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This example shows a report table, trial design

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, and results data for the in vitro Neutral Red Uptake Cytotoxicity Assay neutral red uptake (NRU) cytotoxicity assay 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.g. Average, Standard Deviation, Coeff. Var., average, standard deviation, coefficient variation) for each plate and an EC50 value for the entire assay. The grey cells in In the table below, the light grey shading for plate 1 are cells values from wells that do not contain the CHO Hamster cells. 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)

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).

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

 













123

Dataset wrap
Rowcaps
two Types 8 the sponsor's study reference ID is not applicable 912 Study Director Test Facility
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.
NRU
Dataset2
Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123
Dataset2

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123
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
SSPONSOR

APPLCNT
Sponsor Organization
ApplicantExample
Sponsor
Applicant Inc.
8

9123
NRU
TS1
SPREFID

APREFID
Sponsor
Applicant 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
13

14123
NRU
TS1
GLPFL
4
GLP FlagY14123NRUTS1ASTDAssay StandardNIH
TSTGDNAMTesting Guideline Name
Publication No. 07-4519
15123
NRU
TS1
ASTDVAssay Standard Version
4TSTGDORGTesting Guideline OrganizationNIH
2006-11

16123
NRU
TS14TSTGDVERTesting Guideline Version2006-11
17123TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17

18123
NRU
TS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake

GNTXAIDGenetic Toxicology Assay IdentifierNRU
19123
18123NRU
TS1
SPECIESSpecies
Hamster
HUMAN
19

20123
NRU
TS1
TESTSYS

CELLLN
Test System
Cell Line
CHO
NHK
Dataset wrap
Shows the value for STRAIN/SUBSTRAIN is NO STRAIN because the well is a media only well, having no CHO Hamster cells
Rowcaps
Rows 1-
20
12:Show the test conditions for the set with a short name or SETCD value of
CSC-50b
NRU.
 
The
sponsor
applicant chose this value to represent
plate number 1, well number 1, with a concentration of 50µg/mLof Cigarette Smoke Condensate as shown in the report table for study 123.
Row 17:
test conditions for the entire assay
Rows
21
13-
40
31:Show the test conditions for the set with a short name or SETCD value of CSC-
50
50b.
 
The
sponsor
applicant chose this value to represent plate number 1, well
number 2
row A, well column 3, with a concentration of 50µg/mLof
Cigarette Smoke Condensate
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

41

32-

60

50:

Show the test conditions for the set with a short name or SETCD value of CSC-50.
 
The
sponsor
applicant chose this value to represent
both wells numbered 7 in
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
110
50µg/mLof
Sodium Laurel Sulfate as shown in the report table for study 123
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.
NRU
Dataset2
ROWSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123TXNRUNRU_ASSAY1IVTDMINIn vitro Treatment Duration Minimum47.5
2123TXNRUNRU_ASSAY2IVTDTRGIn 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
13123
Dataset2
RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123
TXCSC-50bCSC-50-blank
1
13
TRTDMIN
IVTDMINIn vitro Treatment Duration Minimum47.5
2
14123
NRU
TXCSC-50bCSC-50-blank
2
14
TRTDTRG
IVTDTRGIn vitro Treatment Duration Target48
3
15123
NRU
TXCSC-50bCSC-50-blank
3
15
TRTDMAX
IVTDMAXIn vitro Treatment Duration Maximum48.5
4
16123
NRU
TXCSC-50bCSC-50-blank
4
16
TRTDU
IVTDUIn vitro Treatment Duration UnitHOURS
5
17123
NRU
TXCSC-50bCSC-50-blank
5
17INCBTMPIncubation Temperature37
6
18123
NRU
TXCSC-50bCSC-50-blank
6
18INCBTMPUIncubation Temperature UnitC
7
19123
NRU
TXCSC-50bCSC-50-blank
7
19
WAVELGTH
SWAVENMSpectrophotometer
wavelength in nanometers
Wavelength540
8
20123
NRU
TXCSC-50bCSC-50-blank
8
20
HUMID
ATMRHPAtmospheric Relative Humidity Percent90
9
21123
NRU
TXCSC-50bCSC-50-blank
9
21
ATMCO2
ATMCO2PAtmospheric CO2
Percent510123NRUTXCSC-50bCSC-50-blank10SPTOBID

