Versions Compared

Old Version 11

changes.mady.by.user Lou Ann Kramer

Saved on

compared with

New Version Current

changes.mady.by.user Christine Connolly

Saved on

Key

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

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

Info

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

3.42
Expand
titleSample from Report Table

Image Added

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 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)




Sample ID

Smoke Regime

Replicate Number

Plate 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

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

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

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

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

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

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

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

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

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

B


102

75.2

53.3

35.1

11.8

7.74

5.58

3.66

5.34

1.02




030001

Medium

1

2

C


107

79.0

55.0

26.5

10.1

6.06

3.66

1.74

7.02

0.780




030001

Medium

1

2

D


104

80.2

55.3

29.8

8.94

3.90

3.66

Expand
titleStudy 123, Report Table

The following shows the tabulated data as shown in the report for this study: 

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

1.50

6.30

0.

5401-1

780




030001

A
Medium

1

2

7

E

104


101

77

75.

8

7

64

54.

9

1

27

26.7

8

4.

22

86

3

4.

18

38

2

1.

461-1

26

1.02

6.30

0.780

1.02




030001

A
Medium

1

2

8

F

103


110

71

85.

6

7

58

67.

9

7

25

26.0

5

9

.

42

34

4.

14

62

3.

90

42

1.

26

50

4

6.

38

30

0.

780

540

Average




030001

103

Medium

1

2

G


104

77.

4

8

58

64.

1

9

29

27.

0

7

8.

82

22

5

3.

34

18

3

2.

63

46

1.

71

02

5

6.

91

30

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

Expand
titlets.xpt (trial summary, study level parameters)
  • 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

TS1GLPTYPGood Laboratory Practice TypeFDA2123

ALL

TS2GLPTYPGood Laboratory Practice TypeOECD3123ALLTS1STSTDTCStudy Start Date2022-05-25

780




030001

Medium

1

2

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
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
Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123TS1
GLPTYPGood Laboratory Practice TypeFDA
2123TS2
GLPTYPGood Laboratory Practice TypeOECD
3123TS1
GLPFLGLP FlagY
4123TS1
STSTDTCStudy Start Date2022-05-25
5123TS1
STITLEStudy Title

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


6123TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7123TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
8123TS1
APPLCNTApplicantExample Applicant Inc.
9123TS1
APREFIDApplicant Study Reference ID
NOT APPLICABLE
10123TS11TSTFNAMTest Facility NameExample Test Lab Name
11123TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
12123TS11TFCNTRYTest Facility CountryUSA
13123TS11STDIRStudy DirectorDr. R. Smith
14123TS14TSTGDNAMTesting Guideline NamePublication No. 07-4519
15123TS14TSTGDORGTesting Guideline OrganizationNIH
16123TS14TSTGDVERTesting Guideline Version2006-11
17123TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
18123TS1
GNTXAIDGenetic Toxicology Assay IdentifierNRU
19123TS1
SPECIESSpeciesHUMAN
20123TS1
CELLLNCell LineNHK
Dataset wrap
Rowcaps
Rows 1-12:Show the test conditions for the set with a short name or SETCD value of NRU. The applicant chose this value to represent test conditions for the entire assay. 
Rows 13-31: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 row A, well column 3, with a concentration of 50µg/mLof 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 32-50:

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, 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 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.
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
62123TXSLS-110SLS-11062SPTOBID

Applicant-defined tobacco identifier

CIG01a
63123TXSLS-110SLS-11063EXPTYP

Exposure Type

Air Liquid Interface
64123TXSLS-110SLS-11064SAMTYPSample TypeLiquid
65123TXSLS-110SLS-11065ITVNAMIntervention Article NameSodium Laurel Sulfate
66123TXSLS-110SLS-11066ITVTYPEIntervention Article TypePOSITIVE CONTROL
67123TXSLS-110SLS-11067ITVCONC

Intervention Article Concentration

110

68123TXSLS-110SLS-11068ITVCONCUIntervention Article Concentration Unitug/ml
69123TXSLS-110SLS-11069CELLLNCell LineNHK
Dataset wrap
Namerelref

The applicant chose to define the REFID values to indicate the Plate, the Column, and the Row of the wells of the 96-well plate in use, such that the well on plate 2, column 10, row G would assigned a REFID of 2-10-G.

