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This example shows sample raw dataa report table, trial design, and results data for the in vitro Neutral Red Uptake Cytotoxicity Assay. neutral red uptake (NRU) cytotoxicity assay in example study 123.

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

Expand

title	Study 123, Sample from Report Table

The following shows the tabulated data as it is represented example data for study 123 in a report for this studytable. This report includes summary statistics (i.e.g. Average, Standard Deviation, Coeff. Var.)

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

0.046*

0.039*

0.012*

0.030*

0.003*

0.057*

0.032*

0.003*

0.050*

0.044*

0.040*

1-1

030001

A

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

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

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

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

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

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

8

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

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

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 (µg/ml). Effective concentration at 50% cytotoxicity. (using a specific sigmoidal equation = model). (could also be EC20 or EC30, EC70, etc.)

123

Expand

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

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

, average, standard deviation, coefficient variation) for each plate and an EC50 value for the entire assay. In the table below, the light grey shading for plate 1 are values from wells that do not contain the NHK cells. The dark grey shading represents the column and row location within the 96-well plate, and in this example the applicant chose to use these column and row locations to assign their REFID values in the RELREF dataset and GT dataset.

For brevity, the datasets in this example are not comprehensive but are intended to demonstrate a range of proper use.

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)
	Sample ID	Smoke Regime	Replicate Number	Plate 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	A	0.046*	0.046*	0.039*	0.012*	0.030*	0.003*	0.057*	0.032*	0.003*	0.050*	0.044*	0.040*
	030001	Medium	1	1	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 3:	Shows that this study was conducted as a GLP study.
Rows 4-5:	Show the study start date and study title.
Rows 6-7:	Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study.
Row 8:	Shows the applicant's organization.
Row 9:	Shows that the applicant's study reference ID is not applicable.
Rows 10-13:	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).
Row 17:	Shows the study type for this study.
Row 18:	Shows that this study includes a Neutral Red Uptake Assay.
Rows 19-20:	Show that the species is human and the cell line is NHK in this study.

Dataset2

Row	STUDYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123	TS	1		GLPFL	GLP Flag	Y
4	123	TS	1		STSTDTC	Study Start Date	2022-05-25
5	123	TS	1		STITLE	Study Title	Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay
6	123	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7	123	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
8	123	TS	1		APPLCNT	Applicant	Example Applicant Inc.
9	123	TS	1		APREFID	Applicant Study Reference ID		NOT APPLICABLE
10	123	TS	1	1	TSTFNAM	Test Facility Name	Example Test Lab Name
11	123	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
12	123	TS	1	1	TFCNTRY	Test Facility Country	USA
13	123	TS	1	1	STDIR	Study Director	Dr. R. Smith
14	123	TS	1	4	TSTGDNAM	Testing Guideline Name	Publication No. 07-4519
15	123	TS	1	4	TSTGDORG	Testing Guideline Organization	NIH
16	123	TS	1	4	TSTGDVER	Testing Guideline Version	2006-11
17	123	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
18	123	TS	1		GNTXAID	Genetic Toxicology Assay Identifier	NRU
19	123	TS	1		SPECIES	Species	HUMAN
20	123	TS	1		CELLLN	Cell Line	NHK

Dataset wrap

Rowcaps

Rows 1-12:	Show the test conditions for the set with a short name or SETCD value of NRU. The applicant chose this value to represent test conditions for the entire assay.
Rows 13-31:	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. The value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells.
Rows 32-50:	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 51-69:	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.

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 Applicant Inc.

8

123

NRU

TS

1

SPREFID

Sponsor Study Reference ID

NOT APPLICABLE

9

123

NRU

TS

1

TSTFNAM

Test Facility Name

Example ~~Tox~~ Testing Lab Name

10

123

NRU

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

11

123

NRU

TS

1

TFCNTRY

Test Facility Country

USA

12

123

NRU

TS

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

Expand

title	tx.xpt (trial sets)

Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct ~~sponsor~~ applicant designations as specified in the trial design.
During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
Smoke fraction? is this indicator of processing of material from smoke machine..we used Smoke Exposure System - ok?
Incubate cells (37 ºC ±1 ºC, 90% ±10% humidity, and 5% ±1% CO2/air) - these are ranges, do we model for ranges?
- https://ntp.niehs.nih.gov/iccvam/docs/protocols/ivcyto-nhk.pdf