Sponsor defined tobacco identifier

CIG01a11
Percent5
22123
NRU
TXCSC-50bCSC-50-blank
11
22
EXPTYP

Exposure Type

Air Liquid Interface12123
SPDEVIDapplicant defined device identifierPUFFMASTER3k
23123
NRU
TXCSC-50bCSC-50-blank
12
23
SAMTYP
SMKRGM
Sample TypeWhole Smoke Conditioned Media
Smoking RegimenMEDIUM INTENSITY REGIMEN
24
13
123
NRU
TXCSC-50bCSC-50-blank
13
24
INTRVNName of the Intervention ArticleTobacco ProdA
SPTOBID

Applicant-defined tobacco identifier

CIG01a
25123
14123NRU
TXCSC-50bCSC-50-blank
14
25
ITVTYPEtype of intervention articlePRODUCT
EXPTYP

Exposure Type

Air Liquid Interface
26
15
123
NRU
TXCSC-50bCSC-50-blank
15
26
ITVCONC
SAMTYP
intervention concentration50
Sample TypeWhole Smoke Conditioned Media
27123
16123NRU
TXCSC-50bCSC-50-blank
16
27
ITVCONCUintervention unitug/ml
ITVNAMName of the Intervention ArticleTobacco ProdA
28
17
123
NRU
TXCSC-50bCSC-50-blank
17
28
STRAINStrain/SubstrainNO STRAIN
ITVTYPEIntervention Article TypePRODUCT
29123
18123NRU
TXCSC-50bCSC-50-blank
18
29
SPDEVIDSponsor defined device identifierPUFFMASTER3k
ITVCONC

Intervention Article Concentration

50
30
19
123
NRU
TXCSC-50bCSC-50-blank
19
30
DUREFIDSmoking RegimeMedium Intensity Regimen
ITVCONCUIntervention Article Concentration Unitug/ml
31123
20123NRU
TXCSC-50bCSC-50-blank
20
31
SPTOBID

Sponsor defined tobacco identifier

CIG01a
CELLLNCell LineNOT APPLICABLE
32
21
123
NRU
TXCSC-50CSC-50
1
32
TRTDMIN
IVTDMINIn vitro Treatment Duration Minimum47.5
22
33123
NRU
TXCSC-50CSC-50
2
33
TRTDTRG
IVTDTRGIn vitro Treatment Duration Target48
23
34123
NRU
TXCSC-50CSC-50
3
34
TRTDMAX
IVTDMAXIn vitro Treatment Duration Maximum48.5
24
35123
NRU
TXCSC-50CSC-50
4
35
TRTDU
IVTDUIn vitro Treatment Duration UnitHOURS
25
36123
NRU
TXCSC-50CSC-50
5
36INCBTMPIncubation Temperature37
26
37123
NRU
TXCSC-50CSC-50
6
37INCBTMPUIncubation Temperature UnitC
27
38123
NRU
TXCSC-50CSC-50
7
38
WAVELGTH
SWAVENMSpectrophotometer
wavelength in nanometers
Wavelength540
28
39123
NRU
TXCSC-50CSC-50
8
39
HUMID
ATMRHPAtmospheric Relative Humidity Percent90
29
40123
NRU
TXCSC-50CSC-50
9
40
ATMCO2
ATMCO2PAtmospheric CO2 Percent
530123NRUTXCSC-50CSC-5010SPTOBID

Sponsor defined tobacco identifier

CIG01a31123
5
41123
NRU
TXCSC-50CSC-50
11
41
EXPTYP

Exposure Type

Air Liquid Interface
SPDEVIDapplicant defined device identifierPUFFMASTER3k
42
32
123
NRU
TXCSC-50CSC-50
12
42
SAMTYP
SMKRGM
Sample TypeWhole Smoke Conditioned Media
Smoking RegimenMEDIUM INTENSITY REGIMEN
43123
33123NRU
TXCSC-50CSC-50
13
43
INTRVNName of the Intervention ArticleTobacco ProdA34123
SPTOBID

Applicant-defined tobacco identifier

CIG01a
44123
NRU
TXCSC-50CSC-50
14
44
ITVTYPEtype of intervention articlePRODUCT
EXPTYP

