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This example shows a report table, trial design, TOBA-78 - Getting issue details... STATUS and results data for the in vitro neutral red uptake (NRU) cytotoxicity assay TOBA-333 - Getting issue details... STATUS in example study 123.

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 TOBA-593 - Getting issue details... STATUS 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.

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

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 TOBA-356 - Jira project doesn't exist or you don't have permission to view it. 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). TOBA-56 - Jira project doesn't exist or you don't have permission to view it.

ts.xpt

xx.xpt

Row

STUDYID

GNTXAID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123NRUTS1
GLPTYPGood Laboratory Practice TypeFDA
2123NRUTS2
GLPTYPGood Laboratory Practice TypeOECD
3123NRUTS1
STSTDTCStudy Start Date2022-05-25
4123NRUTS1
STITLEStudy Title

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


5123NRUTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123NRUTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123NRUTS1
APPLCNTApplicant OrganizationExample Applicant Inc.
8123NRUTS1
APREFIDApplicant Study Reference ID
NOT APPLICABLE
9123NRUTS11TSTFNAMTest Facility NameExample Test Lab Name
10123NRUTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123NRUTS11TFCNTRYTest Facility CountryUSA
12123NRUTS11STDIRStudy DirectorDr. R. Smith
13123NRUTS1
GLPFLGLP FlagY
14123NRUTS14TSTGDNAMTesting Guideline NamePublication No. 07-4519
15123NRUTS14TSTGDORGTesting Guideline OrganizationNIH
16123NRUTS14TSTGDVERTesting Guideline Version2006-11
17123NRUTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
18123NRUTS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake
19123NRUTS1
SPECIESSpeciesHUMAN
20123NRUTS1
CELLLNCell LineNHK
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

TOBA-279 - Getting issue details... STATUS

Rows 1-12:Show the test conditions for the set with a short name or SETCD value of ALL. The applicant chose this value to represent test conditions for the entire assay.
Rows 13-20: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 50 µg/mL of cigarette smoke condensate as shown in the report table for study 123.
Row 20:Shows the value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells.
Rows 21-28: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 50 µg/mL of cigarette smoke condensate as shown in the report table for study 123.
Rows 29-36: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 110 µg/mL of sodium laurel sulfate as shown in the report table for study 123.

tx.xpt

xx.xpt

RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123NRUTXALLALL_ASSAY1IVTDMINIn vitro Treatment Duration Minimum47.5
2123NRUTXALLALL_ASSAY

2

IVTDTRGIn vitro Treatment Duration Target48
3123NRUTXALLALL_ASSAY3IVTDMAXIn vitro Treatment Duration Maximum48.5
4123NRUTXALLALL_ASSAY4IVTDUIn vitro Treatment Duration UnitHOURS
5123NRUTXALLALL_ASSAY5INCBTMPIncubation Temperature37
6123NRUTXALLALL_ASSAY6INCBTMPUIncubation Temperature UnitC
7123NRUTXALLALL_ASSAY7SWAVENMSpectrophotometer Wavelength540
8123NRUTXALLALL_ASSAY8ATMRHPAtmospheric Relative Humidity Percent90
9123NRUTXALLALL_ASSAY9ATMCO2PAtmospheric CO2 Percent5
10123NRUTXALLALL_ASSAY10SPDEVIDapplicant defined device identifierPUFFMASTER3k
11123NRUTXALLALL_ASSAY11SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
12123NRUTXALLALL_ASSAY12SPTOBID

Applicant-defined tobacco identifier

CIG01a
13123NRUTXCSC-50bCSC-50-blank13PSETCD

Parent Set Code

ALL
14123NRUTXCSC-50bCSC-50-blank14EXPTYP

Exposure Type

Air Liquid Interface
15123NRUTXCSC-50bCSC-50-blank15SAMTYPSample TypeWhole Smoke Conditioned Media
16123NRUTXCSC-50bCSC-50-blank16ITVNAMName of the Intervention ArticleTobacco ProdA
17123NRUTXCSC-50bCSC-50-blank17ITVTYPEIntervention Article TypePRODUCT
18123NRUTXCSC-50bCSC-50-blank18ITVCONC

Intervention Article Concentration

50
19123NRUTXCSC-50bCSC-50-blank19ITVCONCUIntervention Article Concentration Unitug/ml
20123NRUTXCSC-50bCSC-50-blank20CELLLNCell LineNOT APPLICABLE
21123NRUTXCSC-50CSC-5021PSETCD

Parent Set Code

ALL
22123NRUTXCSC-50CSC-5022EXPTYP

Exposure Type

Air Liquid Interface
23123NRUTXCSC-50CSC-5023SAMTYPSample TypeWhole Smoke Conditioned Media
24123NRUTXCSC-50CSC-5024ITVNAMIntervention Article NameTobacco ProdA
25123NRUTXCSC-50CSC-5025ITVTYPEIntervention Article TypePRODUCT
26123NRUTXCSC-50CSC-5026ITVCONC

