Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

This example shows a report table, trial design,

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-78
and results data for the in vitro neutral red uptake (NRU) cytotoxicity assay
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-333
in example study 123.

Expand
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

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-593
value for the entire assay. The grey cells in plate 1 are cells 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

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data

)




Sample ID

Smoke Regime

Replicate Number

Plate Number

Well Number



Relative Assay Plate Absorbance Readings





Cigarette Smoke Condensate (µg/mL) 

SLS (µg/mL)


EC50 (µg/ml)

0

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

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

2

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

3

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

4

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

5

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

6

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

7

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

8

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

1

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

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

3

C


107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780




030001

Medium

1

2

4

D


104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780




030001

Medium

1

2

5

E


101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02




030001

Medium

1

2

6

F


110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540




030001

Medium

1

2

7

G


104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780




030001

Medium

1

2

8

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
Show that TSGRPID has been used  
Rowcaps
8 the applicant's
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
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-356
study reference ID is not applicable.
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
Rows 9-12:
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).

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-56

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

GNTXAID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123
NRU
TS1
GLPTYPGood Laboratory Practice TypeFDA
2123
NRU
TS2
GLPTYPGood Laboratory Practice TypeOECD
3123
TS1
GLPFLGLP FlagY
4123
NRU
TS1
STSTDTCStudy Start Date2022-05-25
4

5123
NRU
TS1
STITLEStudy Title

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

5

6123
NRU
TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6

7123
NRU
TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7

8123
NRU
TS1
APPLCNTApplicant
Organization
Example Applicant Inc.
8

9123
NRU
TS1
APREFIDApplicant Study Reference ID
NOT APPLICABLE
9
10123
NRU
TS11TSTFNAMTest Facility NameExample Test Lab Name
10

11123
NRU
TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11

12123
NRU
TS11TFCNTRYTest Facility CountryUSA
12

13123
NRU
TS11STDIRStudy DirectorDr. R. Smith
13123NRUTS1GLPFLGLP FlagY

14123
NRU
TS14TSTGDNAMTesting Guideline NamePublication No. 07-4519
15123
NRU
TS14TSTGDORGTesting Guideline OrganizationNIH
16123
NRU
TS14TSTGDVERTesting Guideline Version2006-11
17123
NRU
TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
18123
NRU
TS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake

GNTXAIDGenetic Toxicology Assay IdentifierNRU
19123
NRU
TS1
SPECIESSpecies
Human
HUMAN
20123
NRU
TS1
CELLLNCell LineNHK
jira
Dataset wrap
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-279
Rowcaps
Rows 1-12:Show the test conditions for the set with a short name or SETCD value of ALLNRU. The applicant chose this value to represent test conditions for the entire assay. 
Rows 13-2031: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 number 1row A, well column 3, with a concentration of 50µg/mLof cigarette smoke condensate as shown in the report table for study 123.Row 20:Shows the   The value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells. 

Rows 2132-2850:

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, with a 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 2951-3669:Show the test conditions for the set with a short name or SETCD value of SLS-110. The applicant chose this value to represent both wells numbered 7 in plate number 1, well rows B-G, well column 10, and plate number 2, with a 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
ROWSTUDYID
GNTXAID
DOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY1IVTDMINIn vitro Treatment Duration Minimum47.5
2123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY2IVTDTRGIn vitro Treatment Duration Target48
3123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY3IVTDMAXIn vitro Treatment Duration Maximum48.5
4123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY4IVTDUIn vitro Treatment Duration UnitHOURS
5123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY5INCBTMPIncubation Temperature37
6123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY6INCBTMPUIncubation Temperature UnitC
7123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY7SWAVENMSpectrophotometer Wavelength540
8123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY8ATMRHPAtmospheric Relative Humidity Percent90
9123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY9ATMCO2PAtmospheric CO2 Percent5
10123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY10SPDEVIDapplicant defined device identifierPUFFMASTER3k
11123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY11SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
12123
NRU
TX
ALL
NRU
ALL
NRU_ASSAY12SPTOBID

