Versions Compared

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 the a study's in vitro bacterial reverse mutation test of an example study, Study #8325064. This 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 pairsjira

Expand

...

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

...

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 three 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 sponsor defined trial set label (e.g., SetA).  For brevity, the remaining tables (e.g., additional strains, samples prepared without metabolic activation, etc.) are not included.

Image Removed

Image Removed

Dataset wrap
Rowcaps
Rows 1-2:

Show

two

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

since

 since both GLP

Types

types apply for

this example

this  study. 

Row 83: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 the sponsor's study reference ID is not applicable.
Rows 910-1213:Show that 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. 

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 19-27Rows 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

GNTXAID

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
TS11TSTFNAMTest 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
TS1
ASTDV
4TSTGDVERTesting Guideline
Assay Standard
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
TS
TS19
12

SPECIES

Species

SALMONELLA TYPHIMURIUM

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

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

8325064AmesTS13STRAINStrain/SubstrainWP2 uvrA pKM101

This example trial set dataset, tx.xpt, shows information about the test conditions for SetA and SetR in this example study. For brevity, this does not show information for SetF, SetG, or any other sets.  A fully formed tx.xpt for this example study would include information about the test conditions for all sets. 

...

Nametx

...

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

...

...

  •   The TO domain is described in

...

...

  • 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)

...

...

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.
du.xpt in SDTM Example.Product HPHC ENDS Testing.

The DU domain is described in the Section 2.8.9.8 Device-In-Use (DU).

Dataset2

 

Dataset2

Aug 23: LAK add F & G to TX and add G data to GT.

RowSTUDYIDGNTXAIDDOMAINSETCDSET
RowSTUDYIDDOMAINSETCDSET
TXSEQTXPARMCDTXPARMTXVAL
18325064
Ames
TXSetAA-TA98-C01SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064
Ames
TXSetAA-TA98-C02
STRAINStrain/Substrain
IVTDMINIn vitro Treatment Duration Minimum71.5
TA98
38325064
Ames
TX

SetA

A-TA98-C03
METACTMetabolic ActivationNOT APPLICABLE
IVTDTRGIn vitro Treatment Duration Target72
48325064
Ames
TX

SetA

A-TA98-C04
METACTFLY/N presence of metabolic activation
IVTDMAXIn vitro Treatment Duration Maximum72.5
N
58325064
Ames
TXSetAA-TA98-C05
TRTDMIN
IVTDUIn vitro Treatment Duration
Minimum
Unit
71.5
HOURS
68325064
Ames
TXSetAA-TA98-C06
TRTDTRGTreatment Duration Target
INCBTMPIncubation Temperature37
72
78325064
Ames
TXSetAA-TA98-C07
TRTDMAXTreatment Duration Maximum
INCBTMPUIncubation Temperature UnitC
72.5
88325064
Ames
TXSetAA-TA98-C08
TRTDUTreatment Duration Unit
ATMRHPAtmospheric Relative Humidity Percent50
HOURS
98325064
Ames
TXSetAA-TA98-C09
INCBTMPIncubation Temperature
ATMCO2PAtmospheric CO2 Percent5
37
108325064
Ames
TXSetAA-TA98-C010
INCBTMPUIncubation Temperature Unit
SPTOBID

Applicant-defined tobacco identifier

CIG01a
C
118325064
Ames
TXSetAA-TA98-C011
HUMIDAtmospheric Relative Humidity Percent
EXPTYP

Exposure Type

Submerged
50
128325064
Ames
TX

SetA

A-TA98-C012
ATMCO2Atmospheric CO2 Percent
SAMTYP

Sample Type

Total Particulate Matter in PBS
5
138325064
Ames
TX

SetA

A-TA98-C013
SPTOBID
APDEVID
Sponsor
Applicant-defined
tobacco
device identifier
CIG01a
PUFFMASTER3K
148325064
Ames
TXSetAA-TA98-C014
EXPTYP
SMKRGM

Exposure Type

Smoking RegimenNON-INTENSE REGIMEN
Submerged
158325064
Ames
TXSetAA-TA98-C015
SAMTYP

