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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.

Well

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.), 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

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)

Run-Port Number

Sample ID

Smoke Fraction

Replicate Number

Plate Number

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

1-1


	030001

Medium

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

Medium

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

Medium

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

Medium

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

Medium

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


	030001	Medium

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

Medium

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

Medium

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

1-1

030001

Medium

93.4

74.0

56.0

35.1

11.8

8.70

5.10

1.98

5.34

1.02

1-1


	030001

Medium

102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02

1-1


	030001

Medium

107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780

1-1


	030001

Medium

104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780

1-1


	030001

Medium

101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02

1-1


	030001

Medium

110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540

1-1

030001


	030001	Medium

104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780

1-1


	030001

Medium

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).

(could also be EC20 or EC30, EC70, etc.)

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.

Expand

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

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

123

NRU

GLPTYP

Good Laboratory Practice Type

FDA

123

NRU

GLPTYP

Good Laboratory Practice Type

OECD

123

NRU

Dataset2

Row	STUDYID	DOMAIN	TSSEQ	TSPARMCD	TSPARM	TSVAL
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

NRU

STITLE

Study Title

Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay


6	123

NRU

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0


7	123

NRU

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30


8	123

NRU

SSPONSOR

APPLCNT

Sponsor Organization

Applicant

Example Applicant Inc.


9	123

NRU

SPREFID

APREFID

Sponsor

Applicant Study Reference ID

NOT APPLICABLE

123

NRU

TSTFNAM

Test Facility Name

Example

~~Tox~~ Testing

Test Lab Name


11	123

NRU

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000


12	123

NRU

TFCNTRY

Test Facility Country

USA


13	123

NRU

STDIR

Study Director

Dr. R. Smith


14	123

NRU

GLPFLGLP FlagY

4	TSTGDNAM	Testing Guideline Name	Publication No. 07-4519
15

123

NRU

ASTDAssay Standard

TSTGDORG

Testing Guideline Organization

NIH

Publication No. 07-4519


16

123

NRU

ASTDV

TSTGDVER

Testing Guideline

Assay Standard

Version

2006-11


17	123

NRU

SSTYP

Study Type

GENOTOXICITY IN VITRO


18	123

NRU

SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake

	GNTXAID	Genetic Toxicology Assay Identifier	NRU
19

123

NRU

SPECIES

Species

Hamster

HUMAN


20	123

NRU

TESTSYS

CELLLN

Test System

Cell Line

CHO

NHK

NRU

Expanddataset-wrap

title	tx.xpt (trial sets)

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.

