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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
  • purple font - remaining questions to resolve

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

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
  • Sponsor should be "applicant", how do we represent this?  In text explanation in the IG?  In definition in CT/Parmcd/Parm?
  • TK6, human keratinocyte, is this "test system"?
  • Can we draft a starting list of Study Types and Sub Types to submit to CT now?
  • Is there a dictionary of species and/or strain that we would use? (see example)

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123NRUTS1
GLPTYPGood Laboratory Practice TypeFDA
2123NRUTS2
GLPTYPGood Laboratory Practice TypeOECD
3123NRUTS1
STSTDTCStudy Start Date2022-05-25
4123NRUTS1
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


5123NRUTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123NRUTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123NRUTS1
SSPONSORSponsor Applicant's OrganizationExample Applicant Inc.
8123NRUTS1
SPREFIDSponsor's Applicant's Study Reference ID
NOT APPLICABLE
9123NRUTS11TSTFNAMTest Facility NameExample Tox Testing Lab Name
10123NRUTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123NRUTS11TFCNTRYTest Facility CountryUSA
12123NRUTS11STDIRStudy DirectorDr. R. Smith
13123NRUTS1
GLPFLGLP FlagY
14123NRUTS1
ASTDAssay StandardNIH Publication No. 07-4519
15123NRUTS1
ASTDVAssay Standard Version2006-11
16123NRUTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17123NRUTS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake
18123NRUTS1
SPECIESSpeciesSalmonella enterica 
19123NRUTS1
??Test System??TK6 Normal Human Keratinocyte
  • 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 applicant designations as specified in the trial design.
  • 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
  • Where are the details of the smoke regime defined/submitted today? (e.g., puff profile = Bell shaped puffing volumes; Puff Block = 50%, etc.)
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
7123NRUTX1-1-ACSC-10
STRAINStrain/SubstrainSalmonella enterica enterica
8123NRUTX1-1-ACSC-10
REGIMESmoking RegimeTraditional combustible 
9123NRUTX1-1-ACSC-10
RUN

Assay run number

1

10

123NRUTX1-1-ACSC-10
PORTPort ID1
11123NRUTX1-1-ACSC-10
SMPLIDSample ID030001
12123NRUTX1-1-ACSC-10
SMKFRCSmoke FractionA
13123NRUTX1-1-ACSC-10
REPNUMReplicate Number1
1123NRUTX1-1-BCSC-10
PLATENUM. (e.g., 1 or 2)
1
2123NRUTX1-1-BCSC-10
WELLNUM (e.g., 1-A through 10-H)
Number representing the location of the well in the 96-well plate1-A 
3123NRUTX1-1-BCSC-10
INTRVNname of the intervention articleCigarette Smoke Condensate
4123NRUTX1-1-BCSC-10
ITVTYPE
(CT e.g, Product, positive control, negative control)
type of intervention articlePRODUCT
5123NRUTX1-1-BCSC-10
ITVCONCintervention concentration10
6123NRUTX1-1-BCSC-10
ITVCONCUintervention unitug/ml
7123NRUTX1-1-BCSC-10
STRAINStrain/SubstrainSalmonella enterica enterica
8123NRUTX1-1-BCSC-10
REGIMESmoking RegimeTraditional combustible 
9123NRUTX1-1-BCSC-10
RUN

Assay run number

1

10

123NRUTX1-1-BCSC-10
PORTPort ID1
11123NRUTX1-1-BCSC-10
SMPLIDSample ID030001
12123NRUTX1-1-BCSC-10
SMKFRCSmoke FractionA
13123NRUTX1-1-BCSC-10
REPNUMReplicate Number1




















14123NRUTX1-1-BCSC-10
ITVCONCintervention concentration10
15123NRUTX1-1-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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