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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
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in example study 123.neutral red uptake (NRU) cytotoxicity assay in example study 123.

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titleSample from Report Table

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The following shows example data

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titleSample from Report Table

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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 NHK cells. 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)

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
Rowcaps
two Types 8 the sponsor's study reference ID is not applicable 912:Show that TSGRPID has been used to link records (name, 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.
Dataset2
Dataset2

Row

STUDYID

GNTXAID

DOMAIN

TSSEQ

Row

STUDYID

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
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
TS14
ASTDVAssay Standard Version
TSTGDORGTesting Guideline OrganizationNIH
2006-11

16123
NRU
TS1
SSTYP
4
Study TypeGENOTOXICITY IN VITRO
TSTGDVERTesting Guideline Version2006-11
17123
NRU
TS1
SSSTYP

SSTYPStudy
Sub
Type
In Vitro Neutral Red Uptake
GENOTOXICITY IN VITRO
18123TS1
GNTXAIDGenetic Toxicology Assay IdentifierNRU
19123TS1
SPECIESSpecies
Human
HUMAN
19

20123
NRU
TS1
CELLLNCell LineNHK
Dataset wrap
Rowcaps
Rows 1-12:

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Rowcaps
Rows 1-12:Show the test conditions for the set with a short name or SETCD value of ALLNRU.   The sponsor 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 sponsor applicant chose this value to represent plate number 1, well row A, well number 1column 3, with a concentration of 50µg/mLof Cigarette Smoke Condensate 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 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 sponsor applicant chose this value to represent plate number 1, well number 2, with a rows B-G, well column 3 and plate number 2, well rows A-H, well column 3. These all have the concentration of 50µg/mLof Cigarette Smoke Condensate 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 sponsor 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.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
13123TXCSC-50bCSC-50-blank13IVTDMINIn vitro Treatment Duration Minimum47.5
14123TXCSC-50bCSC-50-blank14IVTDTRGIn vitro Treatment Duration Target48
15123TXCSC-50bCSC-50-blank15IVTDMAXIn vitro Treatment Duration Maximum48.5
16123TXCSC-50bCSC-50-blank16IVTDUIn vitro Treatment Duration UnitHOURS
17123TXCSC-50bCSC-50-blank17INCBTMPIncubation Temperature37
18123TXCSC-50bCSC-50-blank18INCBTMPUIncubation Temperature UnitC
19123TXCSC-50bCSC-50-blank19SWAVENMSpectrophotometer Wavelength540
20123TXCSC-50bCSC-50-blank20ATMRHPAtmospheric Relative Humidity Percent90
21123TXCSC-50bCSC-50-blank21ATMCO2PAtmospheric CO2 Percent5
22123TXCSC-50bCSC-50-blank22SPDEVIDapplicant defined device identifierPUFFMASTER3k
23123TXCSC-50bCSC-50-blank23SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
24123TXCSC-50bCSC-50-blank24SPTOBID

Applicant-defined tobacco identifier

CIG01a
25123TXCSC-50bCSC-50-blank25EXPTYP

Exposure Type

Air Liquid Interface
26123TXCSC-50bCSC-50-blank26SAMTYPSample TypeWhole Smoke Conditioned Media
27123TXCSC-50bCSC-50-blank27ITVNAMName of the Intervention ArticleTobacco ProdA
28123TXCSC-50bCSC-50-blank28ITVTYPEIntervention Article TypePRODUCT
29123TXCSC-50bCSC-50-blank29ITVCONC

Intervention Article Concentration

50
30123TXCSC-50bCSC-50-blank30ITVCONCUIntervention Article Concentration Unitug/ml
31123TXCSC-50bCSC-50-blank31CELLLNCell LineNOT APPLICABLE
32123TXCSC-50CSC-5032IVTDMINIn vitro Treatment Duration Minimum47.5
33123TXCSC-50CSC-5033IVTDTRGIn vitro Treatment Duration Target48
34123TXCSC-50CSC-5034IVTDMAXIn vitro Treatment Duration Maximum48.5
35123TXCSC-50CSC-5035IVTDUIn vitro Treatment Duration UnitHOURS
36123TXCSC-50CSC-5036INCBTMPIncubation Temperature37
37123TXCSC-50CSC-5037INCBTMPUIncubation Temperature UnitC
38123TXCSC-50CSC-5038SWAVENMSpectrophotometer Wavelength540
39123TXCSC-50CSC-5039ATMRHPAtmospheric Relative Humidity Percent90
40123TXCSC-50CSC-5040ATMCO2PAtmospheric CO2 Percent5
41123TXCSC-50CSC-5041SPDEVIDapplicant defined device identifierPUFFMASTER3k
42123TXCSC-50CSC-5042SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
43123TXCSC-50CSC-5043SPTOBID

