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This example shows sample raw dataa report table, trial design, and results data for the in vitro Neutral Red Uptake Cytotoxicity Assay. neutral red uptake (NRU) cytotoxicity assay in example study 123.

3.42
Expand
titleStudy 123, Sample from Report Table

The following shows the tabulated data as it is represented example data for study 123 in a report for this studytable.   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. 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

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)

EC50 (µg/ml)

0

10

50

75

100

120

140

160

200

110

200

0

1-1

030001

A

1

1

1

0.046

0.046*0.039*0.012*0.030*0.003*0.057*0.032*0.003*0.050*0.044*

0.040

1-1

030001

A

1

1

2

0.048

107

77.7

65.7

30.2

15.6

9.79

5.41

2.49

8.09

0.791

0.014

1-1

030001

A

1

1

3

0.005

98.6

77.4

57.7

35.8

8.09

7.36

3.22

0.791

6.38

0.061

0.050

1-1

030001

A

1

1

4

0.049

94.9

81.5

38.2

31.2

7.60

5.17

3.22

0.791

5.17

0.304

0.017

1-1

030001

A

1

1

5

0.047

111

78.1

64.5

32.9

8.82

5.90

2.74

1.28

10.3

0.547

0.011

1-1

030001

A

1

1

6

0.032

96.6

76.2

48.0

26.8

7.84

4.20

2.74

1.52

8.09

4.93

0.022

1-1

030001

A

1

1

7

0.044

105

77.9

58.2

28.3

8.09

4.68

1.76

0.547

8.57

1.76

0.056

1-1

030001

A

1

1

8

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

*non-treated control wells

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

Medium

1

2

G


104

103

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

Coeff. Var.

4.6

5.6

9.2

13.6

29.8

36.9

37.6

50.0

14.1

20.2

30

0.

840

Std. Dev.

5

4.4

5.3

4.0

2.63

1.97

1.37

0.86

0.83

0.170

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).

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

 













123

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

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123NRUTS1GLPTYPGood Laboratory Practice TypeFDA2123NRUTS2GLPTYPGood Laboratory Practice TypeOECD3123NRUTS1STSTDTCStudy Start Date2022-05-254123NRUTS1STITLEStudy Title

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

5123NRUTS
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
ATMCO2
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_ASSAY9ATMCO2P
1SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.06123NRUTS1SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-307123NRUTS1SSPONSORSponsor OrganizationExample Applicant Inc.8123NRUTS1SPREFIDSponsor Study Reference IDNOT APPLICABLE9123NRUTS11TSTFNAMTest Facility NameExample Tox Testing Lab Name10123NRUTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 1000011123NRUTS11TFCNTRYTest Facility CountryUSA12123NRUTS11STDIRStudy DirectorDr. R. Smith13123NRUTS1GLPFLGLP FlagY14123NRUTS1ASTDAssay StandardNIH Publication No. 07-451915123NRUTS1ASTDVAssay Standard Version2006-1116123NRUTS1SSTYPStudy TypeGENOTOXICITY IN VITRO17123NRUTS1SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake18123NRUTS1SPECIESSpeciesHamster19123NRUTS1TESTSYSTest SystemCHO
Expand
titletx.xpt (trial sets)
  • 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.)
  • Smoke fraction?  is this indicator of processing of material from smoke machine..we used Smoke Exposure System - ok?
  • Incubate cells (37 ºC ±1 ºC, 90% ±10% humidity, and 5% ±1% CO2/air) - these are ranges, do we model for ranges?
RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL
1123NRUTXCSC-50CSC-501TRTDMINTreatment Duration Minimum47.5
2123NRUTXCSC-50CSC-502TRTDTRGTreatment Duration Target48
3123NRUTXCSC-50CSC-503TRTDMAXTreatment Duration Maximum48.5
4123NRUTXCSC-50CSC-504TRTDUTreatment Duration UnitHOURS
5123NRUTXCSC-50CSC-505INCBTMPIncubation Temperature37
6123NRUTXCSC-50CSC-506INCBTMPUIncubation Temperature UnitC
7123NRUTXCSC-50CSC-507WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS540
8123NRUTXCSC-50CSC-508HUMIDAtmospheric Relative Humidity  Percent90
9123NRUTXCSC-50CSC-509
Atmospheric CO2 Percent5
10123
NRU
TX
CSC-50
NRUNRU_ASSAY
CSC-50
10
SPTOBID
SPDEVID
Sponsor
applicant defined
tobacco
device identifier
CIG01a
PUFFMASTER3k
11123
NRU
TX
CSC-50
NRUNRU_ASSAY
CSC-50
11
EXPTYP
SMKRGM

