Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this example study.
Row 8:
Shows that the applicant's
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-356
study reference ID is not applicable.
Rows 9-12:
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).
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-56
Dataset2
Row
STUDYID
GNTXAID
DOMAIN
TSSEQ
TSGRPID
TSPARMCD
TSPARM
TSVAL
TSVALNF
1
123
NRU
TS
1
GLPTYP
Good Laboratory Practice Type
FDA
2
123
NRU
TS
2
GLPTYP
Good Laboratory Practice Type
OECD
3
123
NRU
TS
1
STSTDTC
Study Start Date
2022-05-25
4
123
NRU
TS
1
STITLE
Study Title
Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay
5
123
NRU
TS
1
SNDIGVER
SEND Implementation Guide Version
TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6
123
NRU
TS
1
SNDCTVER
SEND Controlled Terminology Version
SEND Terminology 2021-09-30
7
123
NRU
TS
1
APPLCNT
Applicant Organization
Example Applicant Inc.
8
123
NRU
TS
1
APREFID
Applicant Study Reference ID
NOT APPLICABLE
9
123
NRU
TS
1
1
TSTFNAM
Test Facility Name
Example Test Lab Name
10
123
NRU
TS
1
1
TSTFLOC
Test Facility Location
10 Somewhere Street, Montgomery, AL 10000
11
123
NRU
TS
1
1
TFCNTRY
Test Facility Country
USA
12
123
NRU
TS
1
1
STDIR
Study Director
Dr. R. Smith
13
123
NRU
TS
1
GLPFL
GLP Flag
Y
14
123
NRU
TS
1
4
TSTGDNAM
Testing Guideline Name
Publication No. 07-4519
15
123
NRU
TS
1
4
TSTGDORG
Testing Guideline Organization
NIH
16
123
NRU
TS
1
4
TSTGDVER
Testing Guideline Version
2006-11
17
123
NRU
TS
1
SSTYP
Study Type
GENOTOXICITY IN VITRO
18
123
NRU
TS
1
SSSTYP
Study Sub Type
IN VITRO NEUTRAL RED UPTAKE
GNTXAID
Genetic Toxicology Assay Identifier
NRU
19
123
NRU
TS
1
SPECIES
Species
HUMAN
20
123
NRU
TS
1
CELLLN
Cell Line
NHK
Dataset wrap
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-279
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 13-20:
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.
Row 20:
Shows the value for Cell Line (CELLLN) is not applicable because the well is a media-only well, having no NHK cells.
Rows 21-28:
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 29-36:
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
Row
STUDYID
GNTXAID
DOMAIN
SETCD
SET
TXSEQ
TXPARMCD
TXPARM
TXVAL
1
123
NRU
TX
NRU
NRU_ASSAY
1
IVTDMIN
In vitro Treatment Duration Minimum
47.5
2
123
NRU
TX
NRU
NRU_ASSAY
2
IVTDTRG
In vitro Treatment Duration Target
48
3
123
NRU
TX
NRU
NRU_ASSAY
3
IVTDMAX
In vitro Treatment Duration Maximum
48.5
4
123
NRU
TX
NRU
NRU_ASSAY
4
IVTDU
In vitro Treatment Duration Unit
HOURS
5
123
NRU
TX
NRU
NRU_ASSAY
5
INCBTMP
Incubation Temperature
37
6
123
NRU
TX
NRU
NRU_ASSAY
6
INCBTMPU
Incubation Temperature Unit
C
7
123
NRU
TX
NRU
NRU_ASSAY
7
SWAVENM
Spectrophotometer Wavelength
540
8
123
NRU
TX
NRU
NRU_ASSAY
8
ATMRHP
Atmospheric Relative Humidity Percent
90
9
123
NRU
TX
NRU
NRU_ASSAY
9
ATMCO2P
Atmospheric CO2 Percent
5
10
123
NRU
TX
NRU
NRU_ASSAY
10
SPDEVID
applicant defined device identifier
PUFFMASTER3k
11
