This example shows a sample report table, trial design, and results dataset for study 123 for the determination of the in vitro genotoxicity potential of tobacco products using the in vitro micronucleus assay.
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 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=2) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER). TOBA-56
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ts.xpt
xx.xpt
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
SAPPLCNT
Applicant OrganizationTOBA-356
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Example Applicant, Inc.
8
123
NRU
TS
1
SPREFID
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
2
TSTGDNAM
Testing Guideline Name
GUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15
123
NRU
TS
1
2
TSTGDORG
Testing Guideline Organization
OECD
16
123
NRU
TS
1
2
TSTGDVER
Testing Guideline Version
29-July-2016
17
123
NRU
TS
1
SSTYP
Study Type
GENOTOXICITY IN VITRO
18
123
NRU
TS
1
SSSTYP
Study Sub Type
MICRONUCLEUS TEST
19
123
NRU
TS
1
SPECIES
Species
HUMAN
20
123
NRU
TS
1
CELLLN
Cell Line
TK6 LYMPHOBLASTOID
Dataset Debug Message
When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
This example Trial Sets dataset shows information about the test conditions for set A1 and A2 in this example study. Sets A1 and A2 can be seen in the first and second rows respectively of the sample report Table 1 (above). For brevity, the TX dataset and the findings (GT) dataset do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets. TOBA-457
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Getting issue details...STATUS
Rows 1-17:
Show the experimental parameters that are common for table 1 of study 123.
Rows 18, 25:
Show that sets A1 and A2 each have a parent set code of A. As a child of set A, each of these sets inherit the test conditions of set A.
Rows 18-24:
Show trial set parameters and values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short-term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0".
Set A1 is associated with the first row in the sample report table for study 123.
Rows 25-31:
Show trial set parameters and values that comprise the test conditions for trial set A2. Set A2 is the data for the short-term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250".
Set A2 is associated with the second row in the sample report table for study 123.
tx.xpt
tx.xpt
Row
STUDYID
GNTXAID
DOMAIN
SETCD
SET
TXSEQ
TXPARMCD
TXPARM
TXVAL
1
123
MNvit
TX
A
ST+S9
1
METACT
Metabolic Activation
+S9
2
123
MNvit
TX
A
ST+S9
2
METACTFL
Y/N presence of metabolic activation
Y
3
123
MNvit
TX
A
ST+S9
3
TRTDMIN
In vitro Treatment Duration Minimum
3
4
123
MNvit
TX
A
ST+S9
4
TRTDTRG
In vitro Treatment Duration Target
3.5
5
123
MNvit
TX
A
ST+S9
5
TRTDMAX
In vitro Treatment Duration Maximum
4
6
123
MNvit
TX
A
ST+S9
6
TRTDU
In vitro Treatment Duration Unit
HOURS
7
123
MNvit
TX
A
ST+S9
7
RCVDMIN
Recovery Duration Minimum
23.5
8
123
MNvit
TX
A
ST+S9
8
RCVDTRG
Recovery Duration Target
24
9
123
MNvit
TX
A
ST+S9
9
RCVDMAX
Recovery Duration Maximum
24.5
10
123
MNvit
TX
A
ST+S9
10
RCVDU
Recovery Duration Unit
HOURS
11
123
MNvit
TX
A
ST+S9
11
INCBTMP
Incubation Temperature
37
12
123
MNvit
TX
A
ST+S9
12
INCBTMPU
Incubation Temperature Unit
C
13
123
MNvit
TX
A
ST+S9
13
HUMID
Atmospheric Relative Humidity Percent
50
14
123
MNvit
TX
A
ST+S9
14
ATMCO2
Atmospheric CO2 Percent
5
15
123
MNvit
TX
A
ST+S9
15
SPTOBID
Applicant-defined tobacco identifier
CIG01a
16
123