Rows 1-20: Show the values for the

Row

STUDYID

ASSAYID

DOMAIN

SETCD

SET (what sponsor calls it)

TXSEQ

TXPARMCD

TXPARM

TXVAL

1

123

NRU

Dataset2

ROW	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	TX	NRU	NRU_ASSAY	1	IVTDMIN	In vitro Treatment Duration Minimum	47.5
2	123	TX	NRU	NRU_ASSAY	2	IVTDTRG	In vitro Treatment Duration Target	48
3	123	TX	NRU	NRU_ASSAY	3	IVTDMAX	In vitro Treatment Duration Maximum	48.5
4	123	TX	NRU	NRU_ASSAY	4	IVTDU	In vitro Treatment Duration Unit	HOURS
5	123	TX	NRU	NRU_ASSAY	5	INCBTMP	Incubation Temperature	37
6	123	TX	NRU	NRU_ASSAY	6	INCBTMPU	Incubation Temperature Unit	C
7	123	TX	NRU	NRU_ASSAY	7	SWAVENM	Spectrophotometer Wavelength	540
8	123	TX	NRU	NRU_ASSAY	8	ATMRHP	Atmospheric Relative Humidity Percent	90
9	123	TX	NRU	NRU_ASSAY	9	ATMCO2P	Atmospheric CO2 Percent	5
10	123	TX	NRU	NRU_ASSAY	10	SPDEVID	applicant defined device identifier	PUFFMASTER3k
11	123	TX	NRU	NRU_ASSAY	11	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
12	123	TX	NRU	NRU_ASSAY	12	SPTOBID	Applicant-defined tobacco identifier	CIG01a
13	123	TX	CSC-50b	CSC-50-blank	13	IVTDMIN	In vitro Treatment Duration Minimum	47.5
14	123	TX	CSC-50b	CSC-50-blank	14	IVTDTRG	In vitro Treatment Duration Target	48
15	123	TX	CSC-50b	CSC-50-blank	15	IVTDMAX	In vitro Treatment Duration Maximum	48.5
16	123	TX	CSC-50b	CSC-50-blank	16	IVTDU	In vitro Treatment Duration Unit	HOURS
17	123	TX	CSC-50b	CSC-50-blank	17	INCBTMP	Incubation Temperature	37
18	123	TX	CSC-50b	CSC-50-blank	18	INCBTMPU	Incubation Temperature Unit	C
19	123	TX	CSC-50b	CSC-50-blank	19	SWAVENM	Spectrophotometer Wavelength	540
20	123	TX	CSC-50b	CSC-50-blank	20	ATMRHP	Atmospheric Relative Humidity Percent	90
21	123	TX	CSC-50b	CSC-50-blank	21	ATMCO2P	Atmospheric CO2 Percent	5
22	123	TX	CSC-50b	CSC-50-blank	22	SPDEVID	applicant defined device identifier	PUFFMASTER3k
23	123