Applicant-defined tobacco identifier

CIG01a
44123TXCSC-50CSC-5044EXPTYP

Exposure Type

Air Liquid Interface
45123TXCSC-50CSC-5045SAMTYPSample TypeWhole Smoke Conditioned Media
46123TXCSC-50CSC-5046ITVNAMIntervention Article NameTobacco ProdA
47123TXCSC-50CSC-5047ITVTYPEIntervention Article TypePRODUCT
48123TXCSC-50CSC-5048ITVCONC

Intervention Article Concentration

50
49123TXCSC-50CSC-5049ITVCONCUIntervention Article Concentration Unitug/ml
50123TXCSC-50CSC-5050CELLLNCell LineNHK
51123TXSLS-110SLS-11051IVTDMINIn vitro Treatment Duration Minimum47.5
52123TXSLS-110SLS-11052IVTDTRGIn vitro Treatment Duration Target48
53123TXSLS-110SLS-11053IVTDMAXIn vitro Treatment Duration Maximum48.5
54123TXSLS-110SLS-11054IVTDUIn vitro Treatment Duration UnitHOURS
55123TXSLS-110SLS-11055INCBTMPIncubation Temperature37
56123TXSLS-110SLS-11056INCBTMPUIncubation Temperature UnitC
57123TXSLS-110SLS-11057SWAVENMSpectrophotometer Wavelength540
58123TXSLS-110SLS-11058ATMRHPAtmospheric Relative Humidity Percent90
59123TXSLS-110SLS-11059ATMCO2PAtmospheric CO2 Percent5
60123TXSLS-110SLS-11060SPDEVIDapplicant defined device identifierPUFFMASTER3k
61123TXSLS-110SLS-11061SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
62123
Dataset2
RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123NRUTXALLALL_ASSAY1TRTDMINTreatment Duration Minimum47.5
2123NRUTXALLALL_ASSAY

2

TRTDTRGTreatment Duration Target48
3123NRUTXALLALL_ASSAY3TRTDMAXTreatment Duration Maximum48.5
4123NRUTXALLALL_ASSAY4TRTDUTreatment Duration UnitHOURS
5123NRUTXALLALL_ASSAY5INCBTMPIncubation Temperature37
6123NRUTXALLALL_ASSAY6INCBTMPUIncubation Temperature UnitC
7123NRUTXALLALL_ASSAY7WAVELGTHSpectrophotometer wavelength in nanometers540
8123NRUTXALLALL_ASSAY8HUMIDAtmospheric Relative Humidity Percent90
9123NRUTXALLALL_ASSAY9ATMCO2Atmospheric CO2 Percent5
10123NRUTXALLALL_ASSAY10SPDEVIDSponsor defined device identifierPUFFMASTER3k
11123NRUTXALLALL_ASSAY11DUREFIDSmoking RegimeMedium Intensity Regimen
12123NRUTXALLALL_ASSAY12SPTOBID

Sponsor 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-blank16INTRVNName of the Intervention ArticleTobacco ProdA
17123NRUTXCSC-50bCSC-50-blank17ITVTYPEtype of intervention articlePRODUCT
18123NRUTXCSC-50bCSC-50-blank18ITVCONCintervention concentration50
19123NRUTXCSC-50bCSC-50-blank19ITVCONCUintervention 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-5024INTRVNName of the Intervention ArticleTobacco ProdA
25123NRUTXCSC-50CSC-5025ITVTYPEtype of intervention articlePRODUCT
26123NRUTXCSC-50CSC-5026ITVCONCintervention concentration50
27123NRUTXCSC-50CSC-5027ITVCONCUintervention unitug/ml
28123NRUTXCSC-50CSC-5028CELLLNCell LineNHK
29123
TXSLS-110SLS-110
29
62
PSETCD

Parent Set Code

ALL30123
SPTOBID

Applicant-defined tobacco identifier

CIG01a
63123
NRU
TXSLS-110SLS-110
30
63EXPTYP

Exposure Type

Air Liquid Interface
31
64123
NRU
TXSLS-110SLS-110
31
64SAMTYPSample TypeLiquid
32
65123
NRU
TXSLS-110SLS-110
32
65
INTRVN
ITVNAM
Name of the
Intervention Article NameSodium Laurel Sulfate
33
66123
NRU
TXSLS-110SLS-110
33
66ITVTYPE
type of intervention article
Intervention Article TypePOSITIVE CONTROL
34
67123
NRU
TXSLS-110SLS-110
34
67ITVCONC
intervention concentration20035

Intervention Article Concentration

110

68123
NRU
TXSLS-110SLS-110
35
68ITVCONCU
intervention unit
Intervention Article Concentration Unitug/ml
36
69123
NRU
TXSLS-110SLS-110
36
69CELLLNCell LineNHK