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titleSample 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

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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:

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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).  

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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

1123TS1
GLPTYPGood Laboratory Practice TypeFDA
2123TS2
GLPTYPGood Laboratory Practice TypeOECD
3123TS1
GLPFLGLP FlagY
4123TS1
STSTDTCStudy Start Date2022-05-25
5123TS1
STITLEStudy Title

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


6123TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7123TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
8123TS1
APPLCNTApplicant OrganizationExample Applicant Inc.
9123TS1
APREFIDApplicant Study Reference ID
NOT APPLICABLE
10123TS11TSTFNAMTest Facility NameExample Test Lab Name
11123TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
12123TS11TFCNTRYTest Facility CountryUSA
13123TS11STDIRStudy DirectorDr. R. Smith
14123TS14TSTGDNAMTesting Guideline NamePublication No. 07-4519
15123TS14TSTGDORGTesting Guideline OrganizationNIH
16123TS14TSTGDVERTesting Guideline Version2006-11
17123TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
18123TS1
GNTXAIDGenetic Toxicology Assay IdentifierNRU
19123TS1
SPECIESSpeciesHUMAN
20123TS1
CELLLNCell LineNHK

...

Dataset wrap
Namerelref

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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) which have LVLDESC of OBSERVATIONAL UNIT.  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 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 - 12), and row (A-G) of the 96-well plates.
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
tableidrelref

Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1123NRU123NRU
1ASSAY
2123

CSC-50b

1-3b123NRU2OBSERVATIONAL UNIT
3123

CSC-50b

1-3-A1-3b3EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
4123

CSC-50b

1-3-H1-3b3EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
5123CSC-501-3123NRU2OBSERVATIONAL UNIT
6123CSC-501-3-B1-33EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
7123CSC-501-3-C1-33EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
8123SLS-1101-10123NRU2OBSERVATIONAL UNIT
9123SLS-1102-10123NRU2OBSERVATIONAL UNIT
10123SLS-1101-10-G1-103EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
11123SLS-1102-10-G2-103EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
Dataset wrap
Namegt
Rowcaps
Rows 1-3:Show the experimental unit data for GTREFID 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 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.

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Dataset2
RowSTUDYIDDOMAINGTSEQGTREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRTGTSTRESCGTSTRESNGTSTRESU
1123GT11-3-BABSORBAbsorbance Reading1.7

1.71.7
2123GT21-3-BBKCABSBackground Corrected Absorbance Reading

1.6



1.61.6
3123GT31-3-BRELABSRelative Absorbance Reading77.7%
77.777.7%
4123GT41-3-CABSORBAbsorbance Reading1.8

1.81.8
5123GT51-3-CBKCABSBackground Corrected Absorbance Reading

1.7



1.71.7
6123GT61-3-CRELABSRelative Absorbance Reading77.4

77.477.4
7123GT71-3RELABSRelative Absorbance Reading78.2%MEAN78.278.2%
8123GT81-3RELABSRelative Absorbance Reading2.9%STANDARD DEVIATION2.92.9%
9123GT91-3RELABSRelative Absorbance Reading3.6
COEFFICIENT OF VARIANCE3.63.6
10123GT101-10-GABSORBAbsorbance Reading0.7

0.70.7

11

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123GT111-10-GBKCABSBackground Corrected Absorbance Reading

0.6



0.6

0.6


12123GT121-10-GRELABSRelative Absorbance Reading8.57

8.578.57
13123GT131-10RELABSRelative Absorbance Reading

8.94

%MEAN

8.94

8.94


14123GT141-10RELABSRelative Absorbance Reading

2.72

%

STANDARD DEVIATION

2.72

2.72


15123GT151-10RELABSRelative Absorbance Reading

30.5


COEFFICIENT OF VARIANCE

30.5

30.5


16123GT162-10-GABSORBAbsorbance Reading0.9




17123GT172-10-GBKCABSBackground Corrected Absorbance Reading

0.8






18123GT182-10-GRELABSRelative Absorbance Reading6.30

6.306.30
19123GT192-10RELABSRelative Absorbance Reading

5.91

%MEAN

5.91

5.91


20123GT202-10RELABSRelative Absorbance Reading

0.83

%

STANDARD DEVIATION

0.83

0.83


21123GT212-10RELABSRelative Absorbance Reading

14.1


COEFFICIENT OF VARIANCE

14.1

14.1


22123GT22123NRU

EC50CYTX

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Effective Concentration of 50 Percent Cytotoxicity123ug/ml
123123ug/ml

...