TX

CSC-50b

CSC-50-blank

1

23

TRTDMINTreatment Duration Minimum47.5

SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
24

2

123

NRU

TX

CSC-50b

CSC-50-blank

2

24

TRTDTRGTreatment Duration Target48

SPTOBID	Applicant-defined tobacco identifier	CIG01a
25

3

123

NRU

TX

CSC-50b

CSC-50-blank

3

25

TRTDMAXTreatment Duration Maximum48.5

EXPTYP	Exposure Type	Air Liquid Interface
26

4

123

NRU

TX

CSC-50b

CSC-50-blank

4

26

TRTDUTreatment Duration UnitHOURS

SAMTYP	Sample Type	Whole Smoke Conditioned Media
27

5

123

NRU

TX

CSC-50b

CSC-50-blank

5

27

INCBTMPIncubation Temperature37

ITVNAM	Name of the Intervention Article	Tobacco ProdA
28

6

123

NRU

TX

CSC-50b

CSC-50-blank

6

28

INCBTMPUIncubation Temperature UnitC

ITVTYPE	Intervention Article Type	PRODUCT
29

7

123

NRU

TX

CSC-50b

CSC-50-blank

7

29

WAVELGTHSpectrophotometer WAVELENGTH IN NANOMETERS540

ITVCONC	Intervention Article Concentration	50
30	123

8123NRU

TX

CSC-50b

CSC-50-blank

8

30

HUMIDAtmospheric Relative Humidity Percent90

ITVCONCU	Intervention Article Concentration Unit	ug/ml
31

9

123

NRU

TX

CSC-50b

CSC-50-blank

9

31

ATMCO2Atmospheric CO2 Percent510123

CELLLN	Cell Line	NOT APPLICABLE
32	123

NRU

TX

CSC-

50b

50

CSC-50

-blank

10

32

SPTOBID

Sponsor defined tobacco identifier

CIG01a

IVTDMIN	In vitro Treatment Duration Minimum	47.5
33	123

11123NRU

TX

CSC-

50b

50

CSC-50

-blank

11

33

EXPTYP

Exposure Type

Air Liquid Interface

IVTDTRG	In vitro Treatment Duration Target	48
34

12

123

NRU

TX

CSC-

50b

50

CSC-50

-blank

12

34

SAMTYPSample TypeWhole Smoke Conditioned Media

IVTDMAX	In vitro Treatment Duration Maximum	48.5
35

13

123

NRU

TX

CSC-

50b

50

CSC-50

-blank

13

35

INTRVNName of the Intervention ArticleTobacco ProdA14123

IVTDU	In vitro Treatment Duration Unit	HOURS
36	123

NRU

TX

CSC-

50b

50

CSC-50

-blank15123NRU

14ITVTYPE

(CT e.g, Product, positive control, negative control, vehicle control, solvent control)

