Versions Compared

Old Version 184

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 is an example showing the report table, trial design, and results from a study's in vitro bacterial reverse mutation test

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-774
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-505
using 4 different amino acid-requiring strains of S. typhimurium and 1 strain of E. coli to detect point mutations. jira

Expand

...

showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-129

...

titleReport Table for Example Study 8325064

This table shows

Expand
titleReport Table for Example Study 8325064

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 For brevity, the remaining tables (e.g., additional strains, samples prepared without metabolic activation) are not included.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-506
For  For ease of reference in the table below, each row has been labeled in the right-hand margin with the applicant-defined trial set label (e.g., SetA).  For brevity, only the four bolded sets are represented in the following example datasets.


This example Trial Summary (TS) dataset

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-481
,
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-368
shows many informational fields
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-369
that provide context at the study level.   

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-663
 
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-664

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-367

...

, shows many informational fields that provide context at the study level.   

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  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 Bacterial Reverse Mutation Assay.
Rows 19-27:Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with the 4 different strains and cell lines that are tested in this  study.
Rows 28-30:

Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain and cell line that is tested in this study.

Dataset2
Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

18325064TS1
GLPTYPGood Laboratory Practice TypeFDA
28325064TS2
GLPTYPGood Laboratory Practice TypeOECD
38325064TS1
GLPFLGLP FlagN
48325064TS1
STSTDTCStudy Start Date2015-07-29
58325064TS1
STITLEStudy Title

The Bacterial Reverse Mutation Test, Study 8325064-1


68325064TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
78325064TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
88325064TS1
APPLCNTApplicantExample Applicant Inc.
98325064TS1
APREFIDApplicant's Study Reference ID
NOT APPLICABLE
108325064TS11TSTFNAMTest Facility NameExample Tox Lab Name
118325064TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
128325064TS11TFCNTRYTest Facility CountryUSA
138325064TS11STDIRStudy DirectorDr. R. Smith
148325064TS14TSTGDNAMTesting Guideline NameTest NO. 471
158325064TS14TSTGDORGTesting Guideline OrganizationOECD
168325064TS14TSTGDVERTesting Guideline Version2020-06-29
178325064TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
188325064TS1

GNTXAID

Genetic Toxicology Assay Identifier

AMES


198325064TS12

SPECIES

Species

SALMONELLA TYPHIMURIUM


208325064TS12STRAINStrain/SubstrainTA98
218325064TS22STRAINStrain/SubstrainTA100
228325064TS32STRAINStrain/SubstrainTA1535
238325064TS42STRAINStrain/SubstrainTA1537
248325064TS12CELLLNCell LineTA 98 hisD3052; rfa-; uvrB-
258325064TS22CELLLNCell LineTA 100 hisG46; rfa-; uvrB-
268325064TS32CELLLNCell LineTA 1535 hisG46; rfa-; uvrB-
278325064TS42CELLLNCell LineTA 1537 hisC3076; rfa-; uvrB-
288325064TS23SPECIESSpecies

ESCHERICHIA COLI


298325064TS53STRAINStrain/SubstrainWP2 uvrA pKM101
308325064TS53CELLLNCell LinetrpE uvrA

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. 

Note that there are three trial set parameters that link to other important datasets: SPTOBID, APDEVID, and SMKRGM. 

  • SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID (e.g., 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.  The TO domain is described in Section 2.8.8.1, Tobacco Product Identifiers and Descriptors (TO).
  • The value of APDEVID (e.g., PUFFMASTER3K) matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. 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)). This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1.
  • SMKRGM 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 SMKRGM 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.
Dataset wrap
Nametx
Rowcaps
Rows 1-22:

Show trial set parameters and trial set values that are the test conditions specific to set SetA which is 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 23-44:

Show trial set parameters and trial set values that comprise the test conditions for the set SetF which is 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 45-66:Show trial set parameters and trial set values that comprise the test conditions for the set SetG which is 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 67-88:Show trial set parameters and trial set values that comprise the test conditions for the set SetR which is 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.
Dataset2

 

...

Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records,

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-366
since both GLP types apply for this  study. 

...

Show that TSGRPID (TSGRPID=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).  

Jira
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-56

...

Row 17:

...