Exposure Type

Smoking RegimenMEDIUM INTENSITY REGIMEN
Air Liquid Interface
12123
NRU
TX
CSC-50
NRUNRU_ASSAY
CSC-50
12
SAMTYPSample Type
SPTOBID

Applicant-defined tobacco identifier

CIG01a
Whole Smoke Conditioned Media
13123
NRU
TXCSC-
50
50bCSC-50-blank13
INTRVNName of the Intervention Article
IVTDMINIn vitro Treatment Duration Minimum47.5
Tobacco ProdA
14123
NRU
TXCSC-
50
50bCSC-50-blank14
ITVTYPE
(CT e.g, Product, positive control, negative control, vehicle control, solvent control)
type of intervention article
IVTDTRGIn vitro Treatment Duration Target48
PRODUCT 
15123
NRU
TXCSC-
50
50bCSC-50-blank15
ITVCONCintervention concentration
IVTDMAXIn vitro Treatment Duration Maximum48.5
50
16123
NRU
TXCSC-
50
50bCSC-50-blank16
ITVCONCUintervention unit
IVTDUIn vitro Treatment Duration UnitHOURS
ug/ml
17123
NRU
TXCSC-
50
50bCSC-50-blank17
STRAINStrain/SubstrainCHO
INCBTMPIncubation Temperature37
18123
NRU
TXCSC-
50
50bCSC-50-blank18
SPDEVIDSponsor defined device identifier
INCBTMPUIncubation Temperature UnitC
PUFFMASTER3k
19123
NRU
TXCSC-
50
50bCSC-50-blank19
DUREFID
SWAVENM
Smoking Regime
Spectrophotometer Wavelength540
Medium Intensity Regimen
20123
NRU
TXCSC-
50
50bCSC-50-blank20
SPTOBID

Sponsor defined tobacco identifier

ATMRHPAtmospheric Relative Humidity Percent90
CIG01a
21123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
147.
21
TRTDMINTreatment Duration Minimum
ATMCO2PAtmospheric CO2 Percent
5
22123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
2
22
TRTDTRGTreatment Duration Target
SPDEVIDapplicant defined device identifierPUFFMASTER3k
48
23123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
3
23
TRTDMAXTreatment Duration Maximum
SMKRGMSmoking RegimenMEDIUM INTENSITY REGIMEN
48.5
24123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
4
24
TRTDUTreatment Duration Unit
SPTOBID

Applicant-defined tobacco identifier

CIG01a
HOURS
25123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
5
25
INCBTMP
EXPTYP
Incubation Temperature

Exposure Type

Air Liquid Interface
37
26123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
6
26
INCBTMPUIncubation Temperature Unit
SAMTYPSample TypeWhole Smoke Conditioned Media
C
27123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
7
27
WAVELGTHSpectrophotometer  WAVELENGTH IN NANOMETERS
ITVNAMName of the Intervention ArticleTobacco ProdA
540
28123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
8
28
HUMIDAtmospheric Relative Humidity  Percent
ITVTYPEIntervention Article TypePRODUCT
90
29123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
9
29
ATMCO2Atmospheric CO2 Percent
ITVCONC

Intervention Article Concentration

50
5
30123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
10
30
SPTOBID

Sponsor defined tobacco identifier

ITVCONCUIntervention Article Concentration Unitug/ml
CIG01a
31123
NRU
TX
SLS
CSC-
110
50b
SLS
CSC-50-
110
blank
11EXPTYP