type of intervention articlePRODUCT

36	INCBTMP	Incubation Temperature	37
37	123

TX

CSC-

50b

50

CSC-50

-blank

15

37

ITVCONCintervention concentration5016123

INCBTMPU	Incubation Temperature Unit	C
38	123

NRU

TX

CSC-

50b

50

CSC-50

-blank

16

38

ITVCONCU

SWAVENM

intervention unitug/ml

Spectrophotometer Wavelength	540
39

17

123

NRU

TX

CSC-

50b

50

CSC-50

-blank

17

39

STRAINStrain/SubstrainNO STRAIN

ATMRHP	Atmospheric Relative Humidity Percent	90
40	123

18123NRU

TX

CSC-

50b

50

CSC-50

-blank

18

40

SPDEVIDSponsor defined device identifierPUFFMASTER3k

ATMCO2P	Atmospheric CO2 Percent	5
41

19

123

NRU

TX

CSC-

50b

50

CSC-50

-blank

19

41

DUREFIDSmoking RegimeMedium Intensity Regimen

SPDEVID	applicant defined device identifier	PUFFMASTER3k
42

20

123

NRU

TX

CSC-

50b

50

CSC-50

-blank

20

42

SPTOBID

Sponsor defined tobacco identifier

CIG01a

SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
43

1

123

NRU

TX

CSC-50

1

43

TRTDMINTreatment Duration Minimum47.5

SPTOBID	Applicant-defined tobacco identifier	CIG01a
44

2

123

NRU

TX

CSC-50

2

44

TRTDTRGTreatment Duration Target48

EXPTYP	Exposure Type	Air Liquid Interface
45

3

123

NRU

TX

CSC-50

3

45

TRTDMAXTreatment Duration Maximum48.5

SAMTYP	Sample Type	Whole Smoke Conditioned Media
46

4

123

NRU

TX

CSC-50

4

46

TRTDUTreatment Duration UnitHOURS

ITVNAM	Intervention Article Name	Tobacco ProdA
47

5

123

NRU

TX

CSC-50

5

47

INCBTMPIncubation Temperature376123

ITVTYPE	Intervention Article Type	PRODUCT
48	123

NRU

TX

CSC-50

6

48

INCBTMPUIncubation Temperature UnitC

ITVCONC	Intervention Article Concentration	50
49

7

123

NRU

TX

CSC-50

7

49

WAVELGTHSpectrophotometer WAVELENGTH IN NANOMETERS540

ITVCONCU	Intervention Article Concentration Unit	ug/ml
50	123

8123NRU

TX

CSC-50

8

50

HUMIDAtmospheric Relative Humidity Percent90

CELLLN	Cell Line	NHK
51

9

123

NRU

TX

CSC

SLS-

50

110

CSC

SLS-

50

110

9

51

ATMCO2Atmospheric CO2 Percent5

IVTDMIN	In vitro Treatment Duration Minimum	47.5
52

10

123

NRU

TX

CSC

SLS-

50

110

CSC

SLS-

50

110

10

52

SPTOBID

Sponsor defined tobacco identifier

CIG01a

IVTDTRG	In vitro Treatment Duration Target	48
53

11

123

NRU

TX

CSC

SLS-

50

110

CSC

SLS-

50

110

11

53

EXPTYP

Exposure Type

Air Liquid Interface

IVTDMAX	In vitro Treatment Duration Maximum	48.5
54

12

123

NRU

TX

CSC

SLS-

50

110

CSC

SLS-

50

110

12

54

SAMTYPSample TypeWhole Smoke Conditioned Media

IVTDU	In vitro Treatment Duration Unit	HOURS
55

13

123

NRU

TX

CSC

SLS-

50

110

CSC

SLS-

50

110

13

55

INTRVNName of the Intervention ArticleTobacco ProdA

INCBTMP	Incubation Temperature	37
56

14

123

NRU

TX

CSC

SLS-

50

110

CSC

SLS-

50

110

14ITVTYPE

(CT e.g, Product, positive control, negative control, vehicle control, solvent control)

type of intervention articlePRODUCT

56	INCBTMPU	Incubation Temperature Unit	C
57	123	TX	SLS-110	SLS-110	57	SWAVENM	Spectrophotometer Wavelength	540
58	123	TX	SLS-110	SLS-110	58	ATMRHP	Atmospheric Relative Humidity Percent	90
59	123	TX	SLS-110	SLS-110	59	ATMCO2P	Atmospheric CO2 Percent	5
60	123	TX	SLS-110	SLS-110	60	SPDEVID	applicant

15123NRUTXCSC-50CSC-5015ITVCONCintervention concentration5016123NRUTXCSC-50CSC-5016ITVCONCUintervention unitug/ml17123NRUTXCSC-50CSC-5017STRAINStrain/SubstrainCHO18123NRUTXCSC-50CSC-5018SPDEVIDSponsor

defined device identifier

PUFFMASTER3k

19

61

123

NRU

TX

CSC

SLS-

50

110

CSC

SLS-

50

110

19

61

DUREFID

SMKRGM

Smoking

RegimeMedium Intensity Regimen

Regimen	MEDIUM INTENSITY REGIMEN
62

20

123

NRU

TX

CSC

SLS-

50

110

CSC

SLS-

50

110

20

62

SPTOBID

Sponsor

Applicant-defined tobacco identifier

CIG01a

21

63

123

NRU

TX

SLS-110

1

63

TRTDMINTreatment Duration Minimum47.5

EXPTYP	Exposure Type	Air Liquid Interface
64

22

123

NRU

TX

SLS-110

2

64

TRTDTRGTreatment Duration Target48

SAMTYP	Sample Type	Liquid
65

23

123

NRU

TX

SLS-110

3

65

TRTDMAXTreatment Duration Maximum48.5

ITVNAM	Intervention Article Name	Sodium Laurel Sulfate
66

24

123

NRU

TX

SLS-110

4

66

TRTDUTreatment Duration UnitHOURS

ITVTYPE	Intervention Article Type	POSITIVE CONTROL
67

25

123

NRU

TX

SLS-110

5

67

INCBTMPIncubation Temperature37

ITVCONC	Intervention Article Concentration	110
68	123

26123NRU

TX

SLS-110

6

68

INCBTMPU

ITVCONCU

Intervention Article Concentration

Incubation Temperature

Unit

C

ug/ml

27

69

123

NRU

TX

SLS-110

7WAVELGTHSpectrophotometer WAVELENGTH IN NANOMETERS54028123NRUTXSLS-110SLS-1108HUMIDAtmospheric Relative Humidity Percent9029123NRUTXSLS-110SLS-1109ATMCO2Atmospheric CO2 Percent530123NRUTXSLS-110SLS-11010SPTOBID