Row 18:

...

Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain and cell line that is tested in this study.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-665

...

STUDYID

...

DOMAIN

...

TSSEQ

...

TSGRPID

...

TSPARMCD

...

TSPARM

...

TSVAL

...

TSVALNF

...

The Bacterial Reverse Mutation Test, Study 8325064-1

...

GNTXAID

...

AMES

...

SPECIES

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-484

...

SALMONELLA TYPHIMURIUM

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-123

...

ESCHERICHIA COLI

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-482

...

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. 

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-483
A fully formed TX dataset for this example study would include information about the test conditions for all sets. 

Dataset wrap
Nametx
Rowcaps
Rows 1-14:Show trial conditions that are common to all trial sets with the species S. typhimurium.  Similar rows are present in each of the trial sets.
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.

The TO domain is described in Section 2.8.8.1, Tobacco Product Identifiers and Descriptors (TO).

Row 13:

The value of APDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. 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)). 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 SMKRGM. SMKRGM 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 SMKRGM 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.

Rows 1-22:

Show trial set parameters and trial set values that are the test conditions specific to set SetA which is 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.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-666

Rows 23-44:

Show trial set parameters and trial set values that comprise the test conditions for the set SetF which is 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.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-667

Rows 45-66:Show trial set parameters and trial set values that comprise the test conditions for the set SetG which is 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 67-88:Show trial set parameters and trial set values that comprise the test conditions for the set SetR which is 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.
Dataset2

 

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1
RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064TXSetAA-TA98-C01SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064TXSetAA-TA98-C02IVTDMINIn vitro Treatment Duration Minimum71.5
38325064TX

SetA

A-TA98-C03IVTDTRGIn vitro Treatment Duration Target72
48325064TX

SetA

A-TA98-C04IVTDMAXIn vitro Treatment Duration Maximum72.5
58325064TXSetAA-TA98-C05IVTDUIn vitro Treatment Duration UnitHOURS
68325064TXSetAA-TA98-C06INCBTMPIncubation Temperature37
78325064TXSetAA-TA98-C07INCBTMPUIncubation Temperature UnitC
88325064TXSetAA-TA98-C08ATMRHPAtmospheric Relative Humidity Percent50
98325064TXSetAA-TA98-C09ATMCO2PAtmospheric CO2 Percent5
10
8325064TXSetAA-TA98-C0
1
10
SPECIESSpeciesSALMONELLA TYPHIMURIUM
SPTOBID

Applicant-defined tobacco identifier

CIG01a
11
2
8325064TXSetAA-TA98-C0
2
11
IVTDMINIn vitro Treatment Duration Minimum71.5
EXPTYP

Exposure Type

Submerged
12
3
8325064TX

SetA

A-TA98-C0
3
12
IVTDTRGIn vitro Treatment Duration Target72
SAMTYP

Sample Type

Total Particulate Matter in PBS
13
4
8325064TX

SetA

A-TA98-C0
4
13
IVTDMAXIn vitro Treatment Duration Maximum72.5
APDEVIDApplicant-defined device identifierPUFFMASTER3K
14
5
8325064TXSetAA-TA98-C0
5
14
IVTDUIn vitro Treatment Duration UnitHOURS
SMKRGMSmoking RegimenNON-INTENSE REGIMEN
15
6
8325064TXSetAA-TA98-C0
6
15
INCBTMPIncubation Temperature37
STRAINStrain/SubstrainTA98
16
7
8325064TXSetAA-TA98-C0
7
16
INCBTMPUIncubation Temperature UnitC
MTACTINDMetabolic Activating Agent NameNOT APPLICABLE
17
8
8325064TXSetAA-TA98-C0
8
17
ATMRHPAtmospheric Relative Humidity Percent50
METACTFLPresence of Metabolic Activation FlagN
18
9
8325064TXSetAA-TA98-C0
9
18
ATMCO2PAtmospheric CO2 Percent5
ITVNAM

Intervention Article Name

DMSO
19
10
8325064TXSetAA-TA98-C0
10
19
SPTOBID

Applicant-defined tobacco identifier

CIG01a
ITVTYPE

Intervention Article Type

VEHICLE
20
11
8325064TXSetAA-TA98-C0
11
20
EXPTYP

Exposure Type

Submerged
ITVCONCIntervention Article Concentration100
21
12
8325064TXSetAA-TA98-C0
12
21
SAMTYP

Sample Type

Total Particulate Matter in PBS
ITVCONCUIntervention Article Concentration Unit%
22
13
8325064TXSetAA-TA98-C0
13
22
APDEVIDApplicant-defined device identifierPUFFMASTER3K
TRTVTreatment VehicleDMSO
23
14
8325064TX
SetA
SetF
A
F-TA98-
C0
C500
14
23
SMKRGM
SPECIES
Smoking RegimenNON-INTENSE REGIMEN
SpeciesSALMONELLA TYPHIMURIUM
24
15
8325064TX
SetA
SetF
A
F-TA98-
C0
C500
15
24
STRAINStrain/SubstrainTA98
IVTDMINIn vitro Treatment Duration Minimum71.5
25
16
8325064TX
SetA
SetF
A
F-TA98-
C0
C500
16
25
METACTINDMetabolic Activating Agent NameNOT APPLICABLE
IVTDTRGIn vitro Treatment Duration Target72
26
17
8325064TX
SetA
SetF
A
F-TA98-
C0
C500
17
26
METACTFLPresence of Metabolic Activation FlagN
IVTDMAXIn vitro Treatment Duration Maximum72.5
27
18
8325064TX
SetA
SetF
A
F-TA98-
C0
C500
18
27
ITVNAM

Intervention Article Name

DMSO
IVTDUIn vitro Treatment Duration UnitHOURS
28
19
8325064TX
SetA
SetF
A
F-TA98-
C0
C500
19
28
ITVTYPE

Intervention Article Type

VEHICLE
INCBTMPIncubation Temperature37
29
20
8325064TX
SetA
SetF
A
F-TA98-
C0
C500
20
29
ITVCONCIntervention Article Concentration100
INCBTMPUIncubation Temperature UnitC
30
21
8325064TX
SetA
SetF
A
F-TA98-
C0
C500
21
30
ITVCONCUIntervention Article Concentration Unit%
ATMRHPAtmospheric Relative Humidity Percent50
31
22
8325064TX
SetA
SetF
A
F-TA98-
C0
C500
22
31
TRTVTreatment VehicleDMSO
ATMCO2PAtmospheric CO2 Percent5
32
23
8325064TXSetFF-TA98-C500
23
32
SPECIESSpeciesSALMONELLA TYPHIMURIUM
SPTOBID

Applicant-defined tobacco identifier

CIG01a
33
24
8325064TXSetFF-TA98-C500
24
33
IVTDMINIn vitro Treatment Duration Minimum71.5
EXPTYP

Exposure Type

Submerged
34
25
8325064TXSetFF-TA98-C500
25
34
IVTDTRGIn vitro Treatment Duration Target72
SAMTYP

Sample Type

Total Particulate Matter in PBS
35
26
8325064TXSetFF-TA98-C500
26
35
IVTDMAXIn vitro Treatment Duration Maximum72.5
APDEVIDApplicant-defined device identifierPUFFMASTER3K
36
27
8325064TXSetFF-TA98-C500
27
36
IVTDUIn vitro Treatment Duration UnitHOURS
SMKRGMSmoking RegimenNON-INTENSE REGIMEN
37
28
8325064TXSetFF-TA98-C500
28
37
INCBTMPIncubation Temperature37
STRAINStrain/SubstrainTA98
38
29
8325064TXSetFF-TA98-C500
29
38
INCBTMPUIncubation Temperature UnitC
MTACTINDMetabolic Activating Agent NameNOT APPLICABLE
39
30
8325064TXSetFF-TA98-C500
30
39
ATMRHPAtmospheric Relative Humidity Percent50
METACTFLPresence of Metabolic Activation FlagN
40
31
8325064TXSetFF-TA98-C500
31
40
ATMCO2PAtmospheric CO2 Percent5
ITVNAM

Intervention Article Name

TA1
41
32
8325064TXSetFF-TA98-C500
32
41
SPTOBID

Applicant-defined tobacco identifier

CIG01a
ITVTYPE

Intervention Article Type

PRODUCT
42
33
8325064TXSetFF-TA98-C500
33
42
EXPTYP

Exposure Type

Submerged
ITVCONCIntervention Article Concentration500
43
34
8325064TXSetFF-TA98-C500
34
43
SAMTYP

Sample Type

Total Particulate Matter in PBS
ITVCONCUIntervention Article Concentration Unitug/plate
44
35
8325064TXSetFF-TA98-C500
35
44
APDEVIDApplicant-defined device identifierPUFFMASTER3K
TRTVTreatment VehicleDMSO
45
36
8325064TX
SetF
SetG
F
G-TA98-
C500
C1600
36
45
SMKRGM
SPECIES
Smoking RegimenNON-INTENSE REGIMEN
SpeciesSALMONELLA TYPHIMURIUM
46
37
8325064TX
SetF
SetG
F
G-TA98-
C500
C1600
37
46
STRAINStrain/SubstrainTA98
IVTDMINIn vitro Treatment Duration Minimum71.5
47
38
8325064TX
SetF
SetG
F
G-TA98-
C500
C1600
38
47
METACTINDMetabolic Activating Agent NameNOT APPLICABLE
IVTDTRGIn vitro Treatment Duration Target72
48
39
8325064TX
SetF
SetG
F
G-TA98-
C500
C1600
39
48
METACTFLPresence of Metabolic Activation FlagN
IVTDMAXIn vitro Treatment Duration Maximum72.5
49
40
8325064TX
SetF
SetG
F
G-TA98-
C500
C1600
40
49
ITVNAM

Intervention Article Name

TA1
IVTDUIn vitro Treatment Duration UnitHOURS
50
41
8325064TX
SetF
SetG
F
G-TA98-
C500
C1600
41
50
ITVTYPE

Intervention Article Type

PRODUCT
INCBTMPIncubation Temperature37
51
42
8325064TX
SetF
SetG
F
G-TA98-
C500
C1600
42
51
ITVCONCIntervention Article Concentration500
INCBTMPUIncubation Temperature UnitC
52
43
8325064TX
SetF
SetG
F
G-TA98-
C500
C1600
43
52
ITVCONCUIntervention Article Concentration Unitug/plate
ATMRHPAtmospheric Relative Humidity Percent50
53
44
8325064TX
SetF
SetG
F
G-TA98-
C500
C1600
44
53
TRTVTreatment VehicleDMSO
ATMCO2PAtmospheric CO2 Percent5
54
45
8325064TXSetGG-TA98-C1600
45
54
SPECIESSpeciesSALMONELLA TYPHIMURIUM
SPTOBID

Applicant-defined tobacco identifier

CIG01a
55
46
8325064TXSetGG-TA98-C1600
46
55
IVTDMINIn vitro Treatment Duration Minimum71.5
EXPTYP

Exposure Type

Submerged
56
47
8325064TXSetGG-TA98-C1600
47
56
IVTDTRGIn vitro Treatment Duration Target72
SAMTYP

Sample Type

Total Particulate Matter in PBS
57
48
8325064TXSetGG-TA98-C1600
48
57
IVTDMAXIn vitro Treatment Duration Maximum72.5
APDEVIDApplicant-defined device identifierPUFFMASTER3K
58
49
8325064TXSetGG-TA98-C1600
49
58
IVTDUIn vitro Treatment Duration UnitHOURS
SMKRGMSmoking RegimenNON-INTENSE REGIMEN
59
50
8325064TXSetGG-TA98-C1600
50
59
INCBTMPIncubation Temperature37
STRAINStrain/SubstrainTA98
60
51
8325064TXSetGG-TA98-C1600
51
60
INCBTMPUIncubation Temperature UnitC
MTACTINDMetabolic Activating Agent NameNOT APPLICABLE
61
52
8325064TXSetGG-TA98-C1600
52
61
ATMRHPAtmospheric Relative Humidity Percent50
METACTFLPresence of Metabolic Activation FlagN
62
53
8325064TXSetGG-TA98-C1600
53
62
ATMCO2PAtmospheric CO2 Percent5
ITVNAM

Intervention Article Name

TA1
63
54
8325064TXSetGG-TA98-C1600
54
63
SPTOBID

Applicant-defined tobacco identifier

CIG01a
ITVTYPE

Intervention Article Type

Product
64
55
8325064TXSetGG-TA98-C1600
55
64
EXPTYP

Exposure Type

Submerged
ITVCONCIntervention Article Concentration1600
65
56
8325064TXSetGG-TA98-C1600
56
65
SAMTYP

Sample Type

Total Particulate Matter in PBS
ITVCONCUIntervention Article Concentration Unitug/plate
66
57
8325064TXSetGG-TA98-C1600
57
66
APDEVIDApplicant-defined device identifierPUFFMASTER3K
TRTVTreatment VehicleDMSO
67
58
8325064TX
SetG

SetR

G
R-
TA98
TA100-
C1600
C2
58
67
SMKRGM
SPECIES
Smoking RegimenNON-INTENSE REGIMEN
SpeciesSALMONELLA TYPHIMURIUM
68
59
8325064TX
SetG

SetR

G
R-
TA98
TA100-
C1600
C2
59
68
STRAINStrain/SubstrainTA98
IVTDMINIn vitro Treatment Duration Minimum71.5
69
60
8325064TX
SetG

SetR

G
R-
TA98
TA100-
C1600
C2
60
69
METACTINDMetabolic Activating Agent NameNOT APPLICABLE
IVTDTRGIn vitro Treatment Duration Target72
70
61
8325064TX
SetG

SetR

G
R-
TA98
TA100-
C1600
C2
61
70
METACTFLPresence of Metabolic Activation FlagN
IVTDMAXIn vitro Treatment Duration Maximum72.5
71
62
8325064TX
SetG

SetR

G
R-
TA98
TA100-
C1600
C2
62
71
ITVNAM

Intervention Article Name

TA1
IVTDUIn vitro Treatment Duration UnitHOURS
72
63
8325064TX
SetG

SetR

G
R-
TA98
TA100-
C1600
C2
63
72
ITVTYPE

Intervention Article Type

Product
INCBTMPIncubation Temperature37
73
64
8325064TX
SetG

SetR

G
R-
TA98
TA100-
C1600
C2
64
73
ITVCONCIntervention Article Concentration1600
INCBTMPUIncubation Temperature UnitC
74
65
8325064TX
SetG

SetR

G
R-
TA98
TA100-
C1600
C2
65
74
ITVCONCUIntervention Article Concentration Unitug/plate
ATMRHPAtmospheric Relative Humidity Percent50
75
66
8325064TX
SetG

SetR

G
R-
TA98
TA100-
C1600
C2
66
75
TRTVTreatment VehicleDMSO
ATMCO2PAtmospheric CO2 Percent5
76
67
8325064TX

SetR

R-TA100-C2
67
76
SPECIESSpeciesSALMONELLA TYPHIMURIUM
SPTOBID

Applicant-defined tobacco identifier

CIG01a
77
68
8325064TX

SetR

R-TA100-C2
68
77
IVTDMINIn vitro Treatment Duration Minimum71.5
EXPTYP

Exposure Type

Submerged
78
69
8325064TX

SetR

R-TA100-C2
69
78
IVTDTRGIn vitro Treatment Duration Target72
SAMTYP

Sample Type

Total Particulate Matter in PBS
79
70
8325064TX

SetR

R-TA100-C2
70
79
IVTDMAXIn vitro Treatment Duration Maximum72.5
APDEVIDApplicant-defined device identifierPUFFMASTER3K
80
71
8325064TX

SetR

R-TA100-C2
71
80
IVTDUIn vitro Treatment Duration UnitHOURS
SMKRGMSmoking RegimenNON-INTENSE REGIMEN
81
72
8325064TX

SetR

R-TA100-C2
72
81
INCBTMPIncubation Temperature37
STRAINStrain/SubstrainTA100
82
73
8325064TX

SetR

R-TA100-C2
73
82
INCBTMPUIncubation Temperature UnitC
MTACTINDMetabolic Activating Agent NameNOT APPLICABLE
83
74
8325064TX

SetR

R-TA100-C2
74
83
ATMRHPAtmospheric Relative Humidity Percent50
METACTFLPresence of Metabolic Activation FlagN
84
75
8325064TX

SetR

R-TA100-C2
75
84
ATMCO2PAtmospheric CO2 Percent5
ITVNAM

Intervention Article Name

NaN3
85
76
8325064TX

SetR

R-TA100-C2
76
85
SPTOBID

Applicant-defined tobacco identifier

CIG01a
ITVTYPE

Intervention Article Type

Positive Control
86
778325064TX

SetR

R-TA100-C277EXPTYP

Exposure Type

Submerged78
8325064TX

SetR

R-TA100-C2
78SAMTYP

Sample Type

Total Particulate Matter in PBS798325064TX

SetR

R-TA100-C279APDEVIDApplicant-defined device identifierPUFFMASTER3K808325064TX

SetR

R-TA100-C280SMKRGMSmoking RegimenNON-INTENSE REGIMEN818325064TX

SetR

R-TA100-C281STRAINStrain/SubstrainTA100828325064TX

SetR

R-TA100-C282METACTINDMetabolic Activating Agent NameNOT APPLICABLE838325064TX

SetR

R-TA100-C283METACTFLPresence of Metabolic Activation FlagN848325064TX

SetR

R-TA100-C284ITVNAM

Intervention Article Name

NaN3858325064TX

SetR

R-TA100-C285ITVTYPE

Intervention Article Type

Positive Control868325064TX

SetR

R-TA100-C286ITVCONCIntervention Article Concentration2878325064TX

SetR

R-TA100-C287ITVCONCUIntervention Article Concentration Unitug/plate888325064TX

SetR

R-TA100-C288TRTVTreatment VehicleDMSO

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,

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-370
trial 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). 

Image Removed

86ITVCONCIntervention Article Concentration2
878325064TX

SetR

R-TA100-C287ITVCONCUIntervention Article Concentration Unitug/plate
888325064TX

SetR

R-TA100-C288TRTVTreatment VehicleDMSO

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, trial 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). 

Image Added


Dataset wrap
Namerelref
Rowcaps
Row 1
Dataset wrap
Namerelref
Rowcaps
serverId

Row 1:

Shows the value of REFID=STM. This REFID refers to the trial set with a SETCD of "SetSTM"

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-489
, 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

1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, DMSO.

Rows 32-76:Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A.
Row 87: 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 1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1.
Rows 98-1110:Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F.
Row 1211: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 1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1.
Rows 1312-1514:Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G.
Row 1615: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 1  and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, NaN3.
Rows 1716-1918:

Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R.

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-668
Dataset2
tableidrelref.xpt

Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

8325064

SetA

A


1

EXPERIMENTAL UNIT/TRIAL SET

2

8325064

SetA

1_1

A

2

OBSERVATIONAL UNIT

3

8325064

SetA

1_2

A

2

OBSERVATIONAL UNIT

4

8325064

SetA

1_3

A

2

OBSERVATIONAL UNIT

5

8325064

SetA

1_4

A

2

OBSERVATIONAL UNIT

6

8325064

SetA

1_5

A

2

OBSERVATIONAL UNIT

7

8325064

SetF

F


1

EXPERIMENTAL UNIT/TRIAL SET

8

8325064

SetF6_1F

2

OBSERVATIONAL UNIT

9

8325064

SetF6_2F

2

OBSERVATIONAL UNIT

10

8325064

SetF

6_3F

2

OBSERVATIONAL UNIT

11

8325064

SetG

G


1

EXPERIMENTAL UNIT/TRIAL SET

12

8325064

SetG7_1G

2

OBSERVATIONAL UNIT

13

8325064

SetG

7_2G

2

OBSERVATIONAL UNIT

14

8325064

SetG7_3G

2

OBSERVATIONAL UNIT

15

8325064

SetG

SetR

R


1

EXPERIMENTAL UNIT/TRIAL SET

16

8325064

SetR18_1R

2

OBSERVATIONAL UNIT

17

8325064

SetR18_2R

2

OBSERVATIONAL UNIT

18

8325064

SetR18_3
R

2

OBSERVATIONAL UNIT

...

R

2

OBSERVATIONAL UNIT

85506ce4-3cb3-3d91-85ee-f633aaaf4a45
Dataset wrap
Namegt
Rowcaps
Rows 1-5: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=7_1 through 7_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T". 