Exposure Type

Air Liquid Interface
45
35
123
NRU
TXCSC-50CSC-50
15
45
ITVCONC
SAMTYP
intervention concentration50
Sample TypeWhole Smoke Conditioned Media
46
36
123
NRU
TXCSC-50CSC-50
16
46
ITVCONCUintervention unitug/ml37123
ITVNAMIntervention Article NameTobacco ProdA
47123
NRU
TXCSC-50CSC-50
17
47
STRAINStrain/SubstrainCHO
ITVTYPEIntervention Article TypePRODUCT
48
38
123
NRU
TXCSC-50CSC-50
18
48
SPDEVIDSponsor defined device identifierPUFFMASTER3k
ITVCONC

Intervention Article Concentration

50
49123
39123NRU
TXCSC-50CSC-50
19
49
DUREFIDSmoking RegimeMedium Intensity Regimen
ITVCONCUIntervention Article Concentration Unitug/ml
50
40
123
NRU
TXCSC-50CSC-50
20
50
SPTOBID

Sponsor defined tobacco identifier

CIG01a41123
CELLLNCell LineNHK
51123
NRU
TXSLS-110SLS-110
1
51
TRTDMIN
IVTDMINIn vitro Treatment Duration Minimum47.5
42
52123
NRU
TXSLS-110SLS-110
2
52
TRTDTRG
IVTDTRGIn vitro Treatment Duration Target48
43
53123
NRU
TXSLS-110SLS-110
3
53
TRTDMAX
IVTDMAXIn vitro Treatment Duration Maximum48.5
44
54123
NRU
TXSLS-110SLS-110
4
54
TRTDU
IVTDUIn vitro Treatment Duration UnitHOURS
45
55123
NRU
TXSLS-110SLS-110
5
55INCBTMPIncubation Temperature37
46
56123
NRU
TXSLS-110SLS-110
6
56INCBTMPUIncubation Temperature UnitC
47
57123
NRU
TXSLS-110SLS-110
7
57
WAVELGTH
SWAVENMSpectrophotometer
wavelength in nanometers
Wavelength540
48
58123
NRU
TXSLS-110SLS-110
8
58
HUMID
ATMRHPAtmospheric Relative Humidity Percent90
49
59123
NRU
TXSLS-110SLS-110
9
59
ATMCO2
ATMCO2PAtmospheric CO2 Percent5
50
60123
NRU
TXSLS-110SLS-110
10
60
SPTOBID51123NRUTXSLS-110SLS-11011EXPTYP

Exposure Type

Air Liquid Interface52123NRU
SPDEVID

Sponsor defined tobacco identifier

CIG01a
applicant defined device identifierPUFFMASTER3k
61123
TXSLS-110SLS-110
12
61
SAMTYP
SMKRGM
Sample TypeLiquid
Smoking RegimenMEDIUM INTENSITY REGIMEN
62
53
123
NRU
TXSLS-110SLS-110
13
62
INTRVNName of the Intervention ArticleSodium Laurel Sulfate
SPTOBID

Applicant-defined tobacco identifier

CIG01a
63
54
123
NRU
TXSLS-110SLS-110
14
63
ITVTYPEtype of intervention articlePOSITIVE CONTROL
EXPTYP

Exposure Type

Air Liquid Interface
64
55
123
NRU
TXSLS-110SLS-110
15
64
ITVCONC
SAMTYP
intervention concentration
Sample Type
200
Liquid
56
65123
NRU
TXSLS-110SLS-110
16
65
ITVCONCUintervention unitug/ml57123
ITVNAMIntervention Article NameSodium Laurel Sulfate
66123
NRU
TXSLS-110SLS-110
17
66
STRAINStrain/SubstrainCHO
ITVTYPEIntervention Article TypePOSITIVE CONTROL
67
58
123
NRU
TXSLS-110SLS-110
18
67
SPDEVIDSponsor defined device identifierPUFFMASTER3k
ITVCONC

Intervention Article Concentration

110

68
59
123
NRU
TXSLS-110SLS-110
19
68
DUREFIDSmoking RegimeMedium Intensity Regimen
ITVCONCUIntervention Article Concentration Unitug/ml
69
60
123
NRU
TXSLS-110SLS-110
20SPTOBID

Sponsor defined tobacco identifier

CIG01a
69CELLLNCell LineNHK