Sponsor defined tobacco identifier

CIG01a31123NRUTXSLS-110SLS-11011EXPTYP

Exposure Type

Air Liquid Interface32123NRUTXSLS-110SLS-11012SAMTYPSample TypeLiquid33123NRUTXSLS-110SLS-11013INTRVNName of the Intervention ArticleSodium Laurel Sulfate34123NRUTXSLS-110SLS-11014ITVTYPE

(CT e.g, Product, positive control, negative control, vehicle control, solvent control)

type of intervention articlePOSITIVE CONTROL35123NRUTXSLS-110SLS-11015ITVCONCintervention concentration20036123NRUTXSLS-110SLS-11016ITVCONCUintervention unitug/ml37123NRUTXSLS-110SLS-11017STRAINStrain/SubstrainCHO38123NRUTXSLS-110SLS-11018SPDEVIDSponsor defined device identifierPUFFMASTER3k39123NRUTXSLS-110SLS-11019DUREFIDSmoking RegimeMedium Intensity Regimen40123NRUTXSLS-110SLS-11020SPTOBID

Sponsor defined tobacco identifier

CIG01a Expand

title	relref.xpt

Image Removed

relref.xpt

Row

STUDYID

ASSAYID

SETCD

REFTYPE

REFID

PARENT

LEVEL

1123NRUALLASSAY123NRU1

69

CELLLN

Cell Line

NHK

Dataset wrap

Name	relref

The applicant chose to define the REFID values to indicate the Plate, the Column, and the Row of the wells of the 96-well plate in use, such that the well on plate 2, column 10, row G would assigned a REFID of 2-10-G.

Rowcaps

Row 1:	Shows the REFID of 123NRU that indicates the entire assay.
Rows 2-4:	Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3, 1-10, 2-10) which have LVLDESC of OBSERVATIONAL SUMMARY. If this study had recorded summary statistics for an entire trial set (e.g., across both plates for the same dose level), there would be an additional REFID for the trial set (with a LVLDESC of TRIAL SET).
Rows 5-6:	Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units that are also observational units within the SETCD of CSC-50b that have the parent REFID of 123NRU.
Rows 7-8:	Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units that are also observational units within the SETCD of CSC-50 that have the parent REFID of 1-3.
Row 9:	Shows the REFID of 1-10-G that indicates the experimental unit that is also an observational unit within the SETCD of SLS-110 that has the parent REFID of 1-10.
Row 10:	Shows the REFID of 2-10-G that indicates the experimental unit that is also an observational unit within the SETCD of SLS-110 that has the parent REFID of 2-10.

Dataset2

tableid	relref

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

REFID

Dataset wrap

Name	gt

Certain data (Absorbance Reading and Background Corrected Absorbance Reading) are not shown in the sample report table above but are included here for completeness of the NRU assay.

Rowcaps

Rows 1-3:	Show the experimental unit data for GTREFID 1-3-B.
Rows 4-6:	Show the experimental unit data for GTREFID 1-3-C.
Rows 7-9:	Show the data for the entire trial set, GTREFID=1-3.
Rows 10-12:	Show the experimental unit data for GTREFID 1-10-G
Rows 13-15:	Show the data for the entire trial set, GTREFID=1-10
Rows 16-18:	Show the experimental unit data for GTREFID 2-10-G.
Rows 19-21:	Show the data for the entire trial set, GTREFID=2-10
Row 22:	Shows the data for the entire assay, GTREFID=123NRU.