Intervention Article Concentration

50
27123NRUTXCSC-50CSC-5027ITVCONCUIntervention Article Concentration Unitug/ml
28123NRUTXCSC-50CSC-5028CELLLNCell LineNHK
29123NRUTXSLS-110SLS-11029PSETCD

Parent Set Code

ALL
30123NRUTXSLS-110SLS-11030EXPTYP

Exposure Type

Air Liquid Interface
31123NRUTXSLS-110SLS-11031SAMTYPSample TypeLiquid
32123NRUTXSLS-110SLS-11032ITVNAMIntervention Article NameSodium Laurel Sulfate
33123NRUTXSLS-110SLS-11033ITVTYPEIntervention Article TypePOSITIVE CONTROL
34123NRUTXSLS-110SLS-11034ITVCONC

Intervention Article Concentration

110
35123NRUTXSLS-110SLS-11035ITVCONCUIntervention Article Concentration Unitug/ml
36123NRUTXSLS-110SLS-11036CELLLNCell LineNHK
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

TOBA-280 - Getting issue details... STATUS

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 - 12), 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.
$titleHtml

relref.xpt

Row

STUDYID

GNTXAID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1123NRUALL123NRU
1ASSAY
2123NRU

CSC-50b

1-3b123NRU2TRIAL SET
3123NRU

CSC-50b

1-3-A1-3b3EXPERIMENTAL UNIT
4123NRU

CSC-50b

1-3-H1-3b3EXPERIMENTAL UNIT
5123NRUCSC-501-3123NRU2TRIAL SET
6123NRUCSC-501-3-B1-33EXPERIMENTAL UNIT
7123NRUCSC-501-3-C1-33EXPERIMENTAL UNIT
8123NRUSLS-1101-10123NRU2TRIAL SET
9123NRUSLS-1102-10123NRU2TRIAL SET
10123NRUSLS-1101-10-G1-103EXPERIMENTAL UNIT
11123NRUSLS-1102-10-G2-103EXPERIMENTAL UNIT
$warningHtml

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TOBA-592 - Getting issue details... STATUS

gt.xpt

gt.xpt

RowSTUDYIDGNTXAIDDOMAINGTSEQGTREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRTGTSTRESCGTSTRESNGTSTRESU
1123NRUGT11-3-BABSORBAbsorbance Reading1.7

1.71.7
2123NRUGT21-3-BBKCABSBackground Corrected Absorbance Reading

1.6



1.61.6
3123NRUGT31-3-BRELABSRelative Absorbance Reading77.7%
77.777.7%
4123NRUGT41-3-CABSORBAbsorbance Reading1.8

1.81.8
5123NRUGT51-3-CBKCABSBackground Corrected Absorbance Reading

1.7



1.71.7
6123NRUGT61-3-CRELABSRelative Absorbance Reading77.4

77.477.4
7123NRUGT71-3RELABSRelative Absorbance Reading78.2%MEAN78.278.2%
8123NRUGT81-3RELABSRelative Absorbance Reading2.9%STANDARD DEVIATION2.92.9%
9123NRUGT91-3RELABSRelative Absorbance Reading3.6
COEFFICIENT OF VARIANCE3.63.6
10123NRUGT101-10-GABSORBAbsorbance Reading0.7

0.70.7
11123NRUGT111-10-GBKCABSBackground Corrected Absorbance Reading

0.6



0.6

0.6


12123NRUGT121-10-GRELABSRelative Absorbance Reading8.57

8.578.57
13123NRUGT131-10RELABSRelative Absorbance Reading

8.94

%MEAN

8.94

8.94


14123NRUGT141-10RELABSRelative Absorbance Reading

2.72

%

STANDARD DEVIATION

2.72

2.72


15123NRUGT151-10RELABSRelative Absorbance Reading

30.5


COEFFICIENT OF VARIANCE

30.5

30.5


16123NRUGT162-10-GABSORBAbsorbance Reading0.9




17123NRUGT172-10-GBKCABSBackground Corrected Absorbance Reading

0.8






18123NRUGT182-10-GRELABSRelative Absorbance Reading6.30

6.306.30
19123NRUGT192-10RELABSRelative Absorbance Reading

5.91

%MEAN

5.91

5.91


20123NRUGT202-10RELABSRelative Absorbance Reading

0.83

%

STANDARD DEVIATION

0.83

0.83


21123NRUGT212-10RELABSRelative Absorbance Reading

14.1


COEFFICIENT OF VARIANCE

14.1

14.1


22123NRUGT22123NRU

EC50CYTX TOBA-132 - Jira project doesn't exist or you don't have permission to view it.

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

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