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changes.mady.by.user Lou Ann Kramer

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  • How do we handle "toxic, no revertant colonies"?  (LAK will add 6 records with GTSTAT = NOT DONE, GTREASND = "TOO MUCH CYTOTOXICITY,"
  • When "-" in Mean, Std Dev, Fold Inc - refer to SEND team's marked-up table (GTSTAT = NOT DONE; variety of REASND)
  1. populate units of COLONIES
  2. recreate the data table - clean up, add "S" to the first set A
  3. move assumptions out of all of the
  4. populate units of COLONIES
  5. recreate the data table - clean up, add "S" to the first set A
  6. move assumptions out of all of the examples
  7. add row captions to highlight exceptions/assumptions

...

Dataset wrap
Nametx.xpt Trial Sets
Rowcaps
Rows 1-22:Shows trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the first row of the raw data table, see the row labeled "SetA" in the table, Raw Data for Study 8325064.
Rows 2-4:Show two records for Alkaline Phosphatase that were collected 1 day apart and are
  • How do we handle "toxic, no revertant colonies"?  (LAK will add 6 records with GTSTAT = NOT DONE, GTREASND = "TOO MUCH CYTOTOXICITY,"
  • When "-" in Mean, Std Dev, Fold Inc - refer to SEND team's marked-up table (GTSTAT = NOT DONE; variety of REASND)
Rowcaps
Rows 1-22:Shows trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the first row of the raw data table, see the row labeled "SetA" in the table, Raw Data for Study 8325064.
Rows 2-4:Show two records for Alkaline Phosphatase that were collected 1 day apart and are expected to be reported together. Row 4 shows how to create a derived record (average of the Rows 2 and 3) and flag it as Derived (LBDRVFL = "Y") as well as the record to use as baseline (LBBLFL = "Y").
Rows 6-7:Show a suggested use of the LBSCAT variable. It could be used to further classify types of tests within a laboratory panel (e.g., "DIFFERENTIAL").
Row 13:Shows the use of LBUSCHFL to indicate that the test result was obtained from an unscheduled blood collection. In this case, the subject was moribund and a blood sample was taken prior to sacrifice.
Rows 1, 6:Use records in the SUPPLB dataset example to show biological significance assigned by the investigator for test results.

...

Dataset wrap
Nameou.xpt Observational and Experimental Unit Identifiers
Dataset wrap
Rowcaps

NOTE: Observational Unit Identifiers (OBUIDs) are defined by the sponsor to uniquely identify the observational unit within an experimental unit. In this example OBUIDs are defined by the sponsor based on the test conditions (trial set) and the unit's location on one of multiple exposure/incubation plates.

Rows 1-5:Show the values for OBUID within the experimental unit identifier for Set A, as defined in the trial set dataset.
Rows 6-8:Show the values for OBUID within the experimental unit identifier for Set F, as defined in the trial set dataset

Experimental unit - The unit to which the treatment is applied, eg. Test tube

Observational unit - The unit on which the response is measured. (This may not be the same as the experimental unit.)

Shows the values of the experimental unit identifiers and associated observational unit identifiers for the set, SetF.
SetF is the sixth row of the raw data table, see the row labeled "SetF" in the table, Raw Data for Study 8325064
Rowcaps
Dataset wrap
Rows 1-5:Shows the values of the experimental unit identifiers and associated observational unit identifiers for the set, SetA.
SetA is the first row of the raw data table, see the row labeled "SetA" in the table, Raw Data for Study 8325064.
Rows 6-8:
.
Rows 9-11:
Shows
Show the values
of
for OBUID within the experimental unit
identifiers and associated observational unit identifiers for the set, SetG.
SetG is the seventh row of the raw data table, see the row labeled "SetG" in the table, Raw Data for Study 8325064
identifier for Set G, as defined in the trial set dataset.
Row 12-14:
Shows
Show the values
of
for OBUID within the experimental unit
identifiers and associated observational unit identifiers for the set, SetR.
SetR is the eighteenth row of the raw data table, see the row labeled "SetR" in the table, Raw Data for Study 8325064.		Rows 2-4:Rows 1, 6:

Observational Unit Identifiers (OBUIDs) are defined by the sponsor to uniquely identify the observational unit within an experimental unit. In this example OBUIDs are defined by the sponsor based on the test conditions (trial set) and the unit's location on one of multiple exposure/incubation plates.