123
NRU
TX
NRU
NRU_ASSAY
11
SMKRGM
Smoking Regimen
MEDIUM INTENSITY REGIMEN
12
123
NRU
TX
NRU
NRU_ASSAY
12
SPTOBID
Applicant-defined tobacco identifier
CIG01a
13
123
NRU
TX
CSC-50b
CSC-50-blank
13
PSETCD
Parent Set Code
NRU
14
123
NRU
TX
CSC-50b
CSC-50-blank
14
EXPTYP
Exposure Type
Air Liquid Interface
15
123
NRU
TX
CSC-50b
CSC-50-blank
15
SAMTYP
Sample Type
Whole Smoke Conditioned Media
16
123
NRU
TX
CSC-50b
CSC-50-blank
16
ITVNAM
Name of the Intervention Article
Tobacco ProdA
17
123
NRU
TX
CSC-50b
CSC-50-blank
17
ITVTYPE
Intervention Article Type
PRODUCT
18
123
NRU
TX
CSC-50b
CSC-50-blank
18
ITVCONC
Intervention Article Concentration
50
19
123
NRU
TX
CSC-50b
CSC-50-blank
19
ITVCONCU
Intervention Article Concentration Unit
ug/ml
20
123
NRU
TX
CSC-50b
CSC-50-blank
20
CELLLN
Cell Line
NOT APPLICABLE
21
123
NRU
TX
CSC-50
CSC-50
21
PSETCD
Parent Set Code
NRU
22
123
NRU
TX
CSC-50
CSC-50
22
EXPTYP
Exposure Type
Air Liquid Interface
23
123
NRU
TX
CSC-50
CSC-50
23
SAMTYP
Sample Type
Whole Smoke Conditioned Media
24
123
NRU
TX
CSC-50
CSC-50
24
ITVNAM
Intervention Article Name
Tobacco ProdA
25
123
NRU
TX
CSC-50
CSC-50
25
ITVTYPE
Intervention Article Type
PRODUCT
26
123
NRU
TX
CSC-50
CSC-50
26
ITVCONC
Intervention Article Concentration
50
27
123
NRU
TX
CSC-50
CSC-50
27
ITVCONCU
Intervention Article Concentration Unit
ug/ml
28
123
NRU
TX
CSC-50
CSC-50
28
CELLLN
Cell Line
NHK
29
123
NRU
TX
SLS-110
SLS-110
29
PSETCD
Parent Set Code
NRU
30
123
NRU
TX
SLS-110
SLS-110
30
EXPTYP
Exposure Type
Air Liquid Interface
31
123
NRU
TX
SLS-110
SLS-110
31
SAMTYP
Sample Type
Liquid
32
123
NRU
TX
SLS-110
SLS-110
32
ITVNAM
Intervention Article Name
Sodium Laurel Sulfate
33
123
NRU
TX
SLS-110
SLS-110
33
ITVTYPE
Intervention Article Type
POSITIVE CONTROL
34
123
NRU
TX
SLS-110
SLS-110
34
ITVCONC
Intervention Article Concentration
110
35
123
NRU
TX
SLS-110
SLS-110
35
ITVCONCU
Intervention Article Concentration Unit
ug/ml
36
123
NRU
TX
SLS-110
SLS-110
36
CELLLN
Cell Line
NHK
Dataset wrap
Name
relref
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-280
Rowcaps
Row 1:
Shows the REFID of 123NRU that indicates the entire assay.
Rows 2, 5, 8, 9:
Show the REFIDs at the second level, all within the parent assay of 123NRU (REFID values of 1-3b, 1-3, 1-10, 2-10) which have LVLDESC of OBSERVATIONAL UNIT. 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 3-4, 6-7, 10-11:
Show REFID values that the applicant chose, in this case, to represent the plate number (1 or 2), column (1 - 12), and row (A-G) of the 96-well plates.
Rows 3-4:
Show the REFIDs 1-3-A and 1-3-H that indicate two experimental units within the parent trial set of 1-3b.
Rows 6-7:
Show the REFIDs 1-3-B and 1-3-C that indicate two experimental units within the parent trial set of 1-3.
Row 10:
Shows the REFID of 1-10-G that indicates the experimental unit within the parent trial set of 1-10.
Row 11:
Shows the REFID of 2-10-G that indicates the experimental unit within the parent trial set of 2-10.