Sample Type

STRAINStrain/SubstrainTA98
Total Particulate Matter in PBS
168325064
Ames
TXSetAA-TA98-C016
INTRVN
MTACTIND

Name of the intervention article

Metabolic Activating Agent NameNOT APPLICABLE
TA1
178325064
Ames
TXSetAA-TA98-C017
ITVTYPE
METACTFL

Type of intervention article

Presence of Metabolic Activation FlagN
Vehicle Control
188325064
Ames
TXSetAA-TA98-C018
ITVCONCConcentration of intervention article0
ITVNAM

Intervention Article Name

DMSO
198325064
Ames
TXSetAA-TA98-C019
ITVCONCUConcentration Unit
ITVTYPE

Intervention Article Type

VEHICLE
ug/plate
208325064
Ames
TXSetAA-TA98-C020
TRTVTreatment Vehicle
ITVCONCIntervention Article Concentration100
DMSO
218325064
Ames
TXSetAA-TA98-C021
SPDEVIDSponsor defined device identifier
ITVCONCUIntervention Article Concentration Unit%
PUFFMASTER3K
228325064
Ames
TXSetAA-TA98-C022
DUREFID
TRTV
Smoke Regimen
Treatment VehicleDMSO
NON-INTENSE REGIMEN
238325064
Ames
TXSetFF-TA98-C50023SPECIESSpeciesSALMONELLA TYPHIMURIUM
248325064
Ames
TXSetFF-TA98-C50024
STRAINStrain/Substrain
IVTDMINIn vitro Treatment Duration Minimum71.5
TA98
258325064
Ames
TXSetFF-TA98-C50025
METACTMetabolic Activation
IVTDTRGIn vitro Treatment Duration Target72
NOT APPLICABLE
268325064
Ames
TXSetFF-TA98-C50026
METACTFLY/N presence of metabolic activation
IVTDMAXIn vitro Treatment Duration Maximum72.5
N
278325064
Ames
TXSetFF-TA98-C50027
TRTDMIN
IVTDUIn vitro Treatment Duration
Minimum
Unit
71.5
HOURS
288325064
Ames
TXSetFF-TA98-C50028
TRTDTRGTreatment Duration Target
INCBTMPIncubation Temperature37
72
298325064
Ames
TXSetFF-TA98-C50029
TRTDMAXTreatment Duration Maximum
INCBTMPUIncubation Temperature UnitC
72.5
308325064
Ames
TXSetFF-TA98-C50030
TRTDUTreatment Duration Unit
ATMRHPAtmospheric Relative Humidity Percent50
HOURS
318325064
Ames
TXSetFF-TA98-C50031
INCBTMPIncubation Temperature
ATMCO2PAtmospheric CO2 Percent5
37
328325064
Ames
TXSetFF-TA98-C50032
INCBTMPUIncubation Temperature Unit
SPTOBID

Applicant-defined tobacco identifier

CIG01a
C
338325064
Ames
TXSetFF-TA98-C50033
HUMIDAtmospheric Relative Humidity Percent
EXPTYP

Exposure Type

Submerged
50
348325064
Ames
TXSetFF-TA98-C50034
ATMCO2Atmospheric CO2 Percent
SAMTYP

Sample Type

Total Particulate Matter in PBS
5
358325064
Ames
TXSetFF-TA98-C50035
SPTOBID
APDEVID
Sponsor
Applicant-defined
tobacco
device identifier
CIG01a
PUFFMASTER3K
368325064
Ames
TXSetFF-TA98-C50036
EXPTYP
SMKRGM

Exposure Type

Smoking RegimenNON-INTENSE REGIMEN
Submerged
378325064
Ames
TXSetFF-TA98-C50037
SAMTYP

Sample Type

STRAINStrain/SubstrainTA98
Total Particulate Matter in PBS
388325064
Ames
TXSetFF-TA98-C50038
INTRVN
MTACTIND

Name of the intervention article

Metabolic Activating Agent NameNOT APPLICABLE
TA1
398325064
Ames
TXSetFF-TA98-C50039
ITVTYPE
METACTFL

Type of intervention article

Presence of Metabolic Activation FlagN
Vehicle Control
408325064
Ames
TXSetFF-TA98-C50040
ITVCONCConcentration of intervention article
ITVNAM

Intervention Article Name

TA1
500
418325064
Ames
TXSetFF-TA98-C50041
ITVCONCUConcentration Unit
ITVTYPE

Intervention Article Type

PRODUCT
ug/plate
428325064
Ames
TXSetFF-TA98-C50042
TRTVTreatment Vehicle
ITVCONCIntervention Article Concentration500
DMSO
438325064
Ames
TXSetFF-TA98-C50043
SPDEVIDSponsor defined device identifier
ITVCONCUIntervention Article Concentration Unitug/plate
PUFFMASTER3K
448325064
Ames
TXSetFF-TA98-C50044
DUREFID
TRTV
Smoke Regimen
Treatment VehicleDMSO
NON-INTENSE REGIMEN
458325064
Ames
TXSetGG-TA98-C160045SPECIESSpeciesSALMONELLA TYPHIMURIUM
468325064
Ames
TXSetGG-TA98-C160046
STRAINStrain/Substrain
IVTDMINIn vitro Treatment Duration Minimum71.5
TA98
478325064
Ames
TXSetGG-TA98-C160047
METACTMetabolic Activation
IVTDTRGIn vitro Treatment Duration Target72
NOT APPLICABLE
488325064
Ames
TXSetGG-TA98-C160048
METACTFLY/N presence of metabolic activation
IVTDMAXIn vitro Treatment Duration Maximum72.5
N
498325064
Ames
TXSetGG-TA98-C160049
TRTDMIN
IVTDUIn vitro Treatment Duration
Minimum
Unit
71.5
HOURS
508325064
Ames
TXSetGG-TA98-C160050
TRTDTRGTreatment Duration Target
INCBTMPIncubation Temperature37
72
518325064
Ames
TXSetGG-TA98-C160051
TRTDMAXTreatment Duration Maximum
INCBTMPUIncubation Temperature UnitC
72.5
528325064
Ames
TXSetGG-TA98-C160052
TRTDUTreatment Duration Unit
ATMRHPAtmospheric Relative Humidity Percent50
HOURS
538325064
Ames
TXSetGG-TA98-C160053
INCBTMPIncubation Temperature
ATMCO2PAtmospheric CO2 Percent5
37
548325064
Ames
TXSetGG-TA98-C160054
INCBTMPUIncubation Temperature Unit
SPTOBID

Applicant-defined tobacco identifier

CIG01a
C
558325064
Ames
TXSetGG-TA98-C1600
HUMIDAtmospheric Relative Humidity Percent
55EXPTYP

Exposure Type

Submerged
50
568325064
Ames
TXSetGG-TA98-C1600
ATMCO2Atmospheric CO2 Percent
56SAMTYP

Sample Type

Total Particulate Matter in PBS
5
578325064
Ames
TXSetGG-TA98-C160057
SPTOBID
APDEVID
Sponsor
Applicant-defined
tobacco
device identifier
CIG01a
PUFFMASTER3K
588325064
Ames
TXSetGG-TA98-C1600
EXPTYP

Exposure Type

58SMKRGMSmoking RegimenNON-INTENSE REGIMEN
Submerged
598325064
Ames
TXSetGG-TA98-C1600
SAMTYP

Sample Type

59STRAINStrain/SubstrainTA98
Total Particulate Matter in PBS
608325064
Ames
TXSetGG-TA98-C160060
INTRVN
MTACTIND

Name of the intervention article

Metabolic Activating Agent NameNOT APPLICABLE
TA1
618325064
Ames
TXSetGG-TA98-C160061
ITVTYPE
METACTFL

Type of intervention article

Presence of Metabolic Activation FlagN
Vehicle Control
628325064
Ames
TXSetGG-TA98-C160062
ITVCONCConcentration of intervention article
ITVNAM

Intervention Article Name

TA1
1600
638325064
Ames
TXSetGG-TA98-C160063
ITVCONCUConcentration Unit
ITVTYPE

Intervention Article Type

Product
ug/plate
648325064
Ames
TXSetGG-TA98-C160064
TRTVTreatment Vehicle
ITVCONCIntervention Article Concentration1600
DMSO
658325064
Ames
TXSetGG-TA98-C160065
SPDEVIDSponsor defined device identifier
ITVCONCUIntervention Article Concentration Unitug/plate
PUFFMASTER3K
668325064
Ames
TXSetGG-TA98-C1600
DUREFIDSmoke Regimen
66TRTVTreatment VehicleDMSO
NON-INTENSE REGIMEN
678325064
Ames
TX

SetR

R-TA100-C267SPECIESSpecies
Salmonella typhimurium
SALMONELLA TYPHIMURIUM
688325064
Ames
TX

SetR

R-TA100-C268
STRAINStrain/Substrain
IVTDMINIn vitro Treatment Duration Minimum71.5
TA100
698325064
Ames
TX

SetR

R-TA100-C2
METACTMetabolic Activation
69IVTDTRGIn vitro Treatment Duration Target72
NOT APPLICABLE
708325064
Ames
TX

SetR

R-TA100-C270
METACTFLY/N presence of metabolic activation
IVTDMAXIn vitro Treatment Duration Maximum72.5
N
718325064
Ames
TX

SetR

R-TA100-C271
TRTDMIN
IVTDUIn vitro Treatment Duration
Minimum
Unit
71.5
HOURS
728325064
Ames
TX

SetR

R-TA100-C272
TRTDTRGTreatment Duration Target
INCBTMPIncubation Temperature37
72
738325064
Ames
TX

SetR

R-TA100-C2
TRTDMAXTreatment Duration Maximum
73INCBTMPUIncubation Temperature UnitC
72.5
748325064
Ames
TX

SetR

R-TA100-C274
TRTDUTreatment Duration Unit
ATMRHPAtmospheric Relative Humidity Percent50
HOURS
758325064
Ames
TX

SetR

R-TA100-C275
INCBTMPIncubation Temperature
ATMCO2PAtmospheric CO2 Percent5
37
768325064
Ames
TX

SetR

R-TA100-C2
INCBTMPUIncubation Temperature Unit
76SPTOBID

Applicant-defined tobacco identifier

CIG01a
C
778325064
Ames
TX

SetR

R-TA100-C2
HUMIDAtmospheric Relative Humidity Percent
77EXPTYP

Exposure Type

Submerged
50
788325064
Ames
TX

SetR

R-TA100-C2
ATMCO2Atmospheric CO2 Percent
78SAMTYP

Sample Type

Total Particulate Matter in PBS
5
798325064
Ames
TX

SetR

R-TA100-C279
SPTOBID
APDEVID
Sponsor
Applicant-defined
tobacco
device identifier
CIG01a
PUFFMASTER3K
808325064
Ames
TX

SetR

R-TA100-C2
EXPTYP

Exposure Type

80SMKRGMSmoking RegimenNON-INTENSE REGIMEN
Submerged
818325064
Ames
TX

SetR

R-TA100-C2
SAMTYP

Sample Type

81STRAINStrain/SubstrainTA100
Total Particulate Matter in PBS
828325064
Ames
TX

SetR

R-TA100-C282
INTRVN

name of the intervention article

MTACTINDMetabolic Activating Agent NameNOT APPLICABLE
TA1
838325064
Ames
TX

SetR

R-TA100-C2
ITVTYPE
83METACTFL

type of intervention article

Presence of Metabolic Activation FlagN
Positive Control
848325064
Ames
TX

SetR

R-TA100-C2
ITVCONCConcentration of intervention article
84ITVNAM

Intervention Article Name

NaN3
2
858325064
Ames
TX

SetR

R-TA100-C2
ITVCONCUConcentration Unit
85ITVTYPE

Intervention Article Type

Positive Control
ug/plate
868325064
Ames
TX

SetR

R-TA100-C286
TRTVTreatment Vehicle
ITVCONCIntervention Article Concentration2
DMSO
878325064
Ames
TX

SetR

R-TA100-C2
SPDEVIDSponsor defined device identifier
87ITVCONCUIntervention Article Concentration Unitug/plate
PUFFMASTER3K
888325064
Ames
TX

SetR

R-TA100-C288
DUREFID
TRTV
Smoke Regimen
Treatment VehicleDMSO
NON-INTENSE REGIMEN

REFID values are defined by the applicant to uniquely identify the observational unit within an experimental unit.   In the simplified picture 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 our the example study, 8325064.   For 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 one 1 of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1). 