MNvit
TX
A
ST+S9
16
EXPTYP
Exposure Type
Submerged
17
123
MNvit
TX
A
ST+S9
17
SAMTYP
Sample Type
Total Particulate Matter in DMSO
18
123
MNvit
TX
A1
ST+S9_C0
1
PSETCD
Parent Set Code
A
19
123
MNvit
TX
A1
ST+S9_CO
2
INTRVN
Name of the Intervention Article
Tobacco ProdA
20
123
MNvit
TX
A1
ST+S9_C0
3
ITVTYPE
type of intervention article
Negative Control
21
123
MNvit
TX
A1
ST+S9_C0
4
ITVCONC
Concentration of intervention article
0
22
123
MNvit
TX
A1
ST+S9_C0
5
ITVCONCU
Concentration Unit
ug/ml
23
123
MNvit
TX
A1
ST+S9_C0
6
SPDEVID
Applicant-defined device identifier
PUFFMASTER3K
24
123
MNvit
TX
A1
ST+S9_C0
7
DUREFID
Smoke Regimen
Medium Intensity Regimen
25
123
MNvit
TX
A2
ST+S9_C1250
1
PSETCD
Parent Set Code
A
26
123
MNvit
TX
A2
ST+S9_C1250
2
INTRVN
Name of the Intervention Article
Tobacco ProdA
27
123
MNvit
TX
A2
ST+S9_C1250
3
ITVTYPE
type of intervention article
Product
28
123
MNvit
TX
A2
ST+S9_C1250
4
ITVCONC
Concentration of intervention article
1250
29
123
MNvit
TX
A2
ST+S9_C1250
5
ITVCONCU
Concentration Unit
ug/ml
30
123
MNvit
TX
A2
ST+S9_C1250
6
SPDEVID
Applicant-defined device identifier
PUFFMASTER2023
31
123
MNvit
TX
A2
ST+S9_C1250
7
DUREFID
Smoke Regimen
High Intensity Regimen
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Row 1:
Shows the value of REFID=C0. This REFID refers to the trial set with a SETCD of "A1", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.
Rows 2-5:
Show the values of 4 observational units (C0_Count1 through C0_Count4) that are within the parent experimental unit, REFID=C0. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.
Row 6:
Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of "A2", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.
Rows 7-10:
Show the values of 4 observational units (C1250_Count1 through C1250_Count4) TOBA-687
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that are within the parent experimental unit, REFID=C0. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.
$titleHtml
relref.xpt
Row
STUDYID
GNTXAID
SETCD
REFID
PARENT
LEVEL
LVLDESC
1
123
MNvit
A1TOBA-643
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C0
1
EXPERIMENTAL UNIT/TRIAL SET
2
123
MNvit
A1
C0-Count1
C0
2
OBSERVATIONAL UNIT
3
123
MNvit
A1
C0-Count2
C0
2
OBSERVATIONAL UNIT
4
123
MNvit
A1
C0-Count3
C0
2
OBSERVATIONAL UNIT
5
123
MNvit
A1
C0-Count4
C0
2
OBSERVATIONAL UNIT
6
123
MNvit
A2
C1250
1
EXPERIMENTAL UNIT/TRIAL SET
7
123
MNvit
A2
C1250-Count1
C1250
2
OBSERVATIONAL UNIT
8
123
MNvit
A2
C1250-Count2
C1250
2
OBSERVATIONAL UNIT
9
123
MNvit
A2
C1250-Count3
C1250
2
OBSERVATIONAL UNIT
10
123
MNvit
A2
C1250-Count4
C1250
2
OBSERVATIONAL UNIT
Dataset Debug Message
When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Rows 1-3, 8:
Show percentage result values that apply to GTREFID=C0. REFID=C0, as shown in the RELREF dataset, relates this data to the trial set in the first row of table 1 in the sample report table for study 123.
Rows 4-7:
Show the 4 micronucleated cell counts for the observational units with GTREFID from C0-Count1 through C0-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.
Rows 9-11, 16:
Show percentage result values that apply to GTREFID=C1250. REFID=C1250, as shown in the RELREF dataset, relates this data to the trial set in the second row of table 1 in the sample report table for study 123.
Rows 12-15:
Show the 4 micronucleated cell counts for the observational units with GTREFID from C1250-Count1 through C1250-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.
