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Dataset wrap
Nametx.xpt Trial Sets
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., 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 SetR. SetR is the data for the vehicle control (i.e., Strain of TA100, positive control with a concentration value of 2). SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
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

Submerged
158325064AmesTXSetAA-TA98-C015SAMTYP

Sample Type

Total Particulate Matter in PBS
168325064AmesTXSetAA-TA98-C016INTRVN

name of the intervention article

TA1
178325064AmesTXSetAA-TA98-C017ITVTYPE

type of intervention article

Vehicle Control
188325064AmesTXSetAA-TA98-C018ITVCONCConcentration of intervention article0
198325064AmesTXSetAA-TA98-C019ITVCONCUConcentration Unitug/plate
208325064AmesTXSetAA-TA98-C020TRTVTreatment VehicleDMSO
218325064AmesTXSetAA-TA98-C021SPDEVIDSponsor defined device identifierPUFFMASTER3K
228325064AmesTXSetAA-TA98-C022DUREFIDSmoke RegimenMedium Intensity Regimen
238325064AmesTX

SetR

R-TA100-C21SPECIESSpeciesSalmonella typhimurium
248325064AmesTX

SetR

R-TA100-C22STRAINStrain/SubstrainTA100
258325064AmesTX

SetR

R-TA100-C23METACTMetabolic Activation
268325064AmesTX

SetR

R-TA100-C24METACTFLY/N presence of metabolic activationN
278325064AmesTX

SetR

R-TA100-C25TRTDMINTreatment Duration Minimum71.5
288325064AmesTX

SetR

R-TA100-C26TRTDTRGTreatment Duration Target72
298325064AmesTX

SetR

R-TA100-C27TRTDMAXTreatment Duration Maximum72.5
308325064AmesTX

SetR

R-TA100-C28TRTDUTreatment Duration UnitHOURS
318325064AmesTX

SetR

R-TA100-C29INCBTMPIncubation Temperature37
328325064AmesTX

SetR

R-TA100-C210INCBTMPUIncubation Temperature UnitC
338325064AmesTX

SetR

R-TA100-C211HUMIDAtmospheric Relative Humidity Percent50
348325064AmesTX

SetR

R-TA100-C212ATMCO2Atmospheric CO2 Percent5
358325064AmesTX

SetR

R-TA100-C213SPTOBID

Sponsor defined tobacco identifier

CIG01a
368325064AmesTX

SetR

R-TA100-C214EXPTYP

Exposure Type

Submerged
378325064AmesTX

SetR

R-TA100-C215SAMTYP

Sample Type

Total Particulate Matter in PBS
388325064AmesTX

SetR

R-TA100-C216INTRVN

name of the intervention article

TA1
398325064AmesTX

SetR

R-TA100-C217ITVTYPE

type of intervention article

Positive Control
408325064AmesTX

SetR

R-TA100-C218ITVCONCConcentration of intervention article2
418325064AmesTX

SetR

R-TA100-C219ITVCONCUConcentration Unitug/plate
428325064AmesTX

SetR

R-TA100-C220TRTVTreatment VehicleDMSO
438325064AmesTX

SetR

R-TA100-C221SPDEVIDSponsor defined device identifierPUFFMASTER3K
448325064AmesTX

SetR

R-TA100-C222DUREFIDSmoke RegimenMedium Intensity Regimen

...

REFID values are defined by the

...

applicant to uniquely identify the observational unit within an experimental unit.  In

...

the simplified picture of an assay (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 example study, 8325064.   

Image Added


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).

Dataset wrap
Namerelref.xpt
Rowcaps
Rows 1-5
Dataset wrap
Nameou.xpt Observational and Experimentat Unit Identifiers
Rowcaps
Rows 1-5:Show the values for OBUID within the experimental unit identifier, A, for Set A, as defined in the trial set dataset.
Rows 6-8:Show the values for OBUID within the experimental unit identifier, FA, for Set FA, as defined in the trial set dataset.
Rows 96-118:Show the values for OBUID within the experimental unit identifier, GF, for Set F, as defined in the trial set dataset.
Rows 9-11:Show the values for OBUID within the experimental unit identifier, G, for Set G, as defined in the trial set dataset.
Rows 12-14:Show the values for OBUID within the experimental unit identifier, R,  for Set R, as defined in the trial set dataset.
Rows 12-14:Show the values for OBUID within the experimental unit identifier, R,  for Set R, as defined in the trial set dataset.
set dataset.

For study 8325064, the applicant chose to define the REFIDs at the trial set level  on trial sets (e.g., A, F, G, and R) and  based on the position of the tube in one of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).



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).