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

trial set

TX dataset

, tx

.

xpt. 

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
five
5 observational units
0
(1_1 through
0
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
trial set
TX dataset
, tx.xpt.  LEVEL=1 and LVLDESC='TRIAL SET'
. 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
three
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
trial set
TX dataset
, tx
.
xpt. 
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
three
3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=
F
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
trial set dataset, tx.xpt. 
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

three observational units 18_1 through 18_3 that are within the parent experimental unit, REFID=F

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

Dataset2
tableidrelref.xpt

Row

STUDYID

Dataset2
tableidrelref.xpt

1.For each Unique GNTXAID (For each unique  value in Parent, there must be one and only one record in REFID column with a value matching that Parent value.)

"For each PARENT value within the same GNTXAID value there must be one and only one record with REFID = the value in PARENT"

2. The value of level for a record with Parent populated, that level must be one greater than it’s parent record.

GNTXAIDAmesAmes0Ames04Ames03A5Ames04A6Ames05A7AmesF8Ames6F9Ames6F10Ames6F11SetGG12Ames7G13Ames7G14Ames7G15

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

SetF

SetA

6_
1
F

2

OBSERVATIONAL UNIT

9

8325064

SetF

SetA

6_
2
F

2

OBSERVATIONAL UNIT

10

8325064

SetF

SetA

6_
3
F

2

OBSERVATIONAL UNIT

11

8325064

SetG

SetF

G


1

EXPERIMENTAL UNIT/TRIAL SET

12

8325064

SetG
SetF
7_1
G

2

OBSERVATIONAL UNIT

13

8325064

SetG

SetF
7_2
G

2

OBSERVATIONAL UNIT

14

8325064

SetG

SetF

7_3
G

2

OBSERVATIONAL UNIT

15

8325064

Ames

SetR

R


1

EXPERIMENTAL UNIT/TRIAL SET

16

8325064

SetR
SetG
18_1
R

2

OBSERVATIONAL UNIT

17

8325064

SetR

SetG

18_2
R

2

OBSERVATIONAL UNIT

18

8325064

SetR
SetG
18_3
R

2

OBSERVATIONAL UNIT

8325064Ames
Dataset wrap
Name
gt
SetG
Rowcaps

R

Rows 1

TRIAL SET

16

8325064

Ames

SetR18_1R

2

OBSERVATIONAL UNIT

17

8325064

Ames

SetR18_2R

2

OBSERVATIONAL UNIT

18

8325064

Ames

SetR18_3R

2

OBSERVATIONAL UNIT

Dataset wrap
Namegt
-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
Rowcaps
Rows 1-5:Show the number of revertant colonies per plate collected for each of five observational units GTREFID=0_1 through 0_5 (see description in the relref dataset).
Rows 6, 7:Show summary values collected (MEAN, STANDARD DEVIATIONmean, standard deviation, fold increase) for GTREFID=A F that apply to the entire trial set, SetASetF, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID as shown in the relref RELREF dataset. 
Rows 817-1319:Revertent colonies were counted for each of three

Show 3 plates/observational units (GTREFID=

6

7_1 through

6

7_3)

and each value is associated with a record to show

where no revertant colonies were counted due to too much cytotoxicity and a postfix code of

"V" = "Very thin background bacterial lawn"
Rows 14-16:Show summary values collected (MEAN, STANDARD DEVIATION, and 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. 