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

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

123

NRU

CSC-50b

CSC-50-blank

TRTDMIN

Treatment Duration Minimum

47.5

123

NRU

CSC-50b

CSC-50-blank

TRTDTRG

Treatment Duration Target

123

NRU

CSC-50b

CSC-50-blank

TRTDMAX

Treatment Duration Maximum

48.5

123

NRU

CSC-50b

CSC-50-blank

TRTDU

Treatment Duration Unit

HOURS

123

NRU

CSC-50b

CSC-50-blank

INCBTMP

Incubation Temperature

123

NRU

CSC-50b

CSC-50-blank

INCBTMPU

Incubation Temperature Unit

123

NRU

CSC-50b

CSC-50-blank

WAVELGTH

Spectrophotometer WAVELENGTH IN NANOMETERS

540

123

NRU

CSC-50b

CSC-50-blank

HUMID

Atmospheric Relative Humidity Percent

123

NRU

CSC-50b

CSC-50-blank

ATMCO2

Atmospheric CO2 Percent

123

NRU

CSC-50b

CSC-50-blank

SPTOBID

Sponsor defined tobacco identifier

CIG01a

123

NRU

CSC-50b

CSC-50-blank

EXPTYP

Exposure Type

Air Liquid Interface

123

NRU

CSC-50b

CSC-50-blank

SAMTYP

Sample Type

Whole Smoke Conditioned Media

123

NRU

CSC-50b

CSC-50-blank

INTRVN

Name of the Intervention Article

Tobacco ProdA

123

NRU

CSC-50b

CSC-50-blank

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

type of intervention article

PRODUCT

123

NRU

CSC-50b

CSC-50-blank

ITVCONC

intervention concentration

123

CSC-50b

CSC-50-blank

ITVCONCUintervention unitug/ml

IVTDMIN	In vitro Treatment Duration Minimum	47.5
14

123

NRU

CSC-50b

CSC-50-blank

STRAINStrain/SubstrainNO STRAIN

IVTDTRG	In vitro Treatment Duration Target	48
15

123

NRU

CSC-50b

CSC-50-blank

SPDEVIDSponsor defined device identifierPUFFMASTER3k

IVTDMAX	In vitro Treatment Duration Maximum	48.5
16

123

NRU

CSC-50b

CSC-50-blank

DUREFIDSmoking RegimeMedium Intensity Regimen

IVTDU	In vitro Treatment Duration Unit	HOURS
17	123

20123NRU

CSC-50b

CSC-50-blank

SPTOBID

Sponsor defined tobacco identifier

CIG01a

INCBTMP	Incubation Temperature	37
18

123

NRU

CSC-

50b	CSC-50-blank

TRTDMINTreatment Duration Minimum47.5

INCBTMPU	Incubation Temperature Unit	C
19	123

2123NRU

CSC-

50b	CSC-50-blank

TRTDTRGTreatment Duration Target483123

SWAVENM	Spectrophotometer Wavelength	540
20	123

NRU

CSC-

50b	CSC-50-blank

TRTDMAXTreatment Duration Maximum48.5

ATMRHP	Atmospheric Relative Humidity Percent	90
21

123

NRU

CSC-

50b	CSC-50-blank

TRTDUTreatment Duration UnitHOURS

ATMCO2P	Atmospheric CO2 Percent	5
22

123

NRU

CSC-

50b	CSC-50-blank

INCBTMPIncubation Temperature376123

SPDEVID	applicant defined device identifier	PUFFMASTER3k
23	123

NRU

CSC-

50b	CSC-50-blank

INCBTMPUIncubation Temperature UnitC

SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
24

123

NRU

CSC-

50b	CSC-50-blank

WAVELGTHSpectrophotometer WAVELENGTH IN NANOMETERS540

SPTOBID	Applicant-defined tobacco identifier	CIG01a
25

123

NRU

CSC-

50b	CSC-50-blank

HUMIDAtmospheric Relative Humidity Percent90

EXPTYP	Exposure Type	Air Liquid Interface
26	123

9123NRU

CSC-

50b	CSC-50-blank

ATMCO2Atmospheric CO2 Percent5

SAMTYP	Sample Type	Whole Smoke Conditioned Media
27

123

NRU

CSC-

50b	CSC-50-blank

SPTOBID

Sponsor defined tobacco identifier

CIG01a

ITVNAM	Name of the Intervention Article	Tobacco ProdA
28

123

NRU

CSC-

50b	CSC-50-blank

EXPTYP

ITVTYPE

Exposure

Intervention Article Type

Air Liquid Interface

PRODUCT

123

NRU

CSC-

50b	CSC-50-blank

SAMTYPSample TypeWhole Smoke Conditioned Media

ITVCONC	Intervention Article Concentration	50
30

123

NRU

CSC-

50b	CSC-50-blank

INTRVN

ITVCONCU

Name of the

Intervention Article

Tobacco ProdA

Concentration Unit	ug/ml
31

123

NRU

CSC-

5015123NRU

50b	CSC-50-blank

14ITVTYPE

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

type of intervention articlePRODUCT

31	CELLLN	Cell Line	NOT APPLICABLE
32	123

CSC-50

ITVCONCintervention concentration50

IVTDMIN	In vitro Treatment Duration Minimum	47.5
33

123

NRU

CSC-50

ITVCONCUintervention unitug/ml

IVTDTRG	In vitro Treatment Duration Target	48
34

123

NRU

CSC-50

STRAINStrain/SubstrainCHO18123

IVTDMAX	In vitro Treatment Duration Maximum	48.5
35	123

NRU

CSC-50

SPDEVIDSponsor defined device identifierPUFFMASTER3k

IVTDU	In vitro Treatment Duration Unit	HOURS
36	123

19123NRU

CSC-50

DUREFID

INCBTMP

Smoking RegimeMedium Intensity Regimen

Incubation Temperature	37
37

123

NRU

CSC-50

SPTOBID

Sponsor defined tobacco identifier

CIG01a

INCBTMPU	Incubation Temperature Unit	C
38

123

NRU

SLS

CSC-

110

SLS

CSC-

110

TRTDMINTreatment Duration Minimum47.5

SWAVENM	Spectrophotometer Wavelength	540
39

123

NRU

SLS

CSC-

110

SLS

CSC-

110

TRTDTRGTreatment Duration Target4823123

ATMRHP	Atmospheric Relative Humidity Percent	90
40	123

NRU

SLS

CSC-

110

SLS

CSC-

110

348.