18_3
Dataset2
tableidrelref.xpt

Row

STUDYID

ASSAYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

8325064

Ames

SetA

A


1

TRIAL SET

2

8325064

Ames

SetA

0_1

A

2

OBSERVATIONAL UNIT

3

8325064

Ames

SetA

0_2

A

2

OBSERVATIONAL UNIT

4

8325064

Ames

SetA

0_3

A

2

OBSERVATIONAL UNIT

5

8325064

Ames

SetA

0_4

A

2

OBSERVATIONAL UNIT

6

8325064

Ames

SetA

0_5

A

2

OBSERVATIONAL UNIT

7

8325064

Ames

SetF

F


1

TRIAL SET

8

8325064

Ames

SetF6_1F

2

OBSERVATIONAL UNIT

9

8325064

Ames

SetF6_2F

2

OBSERVATIONAL UNIT

10

8325064

Ames

SetF

6_3F

2

OBSERVATIONAL UNIT

11

8325064

Ames

SetG

G


1

TRIAL SET

12

8325064

Ames

SetG7_1G

2

OBSERVATIONAL UNIT

13

8325064

Ames

SetG

7_2G

2

OBSERVATIONAL UNIT

14

8325064

Ames

SetG7_3G

2

OBSERVATIONAL UNIT

15

8325064

Ames

SetG

R


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

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
148325064AmesOUSetRR



Dataset wrap
Namegt.xpt
Rowcaps
Rows 1-7:Show values collected for the set, SetA. 
Rows 8-16:Show 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:Show 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:Show values collected for the set, SetR.  
Rows 6-7, 14-16, 23-25:Show summary values collected (e.g., MEAN, STANDARD DEVIATION, and/or FOLD INCREASE) that apply to all of the observational units and the entire experimental unit, as shown by OBUID = "ALL" and EUID = "ALL".
Dataset2
RowSTUDYIDASSAYIDDOMAINTXSETCDEUIDOUIDGTSEQGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRT (coll. summ. result type)GTSTRESCGTSTRESNGTSTRESUGTSTATGTREASNDGTMETHODGTDTC
18325064AmesGTSETAA0_11RPPRevertant Numbers Per Plate26COLONIES
2626COLONIES

INSTRUMENT COUNTED

2015-08-03
28325064AmesGTSETAA0_22RPPRevertant Numbers Per Plate35COLONIES
3535COLONIES

INSTRUMENT COUNTED2015-08-03
38325064AmesGTSETAA0_33RPPRevertant Numbers Per Plate39COLONIES
3939COLONIES

INSTRUMENT COUNTED2015-08-03
48325064AmesGTSETAA0_44RPPRevertant Numbers Per Plate35COLONIES
3535COLONIES

INSTRUMENT COUNTED

2015-08-03
58325064AmesGTSETAA0_55RPPRevertant Numbers Per Plate30COLONIES
3030COLONIES

INSTRUMENT COUNTED2015-08-03
68325064AmesGTSETAAALL6RPPRevertant Numbers Per Plate33.0COLONIESMEAN33.033.0COLONIES


2015-08-03
78325064AmesGTSETAAALL7RPPRevertant Numbers Per Plate5.0COLONIESSTANDARD DEVIATION5.05.0COLONIES


2015-08-03
88325064AmesGTSETFF6_11RPPRevertant Numbers Per Plate8COLONIES
88COLONIES

MANUALLY COUNTED2015-08-03
98325064AmesGTSETFF6_12CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
108325064AmesGTSETFF6_23RPPRevertant Numbers Per Plate10COLONIES
1010COLONIES

MANUALLY COUNTED2015-08-03
118325064AmesGTSETFF6_22CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
128325064AmesGTSETFF6_34RPPRevertant Numbers Per Plate12COLONIES
1212COLONIES

MANUALLY COUNTED2015-08-03
138325064AmesGTSETFF6_32CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
148325064AmesGTSETFALLALL5RPPMEANMean of Revertant Numbers Per Plate

10.0

COLONIESMEAN

10.0

10.0

COLONIES


2015-08-03
158325064AmesGTSETFALLALL6RPPSTDDVStandard Deviation of Revertant Numbers Per Plate2.0COLONIESSTANDARD DEVIATION2.02.0COLONIES


2015-08-03
168325064AmesGTSETFALLALL7RPPFDINCFold Increase of Revertant Numbers Per Plate0.3COLONIESFOLD INCREASE0.30.3COLONIES


2015-08-03
178325064AmesGTSETGG5_11CYTOTOXCytotoxicity

Toxic No Revertant Colonies



T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
188325064AmesGTSETGG5_22CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
198325064AmesGTSETGG5_33CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
208325064AmesGTSETRR18_11RPPRevertant Numbers Per Plate

812

COLONIES


812

812

COLONIES

INSTRUMENT COUNTED

2015-08-03
218325064AmesGTSETRR18_22RPPRevertant Numbers Per Plate

912

COLONIES


912

912

COLONIES

INSTRUMENT COUNTED2015-08-03
228325064AmesGTSETRR18_33RPPRevertant Numbers Per Plate

839

COLONIES


839

839

COLONIES

INSTRUMENT COUNTED2015-08-03
238325064AmesGTSETRRALL4RPPMEANMean of Revertant Numbers Per Plate854.3COLONIESMEAN854.3854.3COLONIES


2015-08-03
248325064AmesGTSETRRALL5RPPSTDDVStandard Deviation of Revertant Numbers Per Plate51.7COLONIESSTANDARD DEVIATION51.751.7COLONIES


2015-08-03
258325064AmesGTSETRRALL6RPPFLDINCFold Increase of Revertant Numbers Per Plate6.4COLONIESFOLD INCREASE6.46.4COLONIES


2015-08-03