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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.  

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

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

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

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

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


5123TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123TS1
APPLCNTApplicant OrganizationExample Applicant Inc.
8123TS1
APREFIDApplicant Study Reference ID
NOT APPLICABLE
9123TS11TSTFNAMTest Facility NameExample Test Lab Name
10123TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123TS11TFCNTRYTest Facility CountryUSA
12123TS11STDIRStudy DirectorDr. R. Smith
13123TS1
GLPFLGLP FlagY
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
$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 NRU. 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

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123TXNRUNRU_ASSAY1IVTDMINIn vitro Treatment Duration Minimum47.5
2123TXNRUNRU_ASSAY

2

IVTDTRGIn vitro Treatment Duration Target48
3123TXNRUNRU_ASSAY3IVTDMAXIn vitro Treatment Duration Maximum48.5
4123TXNRUNRU_ASSAY4IVTDUIn vitro Treatment Duration UnitHOURS
5123TXNRUNRU_ASSAY5INCBTMPIncubation Temperature37
6123TXNRUNRU_ASSAY6INCBTMPUIncubation Temperature UnitC
7123TXNRUNRU_ASSAY7SWAVENMSpectrophotometer Wavelength540
8123TXNRUNRU_ASSAY8ATMRHPAtmospheric Relative Humidity Percent90
9123TXNRUNRU_ASSAY9ATMCO2PAtmospheric CO2 Percent5
10123TXNRUNRU_ASSAY10SPDEVIDapplicant defined device identifierPUFFMASTER3k
11123TXNRUNRU_ASSAY11SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
12123TXNRUNRU_ASSAY12SPTOBID

Applicant-defined tobacco identifier

CIG01a
13123TXCSC-50bCSC-50-blank13PSETCD

Parent Set Code

NRU
14123TXCSC-50bCSC-50-blank14EXPTYP

Exposure Type

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

Intervention Article Concentration

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

Parent Set Code

NRU
22123TXCSC-50CSC-5022EXPTYP

Exposure Type

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

Intervention Article Concentration

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

Parent Set Code

NRU
30123TXSLS-110SLS-11030EXPTYP

Exposure Type

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

Intervention Article Concentration

110
35123TXSLS-110SLS-11035ITVCONCUIntervention Article Concentration Unitug/ml
36123TXSLS-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) 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.
$titleHtml

relref.xpt

Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1123NRU123NRU
1ASSAY
2123

CSC-50b

1-3b123NRU2OBSERVATIONAL UNIT
3123

CSC-50b

1-3-A1-3b3EXPERIMENTAL UNIT
4123

CSC-50b

1-3-H1-3b3EXPERIMENTAL UNIT
5123CSC-501-3123NRU2OBSERVATIONAL UNIT
6123CSC-501-3-B1-33EXPERIMENTAL UNIT
7123CSC-501-3-C1-33EXPERIMENTAL UNIT
8123SLS-1101-10123NRU2OBSERVATIONAL UNIT
9123SLS-1102-10123NRU2OBSERVATIONAL UNIT
10123SLS-1101-10-G1-103EXPERIMENTAL UNIT
11123SLS-1102-10-G2-103EXPERIMENTAL UNIT
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

TOBA-592 - Getting issue details... STATUS

gt.xpt

gt.xpt

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
11123GT111-10-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 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

Dataset Debug Messages

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