TRTDMAXTreatment Duration Maximum

ATMCO2P

Atmospheric CO2 Percent

123

NRU

SLS

CSC-

110

SLS

CSC-

110

TRTDUTreatment Duration UnitHOURS

SPDEVID	applicant defined device identifier	PUFFMASTER3k
42

123

NRU

SLS

CSC-

110

SLS

CSC-

110

INCBTMP

SMKRGM

Incubation Temperature37

Smoking Regimen	MEDIUM INTENSITY REGIMEN
43

123

NRU

SLS

CSC-

110

SLS

CSC-

110

INCBTMPUIncubation Temperature UnitC
27123

SPTOBID	Applicant-defined tobacco identifier	CIG01a
44	123

NRU

SLS

CSC-

110

SLS

CSC-

110

WAVELGTHSpectrophotometer WAVELENGTH IN NANOMETERS540

EXPTYP	Exposure Type	Air Liquid Interface
45

123

NRU

SLS

CSC-

110

SLS

CSC-

110

HUMIDAtmospheric Relative Humidity Percent90

SAMTYP	Sample Type	Whole Smoke Conditioned Media
46

123

NRU

SLS

CSC-

110

SLS

CSC-

110

ATMCO2Atmospheric CO2 Percent5

ITVNAM	Intervention Article Name	Tobacco ProdA
47

123

NRU

SLS

CSC-

110

SLS

CSC-

110

SPTOBID

Sponsor defined tobacco identifier

CIG01a

ITVTYPE	Intervention Article Type	PRODUCT
48	123

31123NRU

SLS

CSC-

110

SLS

CSC-

110

EXPTYP

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	refid.xpt

Image Removed

relref.xpt

Row

STUDYID

ASSAYID

SETCD

REFTYPE

REFID

PARENT

LEVEL

1123NRUALLASSAY123NRU12123NRU

CSC-50b

SET1-3b123NRU23123NRU

CSC-50b

Experimental Unit1-3-A1-3b35123NRU

CSC-50b

Experimental Unit1-3-H1-3b36123NRUCSC-50SET1-3123NRU27123NRUCSC-50Experimental Unit1-3-B1-338123NRUCSC-50Experimental Unit1-3-C1-339123NRUSLS-1101-10123NRU210123NRUSLS-1102-10123NRU211123NRUSLS-1101-10-G1-10312123NRUSLS-1102-10-G2-103

ITVCONC	Intervention Article Concentration	50
49	123	TX	CSC-50	CSC-50	49	ITVCONCU	Intervention Article Concentration Unit	ug/ml
50	123	TX	CSC-50	CSC-50	50	CELLLN	Cell Line	NHK
51	123	TX	SLS-110	SLS-110	51	IVTDMIN	In vitro Treatment Duration Minimum	47.5
52	123	TX	SLS-110	SLS-110	52	IVTDTRG	In vitro Treatment Duration Target	48
53	123	TX	SLS-110	SLS-110	53	IVTDMAX	In vitro Treatment Duration Maximum	48.5
54	123	TX	SLS-110	SLS-110	54	IVTDU	In vitro Treatment Duration Unit	HOURS
55	123	TX	SLS-110	SLS-110	55	INCBTMP	Incubation Temperature	37
56	123	TX	SLS-110	SLS-110	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 defined device identifier	PUFFMASTER3k
61	123	TX	SLS-110	SLS-110	61	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
62	123	TX	SLS-110	SLS-110	62	SPTOBID	Applicant-defined tobacco identifier	CIG01a
63	123	TX	SLS-110	SLS-110	63	EXPTYP	Exposure Type	Air Liquid Interface
64	123	TX	SLS-110	SLS-110	64	SAMTYP	Sample Type	Liquid
65	123	TX	SLS-110	SLS-110	65	ITVNAM	Intervention Article Name	Sodium Laurel Sulfate
66	123	TX	SLS-110	SLS-110	66	ITVTYPE	Intervention Article Type	POSITIVE CONTROL
67	123	TX	SLS-110	SLS-110	67	ITVCONC	Intervention Article Concentration	110
68	123	TX	SLS-110	SLS-110	68	ITVCONCU	Intervention Article Concentration Unit	ug/ml
69	123	TX	SLS-110	SLS-110	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

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

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

1-3-B

RELABS

Relative Absorbance Reading

77.7


4	123

NRU

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

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


12	123

NRU

1-10-G

RELABS

Relative Absorbance Reading

8.57

578.57

57	8.57
13	123	GT	13

1-10

RELABS

Relative Absorbance Reading

8.94

MEAN

8.94


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

...


15	123	GT	15

1-10

RELABS

Relative Absorbance Reading

30.5

COEFFICIENT OF VARIANCE

30.5


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


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

160


18	123

NRU

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

NRU

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

NRU

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

NRU

2-10

RELABS

Relative Absorbance Reading

14.1

COEFFICIENT OF VARIANCE

14.1

161


22	123

NRU

123NRU

EC50

EC50CYTX

Effective Concentration of 50 Percent Cytotoxicity

123

ug/ml

123

ug/ml

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Versions Compared

Old Version 55

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)