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Dataset wrap

Name	tx.xpt Trial Sets

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 913:	Shows the proper use of the LBSTAT variable LBUSCHFL 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.
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.

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title	tx.xpt (trial sets)

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET	TXSEQ

Expand

title	tx.xpt (trial sets)

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	Ames	TX	SetA	A-TA98-C0	1	SPECIES	Species	Salmonella typhimurium
2	8325064	Ames	TX	SetA	A-TA98-C0	2	STRAIN	Strain/Substrain	TA98
3	8325064	Ames	TX	SetA	A-TA98-C0	3	METACT	Metabolic Activation
4	8325064	Ames	TX	SetA	A-TA98-C0	4	METACTFL	Y/N presence of metabolic activation	N
5	8325064	Ames	TX	SetA	A-TA98-C0	5	TRTDMIN	Treatment Duration Minimum	71.5
6	8325064	Ames	TX	SetA	A-TA98-C0	6	TRTDTRG	Treatment Duration Target	72
7	8325064	Ames	TX	SetA	A-TA98-C0	7	TRTDMAX	Treatment Duration Maximum	72.5
8	8325064	Ames	TX	SetA	A-TA98-C0	8	TRTDU	Treatment Duration Unit	HOURS
9	8325064	Ames	TX	SetA	A-TA98-C0	9	INCBTMP	Incubation Temperature	37
10	8325064	Ames	TX	SetA	A-TA98-C0	10	INCBTMPU	Incubation Temperature Unit	C
11	8325064	Ames	TX	SetA	A-TA98-C0	11	HUMID	Atmospheric Relative Humidity Percent	50
12	8325064	Ames	TX	SetA	A-TA98-C0	12	ATMCO2	Atmospheric CO2 Percent	5
13	8325064	Ames	TX	SetA	A-TA98-C0	13	SPTOBID	Sponsor defined tobacco identifier	CIG01a
14	8325064	Ames	TX	SetA	A-TA98-C0	14	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
15	8325064	Ames	TX	SetA	A-TA98-C0	15	SAMTYP	Sample Type	Total Particulate Matter in PBS
16	8325064	Ames	TX	SetA	A-TA98-C0	16	INTRVN	name of the intervention article	TA1
17	8325064	Ames	TX	SetA	A-TA98-C0	17	ITVTYPE	type of intervention article	Vehicle Control
18	8325064	Ames	TX	SetA	A-TA98-C0	18	ITVCONC	Concentration of intervention article	0
19	8325064	Ames	TX	SetA	A-TA98-C0	19	ITVCONCU	Concentration Unit	ug/plate
20	8325064	Ames	TX	SetA	A-TA98-C0	20	TRTV	Treatment Vehicle	DMSO
21	8325064	Ames	TX	SetA	A-TA98-C0	21	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
22	8325064	Ames	TX	SetA	A-TA98-C0	22	DUREFID	Smoke Regimen	Medium Intensity Regimen
23	8325064	Ames	TX	SetF(row 6)	F-TA98-C500	1	SPECIES	Species
24	8325064	Ames	TX	SetF	F-TA98-C500	2	STRAIN	Strain/Substrain
25	8325064	Ames	TX	SetF	F-TA98-C500	3	METACT	Metabolic Activation
26	8325064	Ames	TX	SetF	F-TA98-C500	4	METACTFL	Y/N presence of metabolic activation	N
27	8325064	Ames	TX	SetF	F-TA98-C500		TRTDRTOL	Treatment Duration Tolerance
28	8325064	Ames	TX	SetF	F-TA98-C500		TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetF	F-TA98-C500		INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	TA1
	8325064	Ames	TX	SetF	F-TA98-C500		ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Product
	8325064	Ames	TX	SetF	F-TA98-C500		ITVCONC	Concentration of intervention article	500
	8325064	Ames	TX	SetF	F-TA98-C500		ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetF	F-TA98-C500		STRAIN	Strain/Substrain	TA98
	8325064	Ames	TX	SetF	F-TA98-C500		REGIME	Smoking Regime	ISO Regime
...