18_3
Rowcaps
Rows 1-5:Show the values for OBUID within the experimental unit identifier for Set A, as defined in the trial set dataset.
Rows 6-8:Show the values for OBUID within the experimental unit identifier for Set F, as defined in the trial set dataset.
Rows 9-11:Show the values for OBUID within the experimental unit identifier for Set G, as defined in the trial set dataset.
Row 12-14:Show the values for OBUID within the experimental unit identifier for Set R, as defined in the trial set dataset.
Dataset2
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
identifier for Set R, as defined in the trial set dataset.
Dataset2
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
titlegt.xpt (similar to LB)
Dataset wrap
Namegt.xpt
Rowcaps
Rows 1-7:Show values collected for the set, SetA. 
Rows 8-15:Shows values collected for the set, SetF.  
Rows 6-7:Show a suggested use of the LBSCAT variable. It could be used to further classify types of tests within a laboratory panel (e.g., "DIFFERENTIAL").
Rows 6,7,12,13, x,x,x,x:Show values collected (e.g., MEAN, STANDARD DEVIATION, and/or FOLD INCREASE) that apply to all of the observational units within the experimental unit, as show by OBUID = "ALL". 
Row 9:Shows the proper use of the LBSTAT variable to indicate "NOT DONE," when the fact that the test was done was documented.
Row 12:The subject had Cholesterol measured. The normal range for this test is <200 mg/dL. The value <200 may not be used in the normal range variables LBORNRHI or LBSTNRHI; however, a sponsor may decide, e.g., to enter "0" into LBORNRLO and "199" in LBORNRHI. The sponsor must define the appropriate value for all of the normal range variables.
Row 13:Shows the use of LBUSCHFL to indicate that the test result was obtained from an unscheduled blood collection. In this case, the subject was moribund and a blood sample was taken prior to sacrifice.
Rows 1, 6:Use records in the SUPPLB dataset example to show biological significance assigned by the investigator for test results.
Expand
titleRaw Data Table for Study 8325064

Dataset2
RowSTUDYIDASSAYIDDOMAINTXSETCDEUIDOUIDGTSEQGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRT (coll. summ. result type)GTSTRESCGTSTRESNGTSTRESUGTDTCGTMETHOD
18325064AmesGTSETA A0_11RPPRevertant Numbers Per Plate26COLONIES
2626COLONIES
2015-08-03

INSTRUMENT COUNTED

28325064AmesGTSETA A0_22RPPRevertant Numbers Per Plate35COLONIES
3535

2015-08-03		INSTRUMENT COUNTED
38325064AmesGTSETA A0_33RPPRevertant Numbers Per Plate39COLONIES
3939

2015-08-03		INSTRUMENT COUNTED
48325064AmesGTSETA A0_44RPPRevertant Numbers Per Plate35COLONIES
3535

2015-08-03

INSTRUMENT COUNTED

58325064AmesGTSETA A0_55RPPRevertant Numbers Per Plate30COLONIES
3030
2015-08-03INSTRUMENT COUNTED
68325064AmesGTSETA AALL6RPPRevertant Numbers Per Plate33.0COLONIESMEAN33.033.0


78325064AmesGTSETA AALL7RPPRevertant Numbers Per Plate5.0COLONIESSTANDARD DEVIATION5.05.0


88325064AmesGTSETFF6_11RPPRevertant Numbers Per Plate8COLONIES
88

MANUALLY COUNTED
98325064AmesGTSETFF6_12CYTOTOXCytotoxicityVery thin background bacterial lawnCOLONIES
V



108325064AmesGTSETF F6_23RPPRevertant Numbers Per Plate10COLONIES
1010

MANUALLY COUNTED
118325064AmesGTSETF F6_34RPPRevertant Numbers Per Plate12COLONIES
1212

MANUALLY COUNTED
128325064AmesGTSETFFALL5RPPMEANMean of Revertant Numbers Per Plate

10.0


COLONIESMEAN

10.0


10.0





138325064AmesGTSETF FALL6RPPSTDDVStandard Deviation of Revertant Numbers Per Plate2.0COLONIESSTANDARD DEVIATION2.02.0


148325064AmesGTSETF FALL7RPPFDINCFold Increase of Revertant Numbers Per Plate0.3COLONIESFOLD INCREASE0.30.3



8325064AmesGTSETGG5_11RPPRevertant Numbers Per Plate1104

11041104



8325064AmesGTSETGG5_22RPPRevertant Numbers Per Plate1037

10371037



8325064AmesGTSETGG5_33RPPRevertant Numbers Per Plate971

971971



8325064AmesGTSETRRALL
RPPMEANMean of Revertant Numbers Per Plate

1037.3




1037.3


1037.3






8325064AmesGTSETRRALL
RPPSTDDVStandard Deviation of Revertant Numbers Per Plate66.5

66.566.5



8325064AmesGTSETRRALL
RPPFLDINCFold Increase of Revertant Numbers Per Plate31.4

31.431.4