Dataset2

Row	STUDYID	DOMAIN	GTSEQ	GTREFID

2

123

NRU

CSC-50b

TRIAL SET

1-3b

123NRU

2

3

123

NRU

CSC-50b

EXPERIMENTAL UNIT

1-3-A

1-3b

3

5

123

NRU

CSC-50b

EXPERIMENTAL UNIT

1-3-H

1-3b

3

6

123

NRU

CSC-50

TRIAL SET

1-3

123NRU

2

7

123

NRU

CSC-50

EXPERIMENTAL UNIT

1-3-B

1-3

3

8

123

NRU

CSC-50

EXPERIMENTAL UNIT

1-3-C

1-3

3

9

123

NRU

SLS-110

TRIAL SET

1-10

123NRU

2

10

123

NRU

SLS-110

TRIAL SET

2-10

123NRU

2

11

123

NRU

SLS-110

EXPERIMENTAL UNIT

1-10-G

1-10

3

12

123

NRU

SLS-110

EXPERIMENTAL UNIT

2-10-G

2-10

3

Expand

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).

row 161: This shows the EC50 result value for the entire assay (the SETCD, EUID, and OBUID are null).

Rows 1, 4: These data are shown in the above data report table but included here for completeness.

Row

STUDYID

ASSAYID

DOMAIN

GTSEQ

	GTTESTCD	GTTEST	GTORRES	GTORRESU	GTCOLSRT

(coll. summ. result type)

	GTSTRESC	GTSTRESN	GTSTRESU
1	123

NRU

GT

1

1-3-B

ABSORB

Absorbance Reading

1.7

(0.0 - 2.0)

			1.7	1.7
2	123

NRU

	GT	2	1-3-B	BKCABS	Background Corrected Absorbance Reading	1.6			1.6	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

(0.0 - 2.0)

			1.8	1.8
5	123

NRU

GT	5	1-3-C	BKCABS	Background Corrected Absorbance Reading	1.7			1.7	1.7
6	123

NRU

GT	6	1-3-C	RELABS	Relative Absorbance Reading	77.4			77.4	77.4
7	123

NRU

GT

7

1-3

RELABS

Relative Absorbance

Reading

Reading	78.2	%	MEAN	78.2	78.2	%
8	123	GT	8	1-3	RELABS	Relative Absorbance

Reading

Reading	2.9	%	STANDARD DEVIATION	2.9	2.9	%
9	123	GT	9	1-3	RELABS	Relative Absorbance

Reading

Reading	3.6		COEFFICIENT OF VARIANCE	3.6	3.6
10	123	GT	10	1-10-G	ABSORB	Absorbance Reading	0.7	0.7	0.7
11	123	GT	11	1-10-G	BKCABS	Background Corrected Absorbance Reading	0.6	0.6	0.6

80


12	123

NRU

GT

11

12

1-10-G

RELABS

Relative Absorbance Reading

8.57

8.

578.57

57	8.57
13	123	GT	13

12

1-10

RELABS

Relative Absorbance Reading

8.94

%

MEAN

8.94

13


14	123	GT	14	1-10	RELABS	Relative Absorbance Reading	2.72	%	STANDARD DEVIATION	2.72	2.72

...


15	123	GT	15

14

1-10

RELABS

Relative Absorbance Reading

30.5

COEFFICIENT OF VARIANCE

30.5

15


16	123	GT	16	2-10-G	ABSORB	Absorbance Reading	0.9

16


17	123	GT	17	2-10-G	BKCABS	Background Corrected Absorbance Reading	0.8

160


18	123

NRU

GT

17

18	2-10-G	RELABS	Relative Absorbance Reading	6.30			6.30	6.30
19	123

NRU

GT

18

19	2-10	RELABS	Relative Absorbance Reading	5.91	%	MEAN	5.91	5.91
20	123

NRU

GT

19

20	2-10	RELABS	Relative Absorbance Reading	0.83	%	STANDARD DEVIATION	0.83	0.83
21	123

NRU

GT

20

21

2-10

RELABS

Relative Absorbance Reading

14.1

COEFFICIENT OF VARIANCE

14.1

161


22	123

NRU

GT

21

22

123NRU

EC50

EC50CYTX

Effective Concentration of 50 Percent Cytotoxicity

123

ug/ml

123

ug/ml

Page tree

Versions Compared

Old Version 57

New Version Current

Key

SET (what sponsor calls it)

(CT e.g, Product, positive control, negative control, vehicle control, solvent control)

(CT e.g, Product, positive control, negative control, vehicle control, solvent control)

(CT e.g, Product, positive control, negative control, vehicle control, solvent control)