This is an example showing the report table, trial design, and results from a study's in vitro bacterial reverse mutation test using 4 different amino acid-requiring strains of S. typhimurium and 1 strain of E. coli to detect point mutations. TOBA-129
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Getting issue details...STATUS
In this example, the Trial Summary (TS) dataset,TOBA-368
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Getting issue details...STATUS includes many informational fieldsTOBA-369
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Getting issue details...STATUS that may provide context at the study level. TSGRPID is used to link records (name, location, country) related to the test facility (TSGRPID = 1) and records related to the test site (TSGRPID = 2). The study director is associated with the test facility and the principal investigator is associated with the test site. The primary treatment CAS registry number is not known; this is recorded as an empty TSVAL and "UNKNOWN" in the corresponding TSVALNF.
This table shows the assay results for study 8325064, test article TA1, and 3 strains of salmonella (TA98, TA100, and TA1535) at varying concentrations. For ease of reference, each row has been labeled in the right-hand margin with the applicant-defined trial set label (e.g., SetA). For brevity, the remaining tables (e.g., additional strains, samples prepared without metabolic activation) are not included.
Rows 1-2:
Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records,TOBA-366
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since both GLP types apply for this 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=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER). TOBA-56
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Rows 18-26:TOBA-367
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Show that this study includes 2 different species of bacteria and a total of 5 strains.
Rows 18-23:
Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with 4 different strains that are tested in this study.
Rows 24-26:
Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain that is tested in this study.
Row Captions Debug Message
Please move all content other than the row caption labels out of the first column of the table.
ts.xpt
xx.xpt
Row
STUDYID
GNTXAID
DOMAIN
TSSEQ
TSGRPID
TSPARMCD
TSPARM
TSVAL
TSVALNF
1
8325064
Ames
TS
1
GLPTYP
Good Laboratory Practice Type
FDA
2
8325064
Ames
TS
2
GLPTYP
Good Laboratory Practice Type
OECD
3
8325064
Ames
TS
1
STSTDTC
Study Start Date
2015-07-29
4
8325064
Ames
TS
1
STITLE
Study Title
The Bacterial Reverse Mutation Test, Study 8325064-1
5
8325064
Ames
TS
1
SNDIGVER
SEND Implementation Guide Version
TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6
8325064
Ames
TS
1
SNDCTVER
SEND Controlled Terminology Version
SEND Terminology 2021-09-30
7
8325064
Ames
TS
1
SAPPLCNT
Applicant Organization
Example Applicant Inc.
8
8325064
Ames
TS
1
SPREFID
Applicant's Study Reference ID
NOT APPLICABLE
9
8325064
Ames
TS
1
1
TSTFNAM
Test Facility Name
Example Tox Lab Name
10
8325064
Ames
TS
1
1
TSTFLOC
Test Facility Location
10 Somewhere Street, Montgomery, AL 10000
11
8325064
Ames
TS
1
1
TFCNTRY
Test Facility Country
USA
12
8325064
Ames
TS
1
1
STDIR
Study Director
Dr. R. Smith
13
8325064
Ames
TS
1
GLPFL
GLP Flag
N
14
8325064
Ames
TS
1
4
TSTGDNAM
Testing Guideline Name
Test NO. 471
15
8325064
Ames
TS
1
4
TSTGDORG
Testing Guideline Organization
OECD
16
8325064
Ames
TS
1
4
TSTGDVER
Testing Guideline Version
2020-06-29
17
8325064
Ames
TS
1
SSTYP
Study Type
GENOTOXICITY IN VITRO
18
8325064
Ames
TS
1
SSSTYP
Study Sub Type
BACTERIAL REVERSE MUTATION TEST
19
8325064
Ames
TS
1
2
SPECIES
Species
SALMONELLA TYPHIMURIUM TOBA-123
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20
8325064
Ames
TS
1
2
STRAIN
Strain/Substrain
TA98
21
8325064
Ames
TS
1
2
STRAIN
Strain/Substrain
TA100
22
8325064
Ames
TS
1
2
STRAIN
Strain/Substrain
TA1535
23
8325064
Ames
TS
1
2
STRAIN
Strain/Substrain
TA1537
24
8325064
Ames
TS
1
2
CELLLN
Cell Line
25
8325064
Ames
TS
1
3
SPECIES
Species
Escherichia coli
26
8325064
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TS
1
3
STRAIN
Strain/Substrain
WP2 uvrA pKM101
27
8325064
Ames
TS
1
3
CELLLN
Cell Line
Dataset Debug Message
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This example Trial Set (TX) dataset shows information about the test conditions for SetA and SetR in this study. For brevity, the dataset does not show information for SetF, SetG, or any other sets. A fully formed TX dataset for this example study would include information about the test conditions for all sets.
