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Comment: TOBA-601

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title	Sample from Report Table

The following shows example data for study 123 in a report table. This report includes summary statistics (i.e., average, standard deviation, coefficient variation) for each plate and an EC50

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-593

value for the entire assay. The grey cells in plate 1 are cells that do not contain the NHK cells.

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)

Sample ID

Smoke Regime

Replicate Number

Plate Number

Well Number

		Relative Assay Plate Absorbance Readings
		Cigarette Smoke Condensate (µg/mL)								SLS (µg/mL)			EC50 (µg/ml)
Well Column:	1	2	3	4	5	6	7	8	9	10	11	12
Well Row:	0	10	50	75	100	120	140	160	200	110	200	0
	030001	Medium	1	1

0.046*

0.039*

0.012*

0.030*

0.003*

0.057*

0.032*

0.003*

0.050*

0.044*

0.040*

030001

Medium

B	0.048*	107	77.7	65.7	30.2	15.6	9.79	5.41	2.49	8.09	0.791	0.014*
	030001	Medium	1	1

C	0.005*	98.6	77.4	57.7	35.8	8.09	7.36	3.22	0.791	6.38	0.061	0.050*
	030001	Medium	1	1

D	0.049*	94.9	81.5	38.2	31.2	7.60	5.17	3.22	0.791	5.17	0.304	0.017*
	030001	Medium	1	1

E	0.047*	111	78.1	64.5	32.9	8.82	5.90	2.74	1.28	10.3	0.547	0.011*
	030001	Medium	1	1

F	0.032*	96.6	76.2	48.0	26.8	7.84	4.20	2.74	1.52	8.09	4.93	0.022*
	030001	Medium	1	1

G	0.044*	105	77.9	58.2	28.3	8.09	4.68	1.76	0.547	8.57	1.76	0.056*
	030001	Medium	1	1

H	0.056*	0.013*	0.040*	0.008*	0.013*	0.002*	0.029*	0.018*	0.006*	0.016*	0.024*	0.046*
Average							101	78.2	54.5	29.9	9.70	6.17	3.37	1.19	8.94	1.22
Std. Dev.							6	2.9	9.4	3.6	2.95	2.19	1.12	0.72	2.72	1.58
Coeff. Var.							5.8	3.6	17.2	11.9	30.4	35.5	33.1	61.0	30.5	129.9
*media without cells
	030001	Medium	1	2

A		93.4	74.0	56.0	35.1	11.8	8.70	5.10	1.98	5.34	1.02
	030001	Medium	1	2

B		102	75.2	53.3	35.1	11.8	7.74	5.58	3.66	5.34	1.02
	030001	Medium	1	2

C		107	79.0	55.0	26.5	10.1	6.06	3.66	1.74	7.02	0.780
	030001	Medium	1	2

D		104	80.2	55.3	29.8	8.94	3.90	3.66	1.50	6.30	0.780
	030001	Medium	1	2

E		101	75.7	54.1	26.7	4.86	4.38	1.26	1.02	6.30	1.02
	030001	Medium	1	2

F		110	85.7	67.7	26.0	5.34	4.62	3.42	1.50	6.30	0.540
	030001	Medium	1	2

G		104	77.8	64.9	27.7	8.22	3.18	2.46	1.02	6.30	0.780
	030001	Medium	1	2

H	103	71.6	58.9	25.5	9.42	4.14	3.90	1.26	4.38	0.780
Average						103	77.4	58.1	29.0	8.82	5.34	3.63	1.71	5.91	0.840
Std. Dev.						5	4.4	5.3	4.0	2.63	1.97	1.37	0.86	0.83	0.170
Coeff. Var.						4.6	5.6	9.2	13.6	29.8	36.9	37.6	50.0	14.1	20.2
EC50 (µg/ml). Effective concentration at 50% cytotoxicity. (using a specific sigmoidal equation = model).																123

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 Type	In Vitro Neutral Red Uptake
19	123	NRU	TS	1		SPECIES	Species	HUMAN
20	123	NRU	TS	1		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 - 1012), 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 1-3.
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	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

...

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