Applicant-defined tobacco identifier

CIG01a
13123
NRU
TXCSC-50bCSC-50-blank13
PSETCD

Parent Set Code

IVTDMINIn vitro Treatment Duration Minimum47.5
ALL
14123
NRU
TX
TX
CSC-50bCSC-50-blank14
EXPTYP

Exposure Type

IVTDTRGIn vitro Treatment Duration Target48
Air Liquid Interface
15123
NRU
TXCSC-50bCSC-50-blank15
SAMTYPSample Type
IVTDMAXIn vitro Treatment Duration Maximum48.5
Whole Smoke Conditioned Media
16123
NRU
TXCSC-50bCSC-50-blank16
ITVNAMName of the Intervention Article
IVTDUIn vitro Treatment Duration UnitHOURS
Tobacco ProdA
17123
NRU
TXCSC-50bCSC-50-blank17
ITVTYPEIntervention Article Type
INCBTMPIncubation Temperature37
PRODUCT
18123
NRU
TXCSC-50bCSC-50-blank18
ITVCONC

Intervention Article Concentration

INCBTMPUIncubation Temperature UnitC
50
19123
NRU
TXCSC-50bCSC-50-blank19
ITVCONCUIntervention Article Concentration Unit
SWAVENMSpectrophotometer Wavelength540
ug/ml
20123
NRU
TXCSC-50bCSC-50-blank20
CELLLNCell Line
ATMRHPAtmospheric Relative Humidity Percent90
NOT APPLICABLE
21123
NRU
TXCSC-
50
50bCSC-50-blank21
PSETCD

Parent Set Code

ATMCO2PAtmospheric CO2 Percent5
ALL
22123
NRU
TXCSC-
50
50bCSC-50-blank22
EXPTYP

Exposure Type

SPDEVIDapplicant defined device identifierPUFFMASTER3k
Air Liquid Interface
23123
NRU
TXCSC-
50
50bCSC-50-blank23
SAMTYP
SMKRGM
Sample Type
Smoking RegimenMEDIUM INTENSITY REGIMEN
Whole Smoke Conditioned Media
24123
NRU
TXCSC-
50
50bCSC-50-blank24
ITVNAMIntervention Article Name
SPTOBID

Applicant-defined tobacco identifier

CIG01a
Tobacco ProdA
25123
NRU
TXCSC-
50
50bCSC-50-blank25
ITVTYPE
EXPTYP
Intervention Article

Exposure Type

PRODUCT
Air Liquid Interface
26123
NRU
TXCSC-
50
50bCSC-50-blank26
ITVCONC

Intervention Article Concentration

SAMTYPSample TypeWhole Smoke Conditioned Media
50
27123
NRU
TXCSC-
50
50bCSC-50-blank27
ITVCONCU
ITVNAMName of the Intervention Article
Concentration Unitug/ml
Tobacco ProdA
28123
NRU
TXCSC-
50
50bCSC-50-blank28
CELLLNCell Line
ITVTYPEIntervention Article TypePRODUCT
NHK
29123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank29
PSETCD

Parent Set Code

ITVCONC

Intervention Article Concentration

50
ALL
30123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank30
EXPTYP

Exposure Type

ITVCONCUIntervention Article Concentration Unitug/ml
Air Liquid Interface
31123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank31
SAMTYP
CELLLN
Sample Type
Cell LineNOT APPLICABLE
Liquid
32123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
5032
ITVNAMIntervention Article Name
IVTDMINIn vitro Treatment Duration Minimum47.5
Sodium Laurel Sulfate
33123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
5033
ITVTYPEIntervention Article Type
IVTDTRGIn vitro Treatment Duration Target48
POSITIVE CONTROL
34123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
5034
ITVCONC

Intervention Article Concentration

IVTDMAXIn vitro Treatment Duration Maximum48.5
110
35123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
5035
ITVCONCUIntervention Article Concentration Unit
IVTDUIn vitro Treatment Duration UnitHOURS
ug/ml
36123
NRU
TX
SLS
CSC-
110
50
SLS
CSC-
110
5036
CELLLN
INCBTMP
Cell Line
Incubation Temperature
NHK
37