Rows 1-14:
Show trial set SetSTM, with trial set parameters and trial set values that comprise the test conditions for all data for the species S. typhimurium.
Rows 15, 24, 33, 42:
Show that SetA, SetF, SetG, and SetR each have a parent set code of SetSTM. As a child set of SetSTM, each of these sets inherit the test conditions of SetSTM.
Rows 16-23:
Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the data for the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064.
Rows 25-32:
Show trial set parameters and trial set values that comprise the test conditions for the set SetF. SetF is the data for the strain of TA98 with a concentration value of 500 µg/plate. SetF is associated with the sixth row, labeled "SetF", in the report table for example study 8325064.
Rows 33-41:
Show trial set parameters and trial set values that comprise the test conditions for the set SetG. SetG is the data for the strain of TA98 with a concentration value of 1600 µg/plate. SetG is associated with the seventh row, labeled "SetG", in the report table for example study 8325064.
Rows 42-50:
Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the strain of TA100, positive control with a concentration value of 2 µg/plate. SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
Row 10:
SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID, in this case CIG01a, matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2, Product Design Parameters and Conformance Testing, Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a.
SPDEVID is the applicant-defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset (see also Section 2.8.9.7, SEND Device Identifiers (DI)). The value of SPDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1.
Row 14:
Shows a value for DUREFID. DUREFID serves as a link to the Device-In Use Properties (DU) domain (see also Section 2.8.9.8, SEND Device-In-Use (DU)), where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine, as in the DU dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 2.
tx.xpt
tx.xpt
Row
STUDYID
GNTXAID
DOMAIN
SETCD
SET
TXSEQ
TXPARMCD
TXPARM
TXVAL
1
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
1
SPECIES
Species
SALMONELLA TYPHIMURIUM
2
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
2
TRTDMIN
In vitro Treatment Duration Minimum
71.5
3
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
3
TRTDTRG
In vitro Treatment Duration Target
72
4
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
4
TRTDMAX
In vitro Treatment Duration Maximum
72.5
5
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
5
TRTDU
In vitro Treatment Duration Unit
HOURS
6
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
6
INCBTMP
Incubation Temperature
37
7
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
7
INCBTMPU
Incubation Temperature Unit
C
8
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
8
HUMID
Atmospheric Relative Humidity Percent
50
9
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
9
ATMCO2
Atmospheric CO2 Percent
5
10
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
10
SPTOBID
Applicant-defined tobacco identifier
CIG01a
11
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
11
EXPTYP
Exposure Type
Submerged
12
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
12
SAMTYP
Sample Type
Total Particulate Matter in PBS
13
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
13
SPDEVID
Applicant-defined device identifier
PUFFMASTER3K
14
8325064
Ames
TX
SetSTM
SALMONELLA TYPHIMURIUM
14
DUREFID
Smoke Regimen
NON-INTENSE REGIMEN
15
8325064
Ames
TX
SetA
A-TA98-C0
15
PSETCD
Parent Set Code
SetSTM
16
8325064
Ames
TX
SetA
A-TA98-C0
15
STRAIN
Strain/Substrain
TA98
17
8325064
Ames
TX
SetA
A-TA98-C0
16
METACT
Metabolic Activation
NOT APPLICABLE
18
8325064
Ames
TX
SetA
A-TA98-C0
17
METACTFL
Y/N presence of metabolic activation
N
19
8325064
Ames
TX
SetA
A-TA98-C0
18
INTRVN
Name of the intervention article
TA1
20
8325064
Ames
TX
SetA
A-TA98-C0
19
ITVTYPE
Type of intervention article
Vehicle Control
21
8325064
Ames
TX
SetA
A-TA98-C0
20
ITVCONC
Concentration of intervention article
0
22
8325064
Ames
TX
SetA
A-TA98-C0
21
ITVCONCU
Concentration Unit
ug/plate
23
8325064
Ames
TX
SetA
A-TA98-C0
22
TRTV
Treatment Vehicle
DMSO
24
8325064
Ames
TX
SetF
F-TA98-C500
PSETCD
Parent Set Code
SetSTM
25
8325064
Ames
TX
SetF
F-TA98-C500
23
STRAIN
Strain/Substrain
TA98
26
8325064
Ames
TX
SetF
F-TA98-C500
24
METACT
Metabolic Activation
NOT APPLICABLE
27
8325064
Ames
TX
SetF
F-TA98-C500
25
METACTFL
Y/N presence of metabolic activation
N
28
8325064
Ames
TX
SetF
F-TA98-C500
26
INTRVN
Name of the intervention article
TA1
29
8325064
Ames
TX
SetF
F-TA98-C500
27
ITVTYPE
Type of intervention article
Product
30
8325064
Ames
TX
SetF
F-TA98-C500
28
ITVCONC
Concentration of intervention article
500
31
8325064
Ames
TX
SetF
F-TA98-C500
29
ITVCONCU
Concentration Unit