Dataset2
tableid
relref
Row
STUDYID
GNTXAID
SETCD
REFID
PARENT
LEVEL
LVLDESC
1
123
NRU
NRU
123NRU
1
ASSAY
2
123
NRU
CSC-50b
1-3b
123NRU
2
OBERVATIONAL UNIT
3
123
NRU
CSC-50b
1-3-A
1-3b
3
EXPERIMENTAL UNIT
4
123
NRU
CSC-50b
1-3-H
1-3b
3
EXPERIMENTAL UNIT
5
123
NRU
CSC-50
1-3
123NRU
2
OBERVATIONAL UNIT
6
123
NRU
CSC-50
1-3-B
1-3
3
EXPERIMENTAL UNIT
7
123
NRU
CSC-50
1-3-C
1-3
3
EXPERIMENTAL UNIT
8
123
NRU
SLS-110
1-10
123NRU
2
OBERVATIONAL UNIT
9
123
NRU
SLS-110
2-10
123NRU
2
OBERVATIONAL UNIT
10
123
NRU
SLS-110
1-10-G
1-10
3
EXPERIMENTAL UNIT
11
123
NRU
SLS-110
2-10-G
2-10
3
EXPERIMENTAL UNIT
Dataset wrap
Name
gt
Rowcaps
Rows 1-3:
Show the experimental unit data for GTREFID 1-3-B.
Rows 1-2, 4-5, 10-11, 16-17:
These data (absorbance reading and background absorbance reading) are not shown in the sample report table above but included here for completeness of the NRU assay.
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.
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-592
Dataset2
Row
STUDYID
GNTXAID
DOMAIN
GTSEQ
GTREFID
GTTESTCD
GTTEST
GTORRES
GTORRESU
GTCOLSRT
GTSTRESC
GTSTRESN
GTSTRESU
1
123
NRU
GT
1
1-3-B
ABSORB
Absorbance Reading
1.7
1.7
1.7
2
123
NRU
GT
2
1-3-B
BKCABS
Background Corrected Absorbance Reading
1.6
1.6
1.6
3
123
NRU
GT
3
1-3-B
RELABS
Relative Absorbance Reading
77.7
%
77.7
77.7
%
4
123
NRU
GT
4
1-3-C
ABSORB
Absorbance Reading
1.8
1.8
1.8
5
123
NRU
GT
5
1-3-C
BKCABS
Background Corrected Absorbance Reading
1.7
1.7
1.7
6
123
NRU
GT
6
1-3-C
RELABS
Relative Absorbance Reading
77.4
77.4
77.4
7
123
NRU
GT
7
1-3
RELABS
Relative Absorbance Reading
78.2
%
MEAN
78.2
78.2
%
8
123
NRU
GT
8
1-3
RELABS
Relative Absorbance Reading
2.9
%
STANDARD DEVIATION
2.9
2.9
%
9
123
NRU
GT
9
1-3
RELABS
Relative Absorbance Reading
3.6
COEFFICIENT OF VARIANCE
3.6
3.6
10
123
NRU
GT
10
1-10-G
ABSORB
Absorbance Reading
0.7
0.7
0.7
11
123
NRU
GT
11
1-10-G
BKCABS
Background Corrected Absorbance Reading
0.6
0.6
0.6
12
123
NRU
GT
12
1-10-G
RELABS
Relative Absorbance Reading
8.57
8.57
8.57
13
123
NRU
GT
13
1-10
RELABS
Relative Absorbance Reading
8.94
%
MEAN
8.94
8.94
14
123
NRU
GT
14
1-10
RELABS
Relative Absorbance Reading
2.72
%
STANDARD DEVIATION
2.72
2.72
15
123
NRU
GT
15
1-10
RELABS
Relative Absorbance Reading
30.5
COEFFICIENT OF VARIANCE
30.5
30.5
16
123
NRU
GT
16
2-10-G
ABSORB
Absorbance Reading
0.9
17
123
NRU
GT
17
2-10-G
BKCABS
Background Corrected Absorbance Reading
0.8
18
123
NRU
GT
18
2-10-G
RELABS
Relative Absorbance Reading
6.30
6.30
6.30
19
123
NRU
GT
19
2-10
RELABS
Relative Absorbance Reading
5.91
%
MEAN
5.91
5.91
20
123
NRU
GT
20
2-10
RELABS
Relative Absorbance Reading
0.83
%
STANDARD DEVIATION
0.83
0.83
21
123
NRU
GT
21
2-10
RELABS
Relative Absorbance Reading
14.1
COEFFICIENT OF VARIANCE
14.1
14.1
22
123
NRU
GT
22
123NRU
EC50CYTX
Jira
showSummary
false
server
Issue Tracker (JIRA)
serverId
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key
TOBA-132
Effective Concentration of 50 Percent Cytotoxicity