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title	Study 123, Report Table

The following shows the tabulated data as it is represented in a report for this study. This report includes summary statistics (e.g. Average, Standard Deviation, Coeff. Var.); however, statistics are not included in the SEND standard and will not be represented in the SEND domains example.

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)

Run-Port Number

Sample ID

Smoke Fraction

Replicate Number

Plate Number

Well Number

Relative Assay Plate Absorbance Readings

Cigarette Smoke Condensate (µg/mL)

SLS (µg/mL)

EC50 (µg/ml)

0

10

50

75

100

120

140

160

200

110

200

0

1-1

030001

A

1

100

0.046

83

0.046

0.039

56

0.

7

012

29

0.

5

030

13

0.003

0.057

8

0.

57

032

4

0.

44

003

1

0.

76

050

13

0.

7

044

0.

547

040
1-1	030001	A	1	1	2	0.048	107	77.7	65.7	30.2	15.6	9.79	5.41	2.49	8.09	0.791	0.014
1-1	030001	A	1	1	3	0.005	98.6	77.4	57.7	35.8	8.09	7.36	3.22	0.791	6.38	0.061	0.050
1-1	030001	A	1	1	4	0.049	94.9	81.5	38.2	31.2	7.60	5.17	3.22	0.791	5.17	0.304	0.017
1-1	030001	A	1	1	5	0.047	111	78.1	64.5	32.9	8.82	5.90	2.74	1.28	10.3	0.547	0.011
1-1	030001	A	1	1	6	0.032	96.6	76.2	48.0	26.8	7.84	4.20	2.74	1.52	8.09	4.93	0.022
1-1	030001	A	1	1	7	0.044	105	77.9	58.2	28.3	8.09	4.68	1.76	0.547	8.57	1.76	0.056
1-1	030001	A	1	1	8	0.056

95

0.

2

013

74

0.040

0.008

47

0.

2

013

24

0.

4

002

8

0.

57

029

3

0.

71

018

3

0.

47

006

0.

304

016

11

0.

2

024

0.

791

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
EC50 (µg/ml). Effective concentration at 50% cytotoxicity. (using a specific sigmoidal equation = model). (could also be EC20 or EC30, EC70, etc.)																123
1-1	030001	A	1	2	1	93.4	74.0	56.0	35.1	11.8	8.70	5.10	1.98	5.34	1.02
1-1	030001	A	1	2	2	102	75.2	53.3	35.1	11.8	7.74	5.58	3.66	5.34	1.02
1-1	030001	A	1	2	3	107	79.0	55.0	26.5	10.1	6.06	3.66	1.74	7.02	0.780
1-1	030001	A	1	2	4	104	80.2	55.3	29.8	8.94	3.90	3.66	1.50	6.30	0.780
1-1	030001	A	1	2	5	101	75.7	54.1	26.7	4.86	4.38	1.26	1.02	6.30	1.02
1-1	030001	A	1	2	6	110	85.7	67.7	26.0	5.34	4.62	3.42	1.50	6.30	0.540
1-1	030001	A	1	2	7	104	77.8	64.9	27.7	8.22	3.18	2.46	1.02	6.30	0.780
1-1	030001	A	1	2	8	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 (mg/ml). Effective concentration at 50% cytotoxicity																130

to.xpt

do.xpt

di.xpt

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

Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
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
Sponsor should be "applicant", how do we represent this? In text explanation in the IG? In definition in CT/Parmcd/Parm? ** Need to have CT discussion, include Erin M.**
TK6, human keratinocyte, is this the "test system"?
Can we draft a starting list of Study Types and Sub Types to submit to CT now?
Is there a dictionary of species and/or strain that we would use? (see example)

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~~ Applicant's Organization	Example Applicant Inc.
8	123	NRU	TS	1		SPREFID	~~Sponsor's~~ Applicant's Study Reference ID		NOT APPLICABLE
9	123	NRU	TS	1	1	TSTFNAM	Test Facility Name	Example ~~Tox~~ Testing 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	Salmonella enterica
19	123	NRU	TS	1		??	Test System??	TK6 Normal Human Keratinocyte

...

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title	gt.xpt (similar to LB)

cells growing in plate, treat cells in the plate, then add NRU dye, then extract NRU (the OBUID) dye and transfer to another plate (put in spectrophotometer & read).

.

*** Lou Ann:

new pictures with blank media on perimeter

Data values in gt.xpt will be from 2b (1a), 2c (2b), 10g (not 10H) on both plates

Row	STUDYID	ASSAYID	DOMAIN	SETCD	EUID

ENID

GTSEQ	GTTESTCD	GTTEST	GTORRES	GTORRESU	GTCOLSRT (coll. summ. result type)	GTSTRESC	GTSTRESN	GTSTRESU
123	NRU	GT	1-2-B	1-2-B	1-2-B	1	ABSORB	Absorbance Reading	1.7 (0.0 - 2.0)		1.7	1.7
123	NRU	GT			1-2-B	1	BKCABS	Background Corrected Absorbance Reading	1.6		1.6	1.6
123	NRU	GT			1-2-B	1	RELABS	Relative Absorbance Reading	77.7	%	77.7	77.7	%
123	NRU	GT

1-2-B

				1	EC50	Effective Concentration of 50 Percent Cytotoxicity	123	ug/ml		123	123	ug/ml
	123	NRU	GT		1-2-C		1	RELABS	Relative Absorbance Reading	77.4			77.4	77.4
...
80	123	NRU	GT		1-11-G		1	RELABS	Relative Absorbance Reading	8.57	ug/ml		8.57	8.57	ug/ml
...					...
160	123	NRU	GT		2-11-G		1	RELABS	Relative Absorbance Reading	6.30	ug/ml		6.30	6.30	ug/ml

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