVCONC	Intervention Article Concentration	50
19	123	NRU	TX	CSC-50b	CSC-50-blank	19	ITVCONCU	Intervention Article Concentration Unit	ug/ml
20	123	NRU	TX	CSC-50b	CSC-50-blank	20	CELLLN	Cell Line	NOT APPLICABLE
21	123	NRU	TX	CSC-50	CSC-50	21	PSETCD	Parent Set Code	ALLNRU
22	123	NRU	TX	CSC-50	CSC-50	22	EXPTYP	Exposure Type	Air Liquid Interface
23	123	NRU	TX	CSC-50	CSC-50	23	SAMTYP	Sample Type	Whole Smoke Conditioned Media
24	123	NRU	TX	CSC-50	CSC-50	24	ITVNAM	Intervention Article Name	Tobacco ProdA
25	123	NRU	TX	CSC-50	CSC-50	25	ITVTYPE	Intervention Article Type	PRODUCT
26	123	NRU	TX	CSC-50	CSC-50	26	ITVCONC	Intervention Article Concentration	50
27	123	NRU	TX	CSC-50	CSC-50	27	ITVCONCU	Intervention Article Concentration Unit	ug/ml
28	123	NRU	TX	CSC-50	CSC-50	28	CELLLN	Cell Line	NHK
29	123	NRU	TX	SLS-110	SLS-110	29	PSETCD	Parent Set Code	ALLNRU
30	123	NRU	TX	SLS-110	SLS-110	30	EXPTYP	Exposure Type	Air Liquid Interface
31	123	NRU	TX	SLS-110	SLS-110	31	SAMTYP	Sample Type	Liquid
32	123	NRU	TX	SLS-110	SLS-110	32	ITVNAM	Intervention Article Name	Sodium Laurel Sulfate
33	123	NRU	TX	SLS-110	SLS-110	33	ITVTYPE	Intervention Article Type	POSITIVE CONTROL
34	123	NRU	TX	SLS-110	SLS-110	34	ITVCONC	Intervention Article Concentration	110
35	123	NRU	TX	SLS-110	SLS-110	35	ITVCONCU	Intervention Article Concentration Unit	ug/ml
36	123	NRU	TX	SLS-110	SLS-110	36	CELLLN	Cell Line	NHK

Dataset wrap

Name	relref

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-280

Rowcaps

Row 1:	Shows the REFID of 123NRU that indicates the entire assay.
Rows 2, 5, 8, 9:	Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3b, 1-3, 1-10, 2-10).
Rows 3-4, 6-7, 10-11:	Show REFID values that the applicant chose, in this case, to represent the plate number (1 or 2), column (1 - 12), and row (A-G) of the 96-well plates.
Rows 3-4:	Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units within the parent trial set of 1-3b.
Rows 6-7:	Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units within the parent trial set of 1-3.
Row 10:	Shows the REFID of 1-10-G that indicates the experimental unit within the parent trial set of 1-10.
Row 11:	Shows the REFID of 2-10-G that indicates the experimental unit within the parent trial set of 2-10.

Dataset2

tableid	relref

Row	STUDYID	GNTXAID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123	NRU	ALLNRU	123NRU		1	ASSAY
2	123	NRU	CSC-50b	1-3b	123NRU	2	TRIAL SET
3	123	NRU	CSC-50b	1-3-A	1-3b	3	EXPERIMENTAL UNIT
4	123	NRU	CSC-50b	1-3-H	1-3b	3	EXPERIMENTAL UNIT
5	123	NRU	CSC-50	1-3	123NRU	2	TRIAL SET
6	123	NRU	CSC-50	1-3-B	1-3	3	EXPERIMENTAL UNIT
7	123	NRU	CSC-50	1-3-C	1-3	3	EXPERIMENTAL UNIT
8	123	NRU	SLS-110	1-10	123NRU	2	TRIAL SET
9	123	NRU	SLS-110	2-10	123NRU	2	TRIAL SET
10	123	NRU	SLS-110	1-10-G	1-10	3	EXPERIMENTAL UNIT
11	123	NRU	SLS-110	2-10-G	2-10	3	EXPERIMENTAL UNIT

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