ug/plate
32
8325064
Ames
TX
SetF
F-TA98-C500
30
TRTV
Treatment Vehicle
DMSO
33
8325064
Ames
TX
SetG
G-TA98-C1600
31
PSETCD
Parent Set Code
SetSTM
34
8325064
Ames
TX
SetG
G-TA98-C1600
31
STRAIN
Strain/Substrain
TA98
35
8325064
Ames
TX
SetG
G-TA98-C1600
32
METACT
Metabolic Activation
NOT APPLICABLE
36
8325064
Ames
TX
SetG
G-TA98-C1600
33
METACTFL
Y/N presence of metabolic activation
N
37
8325064
Ames
TX
SetG
G-TA98-C1600
34
INTRVN
Name of the intervention article
TA1
38
8325064
Ames
TX
SetG
G-TA98-C1600
35
ITVTYPE
Type of intervention article
Product
39
8325064
Ames
TX
SetG
G-TA98-C1600
36
ITVCONC
Concentration of intervention article
1600
40
8325064
Ames
TX
SetG
G-TA98-C1600
37
ITVCONCU
Concentration Unit
ug/plate
41
8325064
Ames
TX
SetG
G-TA98-C1600
38
TRTV
Treatment Vehicle
DMSO
42
8325064
Ames
TX
SetR
R-TA100-C2
39
PSETCD
Parent Set Code
SetSTM
43
8325064
Ames
TX
SetR
R-TA100-C2
39
STRAIN
Strain/Substrain
TA100
44
8325064
Ames
TX
SetR
R-TA100-C2
40
METACT
Metabolic Activation
NOT APPLICABLE
45
8325064
Ames
TX
SetR
R-TA100-C2
41
METACTFL
Y/N presence of metabolic activation
N
46
8325064
Ames
TX
SetR
R-TA100-C2
42
INTRVN
name of the intervention article
NaN3
47
8325064
Ames
TX
SetR
R-TA100-C2
43
ITVTYPE
type of intervention article
Positive Control
48
8325064
Ames
TX
SetR
R-TA100-C2
44
ITVCONC
Concentration of intervention article
2
49
8325064
Ames
TX
SetR
R-TA100-C2
45
ITVCONCU
Concentration Unit
ug/plate
50
8325064
Ames
TX
SetR
R-TA100-C2
46
TRTV
Treatment Vehicle
DMSO
$warningHtml
Dataset Wrapper Debug Message
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REFID values are defined by the applicant to uniquely identify the observational unit within an experimental unit. In the simplified diagram of an assay procedure (below), the test tube that contains the possible mutagen is an example of an entity that would have a REFID indicating information at the level of trial set. The petri plate created from that test tube and used to count revertant numbers is an example of an entity that would be at an observational level.
This picture does not depict the more complicated procedures, TOBA-370
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Getting issue details...STATUStrial sets, or observational units for the example study. For study 8325064, the applicant chose to define the REFIDs at the trial set level with a single character (e.g., A, F, G, R) and chose to define REFIDs at the observational level based on the location of each tube in 1 of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).
Row 1:
Shows the value of REFID=STM. This REFID refers to the trial set with a SETCD of "SetSTM"TOBA-489
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, as defined in the TX dataset. LEVEL=1 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 1, 2, 8, 12, 16:
Show that the trial set SetSTM is the parent of set codes SetA, SetF, SetG, and SetR.
Row 2:
Shows the value of REFID=A. This REFID refers to the trial set with a SETCD of "SetA", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 3-7:
Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A.
Row 8:
Shows the value of REFID=F. This REFID refers to the trial set with a SETCD of "SetF", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 9-11:
Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F.
Row 12:
Shows the value of REFID=G. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 13-15:
Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G.
Row 16:
Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 17-19:
Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R.
Show the number of revertant colonies per plate collected for each of 5 observational units, GTREFID=1_1 through 1_5 (see description in the RELREF dataset).
Rows 6, 7:
Show summary values collected (mean, standard deviation) for GTREFID=A that apply to the entire trial set, SetA, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID as shown in the RELREF dataset.
Rows 8-13:
Revertent colonies were counted for each of 3 plates/observational units (GTREFID=6_1 through 6_3) and each value is associated with a record to show a postfix code of "V" (Very thin background bacterial lawn).
Rows 14-16:
Show summary values collected (mean, standard deviation, fold increase) for GTREFID=F that apply to the entire trial set, SetF, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset.
Rows 17-19:
Show 3 plates/observational units (GTREFID=5_1 through 5_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T".
Rows 20-22:
Show the number of revertant colonies per plate collected for each of 3 observational units (GTREFID=18_1 through 18_3).
Rows 23-25:
Show summary values collected (mean, standard deviation, fold increase) for GTREFID=R that apply to the entire trial set, SetR, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset.