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  1. move assumptions out of all of the examples

  2. add row captions to highlight exceptions/assumptions

This is an example showing the report table, trial design, and results from the a study's in vitro bacterial reverse mutation test of Study #8325064. The bacterial reverse mutation test uses four using 4 different amino acid-requiring strains of Salmonella typhimurium (S. typhimurium) and one 1 strain of Escherichia coli (E. coli) to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. The principle of this bacterial reverse mutation test is that it detects chemicals that induce mutations which revert mutations present in the S typhimurium and E. coli tester strains and restore the functional capability of the bacteria to synthesize an essential amino acid. The revertant bacteria are detected by their ability to grow in the absence of the amino acid required by the parent tester strain.

Image Removed

  • Assumption:  When the experimental unit is derived from the species and strain, such as a cell line, then TESTSYS should be supplied.

In this example, the Trial Summary dataset, ts.xpt, includes many informational fields that may provide context at the study level, for Study 8325064.  Also, TSGRPID has been 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. Finally, the Primary Treatment CAS Registry Number is not known and this is recorded as an empty TSVAL and UNKNOWN in the corresponding TSVALNF.

. 

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


Image Added

Image Added

This example Trial Summary (TS) dataset, 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
Dataset wrap
Rowcaps
Rows 1-2:Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study. 
Rows 9-12: TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID=1). The Study Director study director is associated with the Test Facilitytest facility.
Rows 1814-2416:

Show that

this example study includes two different species of bacteria and a total of five strains. 

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 19-27Rows 18-22:Show that TSGRPID (TSGRPID = 2) has been used to link the information for one 1 species (Salmonellasalmonella) with four the 4 different strains and cell lines that are tested in this example this  study.
Rows 2328-2430:

Show that TSGRPID (TSGRPID = 3) has been used to link the information for

one

1 species (

Escherichia

E. coli) with the strain and cell line that is tested in this

example

study.

Dataset2
Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

18325064
Ames
TS1
GLPTYPGood Laboratory Practice TypeFDA
28325064
Ames
TS2
GLPTYPGood Laboratory Practice TypeOECD
38325064
TS1
GLPFLGLP FlagN
48325064
Ames
TS1
STSTDTCStudy Start Date2015-07-29
4

58325064
Ames
TS1
STITLEStudy Title

The Bacterial Reverse Mutation Test, Study 8325064-1

5

68325064
Ames
TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6

78325064
Ames
TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7

88325064
Ames
TS1
SSPONSOR

APPLCNT
Sponsor Organization
ApplicantExample
Sponsor
Applicant Inc.
8

98325064
Ames
TS1
SPREFID

APREFID
Sponsor
Applicant's Study Reference ID
NOT APPLICABLE
9
108325064
Ames
TS
TS
11TSTFNAMTest Facility NameExample Tox Lab Name
10

118325064
Ames
TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11

128325064
Ames
TS11TFCNTRYTest Facility CountryUSA
12

138325064
Ames
TS11STDIRStudy DirectorDr. R. Smith
13

148325064
Ames
TS1
GLPFLGLP FlagN

14

8325064
4TSTGDNAMTesting Guideline NameTest NO. 471
158325064
Ames
TS14
ASTDAssay Standard
TSTGDORGTesting Guideline OrganizationOECD
Test No. 471
15

168325064
Ames
TS14
ASTDV
TSTGDVER
Assay Standard
Testing Guideline Version2020-06-29
16

178325064
Ames
TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17

188325064
Ames
TS1
SSSTYPStudy Sub TypeBacterial Reverse Mutation Test

GNTXAID

Genetic Toxicology Assay Identifier

AMES


19
18
8325064
Ames
TS12

SPECIES

Species
Salmonella

SALMONELLA TYPHIMURIUM

19

208325064
Ames
TS12STRAINStrain/SubstrainTA98
20

218325064
Ames
TS
1
22STRAINStrain/SubstrainTA100
21

228325064
Ames
TS
1
32STRAINStrain/SubstrainTA1535
22

238325064
Ames
TS
1
42STRAINStrain/SubstrainTA1537
23

248325064
Ames
TS1
3
2
SPECIES
CELLLN
SpeciesEscherichia coli

24

8325064AmesTS13STRAINStrainWP2 uvrA pKM101
Expand
titleRaw Data Table for Study 8325064

Image Removed

Image Removed

Cell 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

 

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064
Dataset wrap
Nametx.xpt Trial Sets
Ames
Rowcaps
Rows 1-22: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.,  a concentration level of 0) as shown in the first row, labeled "SetA", in the table Raw Data for Study 8325064.
Rows 23-4:Rows 6-7:Row 13:Rows 1, 6:
Dataset2
RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetA

A-TA98-C01SPECIESSpeciesSalmonella typhimurium
28325064AmesTXSetAA-TA98-C02STRAINStrain/SubstrainTA98
38325064AmesTX

SetA 

A-TA98-C03METACTMetabolic Activation  
48325064AmesTX

SetA 

A-TA98-C04METACTFLY/N presence of metabolic activationN
58325064AmesTXSetAA-TA98-C05TRTDMINTreatment Duration Minimum71.5
68325064AmesTXSetAA-TA98-C06TRTDTRGTreatment Duration Target72
78325064AmesTXSetAA-TA98-C07TRTDMAXTreatment Duration Maximum72.5
88325064AmesTXSetAA-TA98-C08TRTDUTreatment Duration UnitHOURS
98325064AmesTXSetAA-TA98-C09INCBTMPIncubation Temperature37
108325064AmesTXSetAA-TA98-C010INCBTMPUIncubation Temperature UnitC
118325064AmesTXSetAA-TA98-C011HUMIDAtmospheric Relative Humidity  Percent50
128325064AmesTXSetAA-TA98-C012ATMCO2Atmospheric CO2 Percent5
138325064AmesTXSetAA-TA98-C013SPTOBID

Sponsor defined tobacco identifier

CIG01a
148325064AmesTXSetAA-TA98-C014EXPTYP

Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)

Submerged
158325064
TXSetAA-TA98-C0
15
1
SAMTYP 
SPECIES

Sample Type

Total Particulate Matter in PBS
SpeciesSALMONELLA TYPHIMURIUM
2
16
8325064
Ames
TXSetAA-TA98-C0
16
2
INTRVN

name of the intervention article

TA1
IVTDMINIn vitro Treatment Duration Minimum71.5
3
17
8325064
Ames
TX

SetA

A-TA98-C0
17
3
ITVTYPE

type of intervention article

Vehicle Control
IVTDTRGIn vitro Treatment Duration Target72
4
18
8325064
Ames
TX

SetA

A-TA98-C0
18
4
ITVCONCConcentration of intervention article0
IVTDMAXIn vitro Treatment Duration Maximum72.5
58325064
198325064Ames
TXSetAA-TA98-C0
19
5
ITVCONCU
IVTDUIn vitro Treatment Duration
Concentration
Unit
ug/plate
HOURS
20
68325064
Ames
TXSetAA-TA98-C0
20
6
TRTV
INCBTMP
Treatment Vehicle
Incubation Temperature
DMSO
37
21
78325064
Ames
TXSetAA-TA98-C0
21
7
SPDEVIDSponsor defined device identifierPUFFMASTER3K
INCBTMPUIncubation Temperature UnitC
8
22
8325064
Ames
TXSetAA-TA98-C0
22
8
DUREFIDSmoke RegimenMedium Intensity Regimen
ATMRHPAtmospheric Relative Humidity Percent50
98325064
238325064Ames
TX
SetF
SetA
F
A-TA98-
C500
C0
1
9
SPECIES
ATMCO2P
SpeciesSalmonella typhimurium
Atmospheric CO2 Percent5
10
24
8325064
Ames
TX
SetF
SetA
F
A-TA98-
C500
C0
2
10
STRAINStrain/SubstrainTA98
SPTOBID

Applicant-defined tobacco identifier

CIG01a
118325064
258325064Ames
TX
SetF
SetA
F
A-TA98-
C500
C011
3
EXPTYP
METACT

Exposure Type

Metabolic Activation  
Submerged
26
128325064
Ames
TX
SetF

SetA

F
A-TA98-
C500
C0
4
12
METACTFLY/N presence of metabolic activationN
SAMTYP

Sample Type

Total Particulate Matter in PBS
13
27
8325064
Ames
TX
SetF

SetA

F
A-TA98-
C500
C0
5
13
TRTDMINTreatment Duration Minimum71.5
APDEVIDApplicant-defined device identifierPUFFMASTER3K
14
28
8325064
Ames
TX
TXF
SetA
SetF
A-TA98-
C500
C0
6
14
TRTDTRGTreatment Duration Target72298325064
SMKRGMSmoking RegimenNON-INTENSE REGIMEN
158325064
Ames
TX
SetF
SetA
F
A-TA98-
C500
C0
7
15
TRTDMAXTreatment Duration Maximum72.5
STRAINStrain/SubstrainTA98
16
30
8325064
Ames
TX
SetF
SetA
F
A-TA98-
C500
C0
8
16
TRTDUTreatment Duration UnitHOURS
MTACTINDMetabolic Activating Agent NameNOT APPLICABLE
17
31
8325064
Ames
TX
TXF
SetA
SetF
A-TA98-
C500
C0
9
17
INCBTMPIncubation Temperature37
METACTFLPresence of Metabolic Activation FlagN
18
32
8325064
Ames
TX
SetF
SetA
F
A-TA98-
C500
C0
10
18
INCBTMPUIncubation Temperature UnitC
ITVNAM

Intervention Article Name

DMSO
19
33
8325064
Ames
TX
SetF
SetA
F
A-TA98-
C500
C0
11
19
HUMIDAtmospheric Relative Humidity  Percent50
ITVTYPE

Intervention Article Type

VEHICLE
20
34
8325064
Ames
TX
SetF
SetA
F
A-TA98-
C500
C0
12
20
ATMCO2Atmospheric CO2 Percent5358325064
ITVCONCIntervention Article Concentration100
218325064
Ames
TX
SetF
SetA
F
A-TA98-
C500
C0
13
21
SPTOBID

Sponsor defined tobacco identifier

CIG01a368325064
ITVCONCUIntervention Article Concentration Unit%
228325064
Ames
TX
SetF
SetA
F
A-TA98-
C500
C0
14
22
EXPTYP

Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)

Submerged
TRTVTreatment VehicleDMSO
23
37
8325064
Ames
TXSetFF-TA98-C500
15
23
SAMTYP 
SPECIES

Sample Type

Total Particulate Matter in PBS
SpeciesSALMONELLA TYPHIMURIUM
24
38
8325064
Ames
TXSetFF-TA98-C500
16
24
INTRVN

name of the intervention article

TA1
IVTDMINIn vitro Treatment Duration Minimum71.5
258325064
398325064Ames
TXSetFF-TA98-C500
17
25
ITVTYPE

type of intervention article

Vehicle Control
IVTDTRGIn vitro Treatment Duration Target72
26
40
8325064
Ames
TXSetFF-TA98-C500
18
26
ITVCONCConcentration of intervention article0
IVTDMAXIn vitro Treatment Duration Maximum72.5
27
41
8325064
Ames
TXSetFF-TA98-C500
19
27
ITVCONCU
IVTDUIn vitro Treatment Duration
Concentration
Unit
ug/plate
HOURS
42
288325064
Ames
TXSetFF-TA98-C500
20
28
TRTV
INCBTMP
Treatment Vehicle
Incubation Temperature
DMSO
37
43
298325064
Ames
TXSetFF-TA98-C500
21
29
SPDEVIDSponsor defined device identifierPUFFMASTER3K
INCBTMPUIncubation Temperature UnitC
30
44
8325064
Ames
TXSetFF-TA98-C500
22
30
DUREFIDSmoke RegimenMedium Intensity Regimen454647488325064AmesTX

SetG (row 7) do G not I!!!

METACTMetabolic Activation  (should there be two parms? Presence, type)?None8325064AmesTXSetGTRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)8325064AmesTXSetGTRTDRTOLTreatment Duration Tolerance8325064AmesTXSetGTRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)8325064AmesTXSetGINTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

2-Nitrofluorine8325064AmesTXSetGITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control8325064AmesTXSetGITVCONCConcentration of intervention article58325064AmesTXSetGITVCONCUConcentration Unitug/plate8325064AmesTXSetGREGIMESmoking RegimeISO...SetG8325064AmesTX

SetR

(Row 18)

METACTMetabolic Activation  (should there be two parms? Presence, type)?None8325064AmesTX

SetR

TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)8325064AmesTXSetRTRTDRTOLTreatment Duration Tolerance8325064AmesTXSetRTRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)8325064AmesTXSetRINTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

4-Nitroquinoline-1-oxide8325064AmesTXSetRITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Positive Control8325064AmesTXSetRITVCONCConcentration of intervention article28325064AmesTXSetRITVCONCUConcentration Unitug/plate8325064AmesTXSetRSTRAINStrain/SubstrainTA988325064AmesTXSetRREGIMESmoking RegimeISO

Observational Unit Identifiers (OBUIDs) are defined by the sponsor to uniquely identify the observational unit within an experimental unit. In this example the sponsor chose to define the EUIDs based on trial sets (e.g., F) and OBUIDs based on the position of the tube in one of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).

...

Nameou.xpt Observational and Experimentat Unit Identifiers

...

ATMRHPAtmospheric Relative Humidity Percent50
318325064TXSetFF-TA98-C50031ATMCO2PAtmospheric CO2 Percent5
328325064TXSetFF-TA98-C50032SPTOBID

Applicant-defined tobacco identifier

CIG01a
338325064TXSetFF-TA98-C50033EXPTYP

Exposure Type

Submerged
348325064TXSetFF-TA98-C50034SAMTYP

Sample Type

Total Particulate Matter in PBS
358325064TXSetFF-TA98-C50035APDEVIDApplicant-defined device identifierPUFFMASTER3K
368325064TXSetFF-TA98-C50036SMKRGMSmoking RegimenNON-INTENSE REGIMEN
378325064TXSetFF-TA98-C50037STRAINStrain/SubstrainTA98
388325064TXSetFF-TA98-C50038MTACTINDMetabolic Activating Agent NameNOT APPLICABLE
398325064TXSetFF-TA98-C50039METACTFLPresence of Metabolic Activation FlagN
408325064TXSetFF-TA98-C50040ITVNAM

Intervention Article Name

TA1
418325064TXSetFF-TA98-C50041ITVTYPE

Intervention Article Type

PRODUCT
428325064TXSetFF-TA98-C50042ITVCONCIntervention Article Concentration500
438325064TXSetFF-TA98-C50043ITVCONCUIntervention Article Concentration Unitug/plate
448325064TXSetFF-TA98-C50044TRTVTreatment VehicleDMSO
458325064TXSetGG-TA98-C160045SPECIESSpeciesSALMONELLA TYPHIMURIUM
468325064TXSetGG-TA98-C160046IVTDMINIn vitro Treatment Duration Minimum71.5
478325064TXSetGG-TA98-C160047IVTDTRGIn vitro Treatment Duration Target72
488325064TXSetGG-TA98-C160048IVTDMAXIn vitro Treatment Duration Maximum72.5
498325064TXSetGG-TA98-C160049IVTDUIn vitro Treatment Duration UnitHOURS
508325064TXSetGG-TA98-C160050INCBTMPIncubation Temperature37
518325064TXSetGG-TA98-C160051INCBTMPUIncubation Temperature UnitC
528325064TXSetGG-TA98-C160052ATMRHPAtmospheric Relative Humidity Percent50
538325064TXSetGG-TA98-C160053ATMCO2PAtmospheric CO2 Percent5
548325064TXSetGG-TA98-C160054SPTOBID

Applicant-defined tobacco identifier

CIG01a
558325064TXSetGG-TA98-C160055EXPTYP

Exposure Type

Submerged
568325064TXSetGG-TA98-C160056SAMTYP

Sample Type

Total Particulate Matter in PBS
578325064TXSetGG-TA98-C160057APDEVIDApplicant-defined device identifierPUFFMASTER3K
588325064TXSetGG-TA98-C160058SMKRGMSmoking RegimenNON-INTENSE REGIMEN
598325064TXSetGG-TA98-C160059STRAINStrain/SubstrainTA98
608325064TXSetGG-TA98-C160060MTACTINDMetabolic Activating Agent NameNOT APPLICABLE
618325064TXSetGG-TA98-C160061METACTFLPresence of Metabolic Activation FlagN
628325064TXSetGG-TA98-C160062ITVNAM

Intervention Article Name

TA1
638325064TXSetGG-TA98-C160063ITVTYPE

Intervention Article Type

Product
648325064TXSetGG-TA98-C160064ITVCONCIntervention Article Concentration1600
658325064TXSetGG-TA98-C160065ITVCONCUIntervention Article Concentration Unitug/plate
668325064TXSetGG-TA98-C160066TRTVTreatment VehicleDMSO
678325064TX

SetR

R-TA100-C267SPECIESSpeciesSALMONELLA TYPHIMURIUM
688325064TX

SetR

R-TA100-C268IVTDMINIn vitro Treatment Duration Minimum71.5
698325064TX

SetR

R-TA100-C269IVTDTRGIn vitro Treatment Duration Target72
708325064TX

SetR

R-TA100-C270IVTDMAXIn vitro Treatment Duration Maximum72.5
718325064TX

SetR

R-TA100-C271IVTDUIn vitro Treatment Duration UnitHOURS
728325064TX

SetR

R-TA100-C272INCBTMPIncubation Temperature37
738325064TX

SetR

R-TA100-C273INCBTMPUIncubation Temperature UnitC
748325064TX

SetR

R-TA100-C274ATMRHPAtmospheric Relative Humidity Percent50
758325064TX

SetR

R-TA100-C275ATMCO2PAtmospheric CO2 Percent5
768325064TX

SetR

R-TA100-C276SPTOBID

Applicant-defined tobacco identifier

CIG01a
778325064TX

SetR

R-TA100-C277EXPTYP

Exposure Type

Submerged
788325064TX

SetR

R-TA100-C278SAMTYP

Sample Type

Total Particulate Matter in PBS
798325064TX

SetR

R-TA100-C279APDEVIDApplicant-defined device identifierPUFFMASTER3K
808325064TX

SetR

R-TA100-C280SMKRGMSmoking RegimenNON-INTENSE REGIMEN
818325064TX

SetR

R-TA100-C281STRAINStrain/SubstrainTA100
828325064TX

SetR

R-TA100-C282MTACTINDMetabolic Activating Agent NameNOT APPLICABLE
838325064TX

SetR

R-TA100-C283METACTFLPresence of Metabolic Activation FlagN
848325064TX

SetR

R-TA100-C284ITVNAM

Intervention Article Name

NaN3
858325064TX

SetR

R-TA100-C285ITVTYPE

Intervention Article Type

Positive Control
868325064TX

SetR

R-TA100-C286ITVCONCIntervention 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:

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=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 2-6:Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A.
Row 7: 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=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 8-10:Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F.
Row 11: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=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 12-14:Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G.
Row 15: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=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 16-18:

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

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

SetR

R


1

EXPERIMENTAL UNIT/TRIAL SET

16

8325064

SetR18_1R

2

OBSERVATIONAL UNIT

17

8325064

SetR18_2R

2

OBSERVATIONAL UNIT

18

8325064

SetR18_3R

2

OBSERVATIONAL UNIT

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
RowSTUDYIDDOMAINGTSEQGTREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRT
Dataset2
tableidou.xpt
RowSTUDYIDASSAYIDDOMAINSETCD EUID OBUID  
18325064AmesOUSetAA0_1
28325064AmesOUSetAA0_2
38325064AmesOUSetAA0_3
48325064AmesOUSetAA0_4
58325064AmesOUSetAA0_5

6

8325064AmesOUSetFF6_1
78325064AmesOUSetFF6_2
88325064AmesOUSetFF6_3
98325064AmesOUSetGG7_1
108325064AmesOUSetGG7_2
118325064AmesOUSetG

G

7_3
128325064AmesOUSetRR18_1
138325064AmesOUSetRR18_2
148325064AmesOUSetRR18_3
Expand
titleRaw Data Table for Study 8325064

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Dataset wrap
Namegt.xpt
GTCOLSRT (coll. summ. result type)
Rowcaps
Rows 1-7:Show values collected for the set, SetA. 
Rows 8-16:Shows values collected for the set, SetF.  Revertent colonies were counted and each value is associated with a record to show a postfix of code of "V".
Rows 17-19:Shows values collected for the set, SetG. Each record for this EUID shows the postfix code of "T".  No revertent colonies were counted and there are no summary values collected. 
Rows 20-25:Shows values collected for the set, SetR.  
Rows 6,7,14,15,16, 23,24,25:Show summary values collected (e.g., MEAN, STANDARD DEVIATION, and/or FOLD INCREASE) that apply to all of the observational units within the experimental unit, as shown by OBUID = "ALL". 
Dataset2
RowSTUDYIDASSAYIDDOMAINTXSETCDEUIDOUIDGTSEQGTTESTCDGTTESTGTORRESGTORRESU
GTSTRESCGTSTRESNGTSTRESUGTSTATGTREASNDGTMETHODGTDTC
18325064
Ames
GT
SETA 0
1
A
1_
1
1RPPRevertant Colony Numbers Per Plate26
COLONIES


2626
COLONIES




INSTRUMENT COUNTED

2015-08-03
28325064
Ames
GT
SETA 0
2
A
1_2
2
RPPRevertant Colony Numbers Per Plate35
COLONIES


3535
COLONIES



INSTRUMENT COUNTED2015-08-03
38325064
Ames
GT
SETA 0
3
A
1_3
3
RPPRevertant Colony Numbers Per Plate39
COLONIES


3939
COLONIES



INSTRUMENT COUNTED2015-08-03
48325064
Ames
GT
SETA 0
4
A
1_4
4
RPPRevertant Colony Numbers Per Plate35
COLONIES


3535
COLONIES



INSTRUMENT COUNTED

2015-08-03
58325064
Ames
GT
SETA A
0_
51_5RPPRevertant Colony Numbers Per Plate30
COLONIES


3030
COLONIES



INSTRUMENT COUNTED2015-08-03
68325064
Ames
GT
SETA 
6A
ALL6
RPPRevertant Colony Numbers Per Plate33.0
COLONIES

MEAN33.033.0
COLONIES




2015-08-03
78325064
Ames
GT
SETA 
7A
ALL7
RPPRevertant Colony Numbers Per Plate5.0
COLONIES

STANDARD DEVIATION5.05.0
COLONIES




2015-08-03
88325064
Ames
GT
SETF
8
F
6_
1
1RPPRevertant Colony Numbers Per Plate8
COLONIES


88
COLONIES



MANUALLY COUNTED2015-08-03
98325064
Ames
GT
SETF
9
F
6_1
2
CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
108325064
Ames
GT
SETF 
10
F
6_2
3
RPPRevertant Colony Numbers Per Plate10
COLONIES


1010
COLONIES



MANUALLY COUNTED2015-08-03
118325064
AmesF
GT
SETF
116_2
2
CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
128325064
Ames
GT
SETF 
12
F
6_3
4
RPPRevertant Colony Numbers Per Plate12
COLONIES


1212
COLONIES



MANUALLY COUNTED2015-08-03
138325064
Ames
GT
SETF
13
F
6_3
2
CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
148325064
Ames
GT
SETF
14F
ALL
5
RPPMEANMean
of Revertant Numbers
Rev Colony Num Per Plate

10.0

COLONIES

MEAN

10.0

10.0

COLONIES





2015-08-03
158325064
Ames
GT
SETF 
15F
ALL6
RPPSTDDV
Standard Deviation of Revertant Numbers
Std Dev Rev Colony Num Per Plate2.0
COLONIES

STANDARD DEVIATION2.02.0
COLONIES




2015-08-03
168325064
Ames
GT
SETF 
16F
ALL7RPPFDINC
RPPFLDICFold Increase
of Revertant Numbers
Rev Colony Num Per Plate0.3
COLONIES

FOLD INCREASE0.30.3
COLONIES




2015-08-03
178325064
Ames
GT
SETG5
17
G
7_1
1
CYTOTOXCytotoxicity

Toxic No

Revertant 

Revertant Colonies



T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
188325064
Ames
GT
SETG5
18
G
7_2
2
CYTOTOXCytotoxicityToxic No
Revertant 
Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
198325064
Ames
GT
SETG5
19
G
7_3
3
CYTOTOXCytotoxicityToxic No
Revertant 
Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
208325064
AmesR
GT
SETR
2018_1
1
RPPRevertant Colony Numbers Per Plate

812

COLONIES


812

812

COLONIES



INSTRUMENT COUNTED

2015-08-03
218325064
Ames
GT
SETR
21
R
18_2
2
RPPRevertant Colony Numbers Per Plate

912

COLONIES



912

912

COLONIES




INSTRUMENT COUNTED2015-08-03
228325064
AmesR
GT
SETR
2218_3
3
RPPRevertant Colony Numbers Per Plate

839

COLONIES


839

839

COLONIES



INSTRUMENT COUNTED2015-08-03
238325064
Ames
GT
SETR
23R
ALL4
RPPMEANMean
of Revertant Numbers
Rev Colony Num Per Plate854.3
COLONIES

MEAN854.3854.3
COLONIES




2015-08-03
248325064
Ames
GT
SETR
24R
ALL
5
RPPSTDDV
Standard Deviation of Revertant Numbers
Std Dev Rev Colony Num Per Plate51.7
COLONIES

STANDARD DEVIATION51.751.7
COLONIES




2015-08-03
258325064
Ames
GT
SETR
25R
ALL
RPPFLDIC
6RPPFLDINC
Fold Increase
of Revertant Numbers
Rev Colony Num Per Plate6.4
COLONIES

FOLD INCREASE6.46.4
COLONIES




2015-08-03