"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 17-19:Show three 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 three 3 observational units (GTREFID=18_1 through 18_3).
Rows 23-25:Show summary values collected (MEANmean, STANDARD DEVIATION, and FOLD INCREASEstandard 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 RELREF dataset. 
Dataset2
RowSTUDYID
GNTXAID
DOMAINGTSEQGTREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRTGTSTRESCGTSTRESNGTSTRESUGTSTATGTREASNDGTMETHODGTDTC
18325064
Ames
GT1
0
1_1RPPRevertant Colony Numbers Per Plate26
NOT APPLICABLE


2626
NOT APPLICABLE




INSTRUMENT COUNTED

2015-08-03
28325064
Ames
GT2
0
1_2RPPRevertant Colony Numbers Per Plate35
NOT APPLICABLE


3535
NOT APPLICABLE



INSTRUMENT COUNTED2015-08-03
38325064
Ames
GT3
0
1_3RPPRevertant Colony Numbers Per Plate39
NOT APPLICABLE


3939
NOT APPLICABLE



INSTRUMENT COUNTED2015-08-03
48325064
Ames
GT4
0
1_4RPPRevertant Colony Numbers Per Plate35
NOT APPLICABLE


3535
NOT APPLICABLE



INSTRUMENT COUNTED

2015-08-03
58325064
Ames
GT5
0
1_5RPPRevertant Colony Numbers Per Plate30
NOT APPLICABLE


3030
NOT APPLICABLE



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

MEAN33.033.0
NOT APPLICABLE




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

STANDARD DEVIATION5.05.0
NOT APPLICABLE




2015-08-03
88325064
Ames
GT
1
86_1RPPRevertant Colony Numbers Per Plate8
NOT APPLICABLE


88
NOT APPLICABLE



MANUALLY COUNTED2015-08-03
98325064
Ames
GT
2
96_1CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
108325064
Ames
GT
3
106_2RPPRevertant Colony Numbers Per Plate10
NOT APPLICABLE


1010
NOT APPLICABLE



MANUALLY COUNTED2015-08-03
118325064
Ames
GT
4
116_2CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
128325064
Ames
GT
5
126_3RPPRevertant Colony Numbers Per Plate12
NOT APPLICABLE


1212
NOT APPLICABLE



MANUALLY COUNTED2015-08-03
138325064
Ames
GT
6
136_3CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
148325064
Ames
GT
7
14FRPPMEANMean Rev Colony Num Per Plate

10.0

NOT APPLICABLE


MEAN

10.0

10.0

NOT APPLICABLE




2015-08-03
158325064
Ames
GT
8
15FRPPSTDDVStd Dev Rev Colony Num Per Plate2.0
NOT APPLICABLE

STANDARD DEVIATION2.02.0
NOT APPLICABLE




2015-08-03
168325064
Ames
GT
9
16F
RPPFDINC
RPPFLDICFold Increase Rev Colony Num Per Plate0.3
NOT APPLICABLE

FOLD INCREASE0.30.3
NOT APPLICABLE




2015-08-03
178325064
Ames
GT
1
17
5
7_1CYTOTOXCytotoxicity

Toxic No Revertant Colonies



T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
188325064
Ames
GT
2
18
5
7_2CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
198325064
Ames
GT
3
19
5
7_3CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
208325064
Ames
GT
1
2018_1RPPRevertant Colony Numbers Per Plate

812

NOT APPLICABLE



812

812

NOT APPLICABLE



INSTRUMENT COUNTED

2015-08-03
218325064
Ames
GT
2
2118_2RPPRevertant Colony Numbers Per Plate

912

NOT APPLICABLE



912

912

NOT APPLICABLE



INSTRUMENT COUNTED2015-08-03
228325064
Ames
GT
3
2218_3RPPRevertant Colony Numbers Per Plate

839

NOT APPLICABLE



839

839

NOT APPLICABLE



INSTRUMENT COUNTED2015-08-03
238325064
Ames
GT
4
23RRPPMEANMean Rev Colony Num Per Plate854.3
NOT APPLICABLE

MEAN854.3854.3
NOT APPLICABLE




2015-08-03
248325064
Ames
GT
5
24RRPPSTDDVStd Dev Rev Colony Num Per Plate51.7
NOT APPLICABLE

STANDARD DEVIATION51.751.7
NOT APPLICABLE




2015-08-03
258325064
Ames
GT
6
25R
RPPFLDINC
RPPFLDICFold Increase Rev Colony Num Per Plate6.4
NOT APPLICABLE

FOLD INCREASE6.46.4
NOT APPLICABLE




2015-08-03