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This example shows trial design and results data for in vitro Neutral Red Cytotoxicity Assay, Relative Absorbance.

Note that Variable Names and Domain abbreviations may change (have not been checked against existing and are not vetted)

  • red font - indicates potential for CT code lists
  • green font - links to other domains

The following shows the tabulated data as it is represented in a report for this study and includes summary statistics (e.g. Average, Standard Deviation, Coeff. Var.). Statistics are not included in the SEND standard: 

Neutral Red Cytotoxicity Assay Results (Relative Absorbance Data)

Run-Port Number

Sample ID

Smoke Fraction

Replicate Number

Plate Number

Well Number

Relative Assay Plate Absorbance Readings

Cigarette Smoke Condensate (µg/mL)

SLS (µg/mL)

10

50

75

100

120

140

160

200

110

200

1-1

030001

A

1

1

1

100

83.0

56.7

29.5

13.0

8.57

4.44

1.76

13.7

0.547

1-1

030001

A

1

1

2

107

77.7

65.7

30.2

15.6

9.79

5.41

2.49

8.09

0.791

1-1

030001

A

1

1

3

98.6

77.4

57.7

35.8

8.09

7.36

3.22

0.791

6.38

0.061

1-1

030001

A

1

1

4

94.9

81.5

38.2

31.2

7.60

5.17

3.22

0.791

5.17

0.304

1-1

030001

A

1

1

5

111

78.1

64.5

32.9

8.82

5.90

2.74

1.28

10.3

0.547

1-1

030001

A

1

1

6

96.6

76.2

48.0

26.8

7.84

4.20

2.74

1.52

8.09

4.93

1-1

030001

A

1

1

7

105

77.9

58.2

28.3

8.09

4.68

1.76

0.547

8.57

1.76

1-1

030001

A

1

1

8

95.2

74.0

47.2

24.4

8.57

3.71

3.47

0.304

11.2

0.791

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

1-1

030001

A

1

2

1

93.4

74.0

56.0

35.1

11.8

8.70

5.10

1.98

5.34

1.02

1-1

030001

A

1

2

2

102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02

1-1

030001

A

1

2

3

107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780

1-1

030001

A

1

2

4

104

80.2

55.3

29.8

8.94

3.90

3.66

1.50

6.30

0.780

1-1

030001

A

1

2

5

101

75.7

54.1

26.7

4.86

4.38

1.26

1.02

6.30

1.02

1-1

030001

A

1

2

6

110

85.7

67.7

26.0

5.34

4.62

3.42

1.50

6.30

0.540

1-1

030001

A

1

2

7

104

77.8

64.9

27.7

8.22

3.18

2.46

1.02

6.30

0.780

1-1

030001

A

1

2

8

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

  • Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data. 
  • Assumption: A Trial (study) can have more than one assay type
  • Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study
  • BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123

ALL

TS1
GLPTYPGood Laboratory Practice TypeFDA
2123

ALL

TS2
GLPTYPGood Laboratory Practice TypeOECD
3123ALLTS1
STSTDTCStudy Start Date2022-05-25
4123ALLTS1
STITLEStudy Title

Determination of the in vitro genotoxicity potential of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake


5123ALLTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123

ALL

TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123ALLTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
8123ALLTS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
9123ALLTS11TSTFNAMTest Facility NameExample Tox Lab Name
10123

ALL

TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123ALLTS11TFCNTRYTest Facility CountryUSA
...123ALLTS11STDIRStudy DirectorDr. R. Smith

123ALLTS1
GLPFLGLP FlagY

123MNvitTS1
ASTDAssay StandardOECD Test No. 487 

123MNvitTS1
ASTDVAssay Standard Version2016-07-29

123MNvitTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO

123MNvitTS1
SSSTYPStudy Sub TypeIn Vitro Micronucleus

123MNvitTS1
SPECIESSpeciesHomo Sapiens

123MNvitTS1
??Test System?TK6 Lymphoblastoid Suspension Cells

123NRUTS1
ASTDAssay StandardNIH Publication No. 07-4519

123NRUTS1
ASTDVAssay Standard Version2006-11

123NRUTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO

123NRUTS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake

123NRUTS1
SPECIESSpeciesSalmonella enterica 

123NRUTS1
??Test System??Normal Human Keratinocyte
  • During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled;  For now, we just include good example values based on our experience
  • Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
  • BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
  • Where is TK6 cell type?  is this test system (see below)
    • needs to be allowed to vary down to the well level / result level
RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL
1123NRUTX1-1-A
(plate-col-row in the 96-well plate)
CSC-10
(through SLS-200)