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
columnIdsissuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution
columnskey,summary,type,created,updated,due,assignee,reporter,priority,status,resolution
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-668

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. 
Dataset2
RowSTUDYIDDOMAINGTSEQGTREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRTGTSTRESCGTSTRESNGTSTRESUGTSTATGTREASNDGTMETHODGTDTC
18325064GT11_1RPPRevertant Colony Numbers Per Plate26
NOT APPLICABLE


2626
NOT APPLICABLE
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId
keyTOBA-487




INSTRUMENT COUNTED

2015-08-03
28325064GT21_2RPPRevertant Colony Numbers Per Plate35
NOT APPLICABLE


3535
NOT APPLICABLE



INSTRUMENT COUNTED2015-08-03
38325064GT31_3RPPRevertant Colony Numbers Per Plate39
NOT APPLICABLE


3939
NOT APPLICABLE



INSTRUMENT COUNTED2015-08-03
48325064GT41_4RPPRevertant Colony Numbers Per Plate35
NOT APPLICABLE


3535
NOT APPLICABLE



INSTRUMENT COUNTED

2015-08-03
58325064GT51_5RPPRevertant Colony Numbers Per Plate30
NOT APPLICABLE


3030
NOT APPLICABLE



INSTRUMENT COUNTED2015-08-03
68325064GT6ARPPRevertant Colony Numbers Per Plate33.0
NOT APPLICABLE

MEAN33.033.0
NOT APPLICABLE




2015-08-03
78325064GT7ARPPRevertant Colony Numbers Per Plate5.0
NOT APPLICABLE

STANDARD DEVIATION5.05.0
NOT APPLICABLE




2015-08-03
88325064GT86_1RPPRevertant Colony Numbers Per Plate8
NOT APPLICABLE


88
NOT APPLICABLE



MANUALLY COUNTED2015-08-03
98325064GT96_1CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
108325064GT106_2RPPRevertant Colony Numbers Per Plate10
NOT APPLICABLE


1010
NOT APPLICABLE



MANUALLY COUNTED2015-08-03
118325064GT116_2CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
128325064GT126_3RPPRevertant Colony Numbers Per Plate12
NOT APPLICABLE


1212
NOT APPLICABLE



MANUALLY COUNTED2015-08-03
138325064GT136_3CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
148325064GT14FRPPMEANMean Rev Colony Num Per Plate

10.0

NOT APPLICABLE


MEAN

10.0

10.0

NOT APPLICABLE




2015-08-03
158325064GT15FRPPSTDDVStd Dev Rev Colony Num Per Plate2.0
NOT APPLICABLE

STANDARD DEVIATION2.02.0
NOT APPLICABLE




2015-08-03
168325064GT16FRPPFLDICFold Increase Rev Colony Num Per Plate0.3
NOT APPLICABLE

FOLD INCREASE0.30.3
NOT APPLICABLE




2015-08-03
178325064GT177_1CYTOTOXCytotoxicity

Toxic No Revertant Colonies



T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
188325064GT187_2CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
198325064GT197_3CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
208325064GT2018_1RPPRevertant Colony Numbers Per Plate

812

NOT APPLICABLE


812

812

NOT APPLICABLE



INSTRUMENT COUNTED

2015-08-03
218325064GT2118_2RPPRevertant Colony Numbers Per Plate

912

NOT APPLICABLE


912

912

NOT APPLICABLE




INSTRUMENT COUNTED2015-08-03
228325064GT2218_3RPPRevertant Colony Numbers Per Plate

839

NOT APPLICABLE


839

839

NOT APPLICABLE



INSTRUMENT COUNTED2015-08-03
238325064GT23RRPPMEANMean Rev Colony Num Per Plate854.3
NOT APPLICABLE

MEAN854.3854.3
NOT APPLICABLE




2015-08-03
248325064GT24RRPPSTDDVStd Dev Rev Colony Num Per Plate51.7
NOT APPLICABLE

STANDARD DEVIATION51.751.7
NOT APPLICABLE




2015-08-03
258325064GT25RRPPFLDICFold Increase Rev Colony Num Per Plate6.4
NOT APPLICABLE

FOLD INCREASE6.46.4
NOT APPLICABLE




2015-08-03