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

Row	STUDYID	ASSAYIDGNTXAID	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	ASSAYIDGNTXAID	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

Dataset wrap

Name	relref

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 sponsor chose, in this case, to represent the plate number (1 or 2), column (1 - 10), and row (A-G) of the 96-well plate.
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 1-3b.
Rows 10-11:	Show the REFIDs 1-10-G and 2-10-G that indicate two experimental units within the parent Trial Set of 1-3b.

Dataset2

tableid	relref

Row	STUDYID	ASSAYIDGNTXAID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123	NRU	ALL	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

Dataset wrap

Name	gt

Rowcaps

Rows 1-3:	Show the experimental unit data for REFID 1-3-B.
Rows 1-2, 4-5, 10-11, 16-17:	These data (Absorbance Reading and Background Absorbance Reading) are not shown in the sample report table above but included here for completeness of the NRU assay.
Rows 4-6:	Show the experimental unit data for REFID 1-3-C.
Rows 7-9:	Show the data for the entire trial set, REFID=1-3.
Rows 10-12:	Show the experimental unit data for REFID 1-10-G
Rows 13-15:	Show the data for the entire trial set, REFID=1-10
Rows 16-18:	Show the experimental unit data for REFID 2-10-G.
Rows 19-21:	Show the data for the entire trial set, REFID=2-10
Row 22:	Shows the data for the entire assay, REFID=123NRU.

Dataset2

Row

STUDYID

ASSAYIDGNTXAID

DOMAIN

GTSEQ

REFID

GTTESTCD

GTTEST

GTORRES

GTORRESU

GTCOLSRT

GTSTRESC

GTSTRESN

GTSTRESU

1

123

NRU

GT

1

1-3-B

ABSORB

Absorbance Reading

1.7

2

123

NRU

GT

2

1-3-B

BKCABS

Background Corrected Absorbance Reading

1.6

3

123

NRU

GT

3

1-3-B

RELABS

Relative Absorbance Reading

77.7

%

77.7

%

4

123

NRU

GT

4

1-3-C

ABSORB

Absorbance Reading

1.8

5

123

NRU

GT

5

1-3-C

BKCABS

Background Corrected Absorbance Reading

1.7

6

123

NRU

GT

6

1-3-C

RELABS

Relative Absorbance Reading

77.4

7

123

NRU

GT

7

1-3

RELABS

Relative Absorbance Reading

78.2

%

MEAN

78.2

%

8

123

NRU

GT

8

1-3

RELABS

Relative Absorbance Reading

2.9

%

STANDARD DEVIATION

2.9

%

9

123

NRU

GT

9

1-3

RELABS

Relative Absorbance Reading

3.6

COEFFICIENT OF VARIANCE

3.6

10

123

NRU

GT

10

1-10-G

ABSORB

Absorbance Reading

0.7

11

123

NRU

GT

11

1-10-G

BKCABS

Background Corrected Absorbance Reading

0.6

12

123

NRU

GT

11

1-10-G

RELABS

Relative Absorbance Reading

8.57

13

123

NRU

GT

12

1-10

RELABS

Relative Absorbance Reading

8.94

%

MEAN

8.94

14

123

NRU

GT

13

1-10

RELABS

Relative Absorbance Reading

2.72

%

STANDARD DEVIATION

2.72

15

123

NRU

GT

14

1-10

RELABS

Relative Absorbance Reading

30.5

COEFFICIENT OF VARIANCE

30.5

16

123

NRU

GT

15

2-10-G

ABSORB

Absorbance Reading

0.9

17

123

NRU

GT

16

2-10-G

BKCABS

Background Corrected Absorbance Reading

0.8

18

123

NRU

GT

17

2-10-G

RELABS

Relative Absorbance Reading

6.30

19

123

NRU

GT

18

2-10

RELABS

Relative Absorbance Reading

5.91

%

MEAN

5.91

20

123

NRU

GT

19

2-10

RELABS

Relative Absorbance Reading

0.83

%

STANDARD DEVIATION

0.83

21

123

NRU

GT

20

2-10

RELABS

Relative Absorbance Reading

14.1

COEFFICIENT OF VARIANCE

14.1

22

123

NRU

GT

21

123NRU

EC50

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-132

Effective Concentration of 50 Percent Cytotoxicity

123

ug/ml

123

ug/ml

...

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