PLATENUM. (e.g., 1 or 2)
1
2123NRUTX1-1-ACSC-10
WELLNUM (e.g., 1-A through 10-H)
Number representing the location of the well in the 96-well plate1-A 
3123NRUTX1-1-ACSC-10
INTRVNname of the intervention articleCigarette Smoke Condensate
4123NRUTX1-1-ACSC-10
ITVTYPE
(CT e.g, Product, positive control, negative control)
type of intervention articlePRODUCT
5123NRUTX1-1-ACSC-10
ITVCONCintervention concentration10
6123NRUTX1-1-ACSC-10
ITVCONCUintervention unitug/ml

123NRU
1

STRAINStrain/SubstrainSalmonella enterica enterica

123NRU
1

REGIMESmoking RegimeTraditional combustible 

123NRU
1

RUN

Assay run number (how is this different from REPNUM)

1


123NRU
1

PORTPort ID1

123NRU
1

SMPLIDSample ID030001

123NRU
1

SMKFRCSmoke FractionA

123NRU
1

REPNUMReplicate Number1
11123NRUTX1-1-BCSC-10
ITVCONCintervention concentration10
12123NRUTX1-1-BCSC-10
ITVCONCUintervention unitug/ml
...


...





123NRUTX1-10-HSLS-10
PLATENUMPlate number1  

123NRUTX1-10-HSLS-10
WELLNUMNumber representing the location of the well in the 96-well plate10-H

123NRUTX1-10-HSLS-10
INTRVNname of the intervention articlesodium laurel sulfate

123NRUTX1-10-HSLS-10
ITVTYPEtype of intervention articlePOSITIVE CONTROL

123NRUTX1-10-HSLS-10
ITVCONCintervention concentration200

123NRUTX1-10-HSLS-10
ITVCONCUintervention unitug/ml
...


...





123NRUTX2-10-HSLS-10
PLATENUMPlate number2

123NRUTX2-10-HSLS-10
WELLNUMNumber representing the location of the well in the 96-well plate10-H

123NRUTX2-10-HSLS-10
INTRVNname of the intervention articlesodium laurel sulfate

123NRUTX2-10-HSLS-10
ITVTYPEtype of intervention articlePOSITIVE CONTROL

123NRUTX2-10-HSLS-10
ITVCONCintervention concentration200

123NRUTX2-10-HSLS-10
ITVCONCUintervention unitug/ml

RowSTUDYIDASSAYIDDOMAINTXCDGTSEQGTTESTCDGTTESTGTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESU
1123NRUGT1-1-A1RELABSRelative Absorbance Reading100ug/ml100100ug/ml
2123NRUGT1-1-B1RELABSRelative Absorbance Reading107ug/ml100100ug/ml
3123NRUGT1-1-C1RELABSRelative Absorbance Reading98.6ug/ml100100ug/ml
4123NRUGT1-1-D1RELABSRelative Absorbance Reading94.9ug/ml100100ug/ml
5123NRUGT1-1-E1RELABSRelative Absorbance Reading111ug/ml111111ug/ml

123NRUGT1-1-F1RELABSRelative Absorbance Reading96.9ug/ml96.996.9ug/ml

123NRUGT1-1-G1RELABSRelative Absorbance Reading105ug/ml105105ug/ml

123NRUGT1-1-H1RELABSRelative Absorbance Reading95.2ug/ml95.295.2ug/ml
10123NRUGT1-2-A1RELABSRelative Absorbance Reading

83.0

ug/ml83.083.0ug/ml
11123NRUGT1-2-B1RELABSRelative Absorbance Reading77.7

ug/ml

77.777.7ug/ml
...


...







80123NRUGT1-10-H1RELABSRelative Absorbance Reading0.791ug/ml0.7910.791ug/ml
...


...







160123NRUGT2-10-H1RELABSRelative Absorbance Reading0.780ug/ml0.7800.780ug/ml
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