Rowcaps
Row 1:Shows the REFID of 123NRU that indicates the entire assay.
Rows 2-4: Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3, 1-10, 2-10) which have LVLDESC of OBSERVATIONAL SUMMARY.  If this study had recorded summary statistics for an entire trial set (e.g., across both plates for the same dose level), there would be an additional REFID for the trial set (with a LVLDESC of TRIAL SET).
Rows 5-6:Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units that are also observational units within the SETCD of CSC-50b that have the parent REFID of 123NRU.
Rows 7-8:Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units that are also observational units within the SETCD of CSC-50 that have the parent REFID of 1-3.
Row 9:Shows the REFID of 1-10-G that indicates the experimental unit that is also an observational unit within the SETCD of SLS-110 that has the parent REFID of 1-10.
Row 10: Shows the REFID of 2-10-G that indicates the experimental unit that is also an observational unit within the SETCD of SLS-110 that has the parent REFID of 2-10.
Dataset2
tableidrelref
Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1123

NRU

123NRU
1ASSAY
2123CSC-501-3123NRU2OBSERVATIONAL SUMMARY
3123SLS-1101-10123NRU2OBSERVATIONAL SUMMARY
4123SLS-1102-10123NRU2OBSERVATIONAL SUMMARY
5123

CSC-50b

1-3-A

123NRU

2EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
6123

CSC-50b

1-3-H123NRU2EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
7123CSC-501-3-B1-33EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
8123CSC-501-3-C1-33EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
9123SLS-1101-10-G1-103EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
10123SLS-1102-10-G2-103EXPERIMENTAL UNIT/OBSERVATIONAL UNIT
  • 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
0.780
Dataset wrap
Namegt

Certain data (Absorbance Reading and Background Corrected Absorbance Reading) are not shown in the sample report table above but are included here for completeness of the NRU assay.

Rowcaps
Rows 1-3:Show the experimental unit data for GTREFID 1-3-B. 
Rows 4-6:Show the experimental unit data for GTREFID 1-3-C.
Rows 7-9:Show the data for the entire trial set, GTREFID=1-3.
Rows 10-12:Show the experimental unit data for GTREFID 1-10-G
Rows 13-15:Show the data for the entire trial set, GTREFID=1-10
Rows 16-18:Show the experimental unit data for GTREFID 2-10-G. 
Rows 19-21:Show the data for the entire trial set, GTREFID=2-10
Row 22:Shows the data for the entire assay, GTREFID=123NRU.
Dataset2
RowSTUDYIDDOMAINGTSEQGTREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRTGTSTRESCGTSTRESNGTSTRESU
1123GT11-3-BABSORBAbsorbance Reading1.7

1.71.7
2123GT21-3-BBKCABSBackground Corrected Absorbance Reading

1.6



1.61.6
3123GT31-3-BRELABSRelative Absorbance Reading77.7

77.777.7
4123GT41-3-CABSORBAbsorbance Reading1.8

1.81.8
5123GT51-3-CBKCABSBackground Corrected Absorbance Reading

1.7



1.71.7
6123GT61-3-CRELABSRelative Absorbance Reading77.4

77.477.4
7123GT71-3RELABSRelative Absorbance Reading78.2%MEAN78.278.2%
8123GT81-3RELABSRelative Absorbance Reading2.9%STANDARD DEVIATION2.92.9%
9123GT91-3RELABSRelative Absorbance Reading3.6
COEFFICIENT OF VARIANCE3.63.6
10123GT101-10-GABSORBAbsorbance Reading0.7

0.70.7

11

123GT111-10-GBKCABSBackground Corrected Absorbance Reading

0.6



0.6

0.6


12123GT121-10-GRELABSRelative Absorbance Reading8.57

8.578.57
13123GT131-10RELABSRelative Absorbance Reading

8.94

%MEAN

8.94

8.94


14123GT141-10RELABSRelative Absorbance Reading

2.72

%

STANDARD DEVIATION

2.72

2.72


15123GT151-10RELABSRelative Absorbance Reading

30.5


COEFFICIENT OF VARIANCE

30.5

30.5


16123GT162-10-GABSORBAbsorbance Reading0.9




17123GT172-10-GBKCABSBackground Corrected Absorbance Reading

0.8






18123GT182-10-GRELABSRelative Absorbance Reading6.30

6.306.30
19123GT192-10RELABSRelative Absorbance Reading

5.91

%MEAN

5.91

5.91


20123GT202-10RELABSRelative Absorbance Reading

0.83

%

STANDARD DEVIATION

0.83

0.83


21123GT212-10RELABSRelative Absorbance Reading

14.1


COEFFICIENT OF VARIANCE

14.1

14.1


22123GT22123NRU

EC50CYTX

Effective Concentration of 50 Percent Cytotoxicity123ug/ml
123123ug/ml
4123ALLTS1STITLEStudy 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