Exposure Type

Air Liquid Interface32123NRUTXSLS-110SLS-11012SAMTYPSample TypeLiquid33123NRUTXSLS-110SLS-11013INTRVNName of the Intervention ArticleSodium Laurel Sulfate34123NRUTXSLS-110SLS-11014ITVTYPE
(CT e.g, Product, positive control, negative control, vehicle control, solvent control)
type of intervention articlePOSITIVE CONTROL35123NRUTXSLS-110SLS-11015ITVCONCintervention concentration20036123NRUTXSLS-110SLS-11016ITVCONCUintervention unitug/ml37123NRUTXSLS-110SLS-11017STRAINStrain/SubstrainCHO38123NRUTXSLS-110SLS-11018SPDEVIDSponsor defined device identifierPUFFMASTER3k39123NRUTXSLS-110SLS-11019DUREFIDSmoking RegimeMedium Intensity Regimen40123NRUTXSLS-110SLS-11020SPTOBID

Sponsor defined tobacco identifier

CIG01a Expand
titleou.xpt Observational and Experimental Units Domain
Image Removed

relref.xpt

Row

STUDYID

ASSAYID

SETCD

REFID

PARENT

LEVEL

1123NRUALL123NRU12123NRUCSC-501-3123NRU23123NRUCSC-501-3-B1-334123NRUCSC-501-3-C1-335123NRUSLS-1101-10123NRU26123NRUSLS-1102-10123NRU27123NRUSLS-1101-10-G1-1038123NRUSLS-1102-10-G2-103
31CELLLNCell 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
REFID
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
RowSTUDYIDDOMAINGTSEQGTREFID
Expand
titlegt.xpt (similar to LB)

cells growing in plate, treat cells in the plate, then add NRU dye, then extract NRU (the OBUID) dye and transfer to another plate (put in spectrophotometer & read).

  • row 161: This shows the EC50 result value for the entire assay (the SETCD, EUID, and OBUID are null).
RowSTUDYIDASSAYIDDOMAINGTSEQ
GTTESTCDGTTESTGTORRESGTORRESUGTCOLSRT
(coll. summ. result type)
GTSTRESCGTSTRESNGTSTRESU
1123
NRU
GT11-3-BABSORBAbsorbance Reading1.7
(0.0 - 2.0)


1.71.7
2123
NRU
GT21-3-BBKCABSBackground Corrected Absorbance Reading

1.6



1.61.6
3123
NRU
GT31-3-BRELABSRelative Absorbance Reading77.7
%


77.777.7
%

4123
NRU
GT41-3-CABSORBAbsorbance Reading1.8
(0.0 - 2.0)


1.81.8
5123GT51-3-CBKCABSBackground Corrected Absorbance Reading

1.7



1.71.7
6123
NRU
GT61-3-CRELABSRelative Absorbance Reading77.4

77.477.4
7123
NRU
GT71-3RELABSRelative Absorbance
Reading 
Reading78.2%MEAN78.278.2%
8123GT81-3RELABSRelative Absorbance
Reading 
Reading2.9%STANDARD DEVIATION2.92.9%
9123GT91-3RELABSRelative Absorbance
Reading 
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

80

12123
NRU
GT
11
121-10-GRELABSRelative Absorbance Reading8.57

8.578.
5712
57
13123GT131-10RELABSRelative Absorbance Reading

8.94

%MEAN

8.94

8.94

13


14123GT141-10RELABSRelative Absorbance Reading

2.72

%

STANDARD DEVIATION

2.72

2.72

...

15123GT15
14
1-10RELABSRelative Absorbance Reading

30.5


COEFFICIENT OF VARIANCE

30.5

30.5

15

16123GT162-10-GABSORBAbsorbance Reading0.9
16





17123GT172-10-GBKCABSBackground Corrected Absorbance Reading

0.8

160





18123
NRU
GT
17
182-10-GRELABSRelative Absorbance Reading6.30

6.306.30
19123
NRU
GT
18
192-10RELABSRelative Absorbance Reading

5.91

%MEAN

5.91

5.91


20123
NRU
GT
19
202-10RELABSRelative Absorbance Reading

0.83

%

STANDARD DEVIATION

0.83

0.83


21123
NRU
GT
20
212-10RELABSRelative Absorbance Reading

14.1


COEFFICIENT OF VARIANCE

14.1

14.1

161

22123
NRU
GT
21
22123NRU
EC50

EC50CYTX

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