	8325064	Ames	TX	SetG (row 7) do G not I!!!			METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
	8325064	Ames	TX	SetG			TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)
	8325064	Ames	TX	SetG			TRTDRTOL	Treatment Duration Tolerance
	8325064	Ames	TX	SetG			TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetG			INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	2-Nitrofluorine
	8325064	Ames	TX	SetG			ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Positive Control
	8325064	Ames	TX	SetG			ITVCONC	Concentration of intervention article	5
	8325064	Ames	TX	SetG			ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetG			REGIME	Smoking Regime	ISO
...				SetG
	8325064	Ames	TX	SetR (Row 18)			METACT	Metabolic Activation (should there be two parms? Presence, type)?	None
	8325064	Ames	TX	SetR			TRTDRTRG	Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)	8325064	Ames	TX	SetR	TRTDRTOL	Treatment Duration Tolerance	8325064	Ames	TX	SetR	TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	8325064	Ames	TX	SetR	INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	4-Nitroquinoline-1-oxide	8325064	Ames	TX	SetR	ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Positive Control	8325064	Ames	TX	SetR	ITVCONC	Concentration of intervention article	2	8325064	Ames	TX	SetR	ITVCONCU	Concentration Unit	ug/plate	8325064	Ames	TX	SetR	STRAIN	Strain/Substrain	TA98	8325064	Ames	TX	SetR	REGIME	Smoking Regime	ISO	, one text field not-analyzable)
	8325064	Ames	TX	SetR			TRTDRTOL	Treatment Duration Tolerance
	8325064	Ames	TX	SetR			TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)
	8325064	Ames	TX	SetR			INTRVN	name of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	4-Nitroquinoline-1-oxide
	8325064	Ames	TX	SetR			ITVTYPE	type of intervention article choices of values: product; negative control; positive control	Positive Control
	8325064	Ames	TX	SetR			ITVCONC	Concentration of intervention article	2
	8325064	Ames	TX	SetR			ITVCONCU	Concentration Unit	ug/plate
	8325064	Ames	TX	SetR			STRAIN	Strain/Substrain	TA98
	8325064	Ames	TX	SetR			REGIME	Smoking Regime	ISO

OBUID in this example is defined by the sponsor by the location on one of multiple exposure/incubation plates.

Dataset wrap

Name	ou.xpt Observational and Experimental Unit Identifiers

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.)

Rowcaps

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:	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.
Rows 9-11:	Shows the values of 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.
Row 12-14:	Shows the values of 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.

Dataset wrap

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

Row	STUDYID	ASSAYID	DOMAIN	SETCD	EUID	OBUID
1	8325064	Ames	OU	SetA	A	0_1
2	8325064	Ames	OU	SetA	A	0_2
3	8325064	Ames	OU	SetA	A	0_3
4	8325064	Ames	OU	SetA	A	0_4
5	8325064	Ames	OU	SetA	A	0_5
6	8325064	Ames	OU	SetF	F	6_1
7	8325064	Ames	OU	SetF	F	6_2
8	8325064	Ames	OU	SetF	F	6_3
9	8325064	Ames	OU	SetG	G	7_1
10	8325064	Ames	OU	SetG	G	7_2
11	8325064	Ames	OU	SetG	G	7_3
12	8325064	Ames	OU	SetR	R	18_1
13	8325064	Ames	OU	SetR	R	18_2
14	8325064	Ames	OU	SetR	R	18_3

Dataset wrap

Name	ou.xpt Observational and Experimental Unit Identifiers

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.)

Rowcaps

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:

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.

Rows 9-11:

Shows the values of 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.

Row 12-14:

Shows the values of 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:

Dataset2

Row	STUDYID	ASSAYID	DOMAIN	SETCD	EUID	OBUID
1	8325064	Ames	OU	SetA	A	0_1
2	8325064	Ames	OU	SetA	A	0_2
3	8325064	Ames	OU	SetA	A	0_3
4	8325064	Ames	OU	SetA	A	0_4
5	8325064	Ames	OU	SetA	A	0_5
6	8325064	Ames	OU	SetF	F	6_1
7	8325064	Ames	OU	SetF	F	6_2
8	8325064	Ames	OU	SetF	F	6_3
9	8325064	Ames	OU	SetG	G	7_1
10	8325064	Ames	OU	SetG	G	7_2
11	8325064	Ames	OU	SetG	G	7_3
12	8325064	Ames	OU	SetR	R	18_1
13	8325064	Ames	OU	SetR	R	18_2
14	8325064	Ames	OU	SetR	R	18_3

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