5123ALLTS1SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.06123

ALL

TS1SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-307123ALLTS1SSPONSORSponsor OrganizationExample Sponsor Inc.8123ALLTS1SPREFIDSponsor's Study Reference IDNOT APPLICABLE9123ALLTS11TSTFNAMTest Facility NameExample Tox Lab Name10123

ALL

TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 1000011123ALLTS11TFCNTRYTest Facility CountryUSA...123ALLTS11STDIRStudy DirectorDr. R. Smith123ALLTS1GLPFLGLP FlagY123MNvitTS1ASTDAssay StandardOECD Test No. 487 123MNvitTS1ASTDVAssay Standard Version2016-07-29123MNvitTS1SSTYPStudy TypeGENOTOXICITY IN VITRO123MNvitTS1SSSTYPStudy Sub TypeIn Vitro Micronucleus123MNvitTS1SPECIESSpeciesHomo Sapiens123MNvitTS1??Test System?TK6 Lymphoblastoid Suspension Cells123NRUTS1ASTDAssay StandardNIH Publication No. 07-4519123NRUTS1ASTDVAssay Standard Version2006-11123NRUTS1SSTYPStudy TypeGENOTOXICITY IN VITRO123NRUTS1SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake123NRUTS1SPECIESSpeciesSalmonella enterica 123NRUTS1??Test System??Normal Human Keratinocyte
Expand
titletx.xpt (trial sets)
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)
11 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-10INTRVNname of the intervention articleCigarette Smoke Condensate4123NRUTX1-1-ACSC-10ITVTYPE
(CT e.g, Product, positive control, negative control)
type of intervention articlePRODUCT5123NRUTX1-1-ACSC-10ITVCONCintervention concentration106123NRUTX1-1-ACSC-10ITVCONCUintervention unitug/ml123NRU1STRAINStrain/SubstrainSalmonella enterica enterica123NRU1REGIMESmoking RegimeTraditional combustible 123NRU1RUN

Assay run number (how is this different from REPNUM)

1

123NRU1PORTPort ID1123NRU1SMPLIDSample ID030001123NRU1SMKFRCSmoke FractionA123NRU1REPNUMReplicate Number111123NRUTX1-1-BCSC-10ITVCONCintervention concentration1012123NRUTX1-1-BCSC-10ITVCONCUintervention unitug/ml......123NRUTX1-10-HSLS-10PLATENUMPlate number1  123NRUTX1-10-HSLS-10WELLNUMNumber representing the location of the well in the 96-well plate10-H123NRUTX1-10-HSLS-10INTRVNname of the intervention articlesodium laurel sulfate123NRUTX1-10-HSLS-10ITVTYPEtype of intervention articlePOSITIVE CONTROL123NRUTX1-10-HSLS-10ITVCONCintervention concentration200123NRUTX1-10-HSLS-10ITVCONCUintervention unitug/ml......123NRUTX2-10-HSLS-10PLATENUMPlate number2123NRUTX2-10-HSLS-10WELLNUMNumber representing the location of the well in the 96-well plate10-H123NRUTX2-10-HSLS-10INTRVNname of the intervention articlesodium laurel sulfate123NRUTX2-10-HSLS-10ITVTYPEtype of intervention articlePOSITIVE CONTROL123NRUTX2-10-HSLS-10ITVCONCintervention concentration200123NRUTX2-10-HSLS-10ITVCONCUintervention unitug/ml
Expand
titlegt.xpt (similar to LB)

Image RemovedImage Removed

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 Reading96.9123NRUGT1-1-G1RELABSRelative Absorbance Reading105123NRUGT1-1-H1RELABSRelative Absorbance Reading95.210123NRUGT1-2-A1RELABSRelative Absorbance Reading

83.0

11123NRUGT1-2-B1RELABSRelative Absorbance Reading77.7......80123NRUGT1-10-H1RELABSRelative Absorbance Reading0.791......160123NRUGT2-10-H1RELABSRelative Absorbance Reading