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Dataset wrap

Name	tx.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 first row of the raw data table, see the row 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 223-4:	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.
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Rows 6-7:
Row 13:
Rows 1, 6:

Dataset2

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
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Dataset2

2TA98-C0AC0SAMTYP AC0TRTV VehicleDMSO2TA98...

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	Ames	TX	SetA	A-TA98-C0	111	SPECIES	Species	Salmonella typhimurium	HUMID	Atmospheric Relative Humidity Percent	50
122	8325064	Ames	TX	SetA	A-TA98-C0	12	STRAIN	Strain/Substrain	TA98	ATMCO2	Atmospheric CO2 Percent	5
133	8325064	Ames	TX	SetA SetA	A-TA98-C0	3	METACT	Metabolic Activation	13	SPTOBID	Sponsor defined tobacco identifier	CIG01a
144	8325064	Ames	TX	SetA SetA	A-	4	METACTFL	TA98-C0	14	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
15	Y/N presence of metabolic activation	N	5	8325064	Ames	TX	SetA	A-TA98-C0	515	SAMTYP	Sample Type	Total Particulate Matter in PBS
16	TRTDMIN	Treatment Duration Minimum	71.5	6	8325064	Ames	TX	SetA	A-TA98-C0	616	TRTDTRG	INTRVN	name of the intervention article	TA1
17	Treatment Duration Target	72	7	8325064	Ames	TX	SetA	A-TA98-C0	717	TRTDMAX	Treatment Duration Maximum	ITVTYPE	type of intervention article	Vehicle Control
18	72.5	8	8325064	Ames	TX	SetA	A-TA98-C0	818	TRTDU	Treatment Duration Unit	ITVCONC	Concentration of intervention article	0
19	HOURS	9	8325064	Ames	TX	SetA	A-TA98-C0	919	INCBTMPITVCONCU	Incubation Temperature	37	Concentration Unit	ug/plate
2010	8325064	Ames	TX	SetA	A-TA98-C0	1020	INCBTMPU	Incubation Temperature Unit	C	TRTV	Treatment Vehicle	DMSO
2111	8325064	Ames	TX	SetA	A-TA98-C0	1121	HUMID	Atmospheric Relative Humidity Percent	50	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
2212	8325064	Ames	TX	SetA	A-TA98-C0	1222	ATMCO2	Atmospheric CO2 Percent	5	DUREFID	Smoke Regimen	Medium Intensity Regimen
2313	8325064	Ames	TX	SetA SetF	AF-TA98-C0C500	131	SPTOBID	Sponsor defined tobacco identifier	CIG01a	SPECIES	Species	Salmonella typhimurium
2414	8325064	Ames	TX	SetA SetF	F-TA98-	C50014	2	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged	STRAIN	Strain/Substrain	TA98
2515	8325064	Ames	TX	SetA SetF	AF-TA98-C0C500	153	METACT	Sample Type	Total Particulate Matter in PBS	Metabolic Activation
2616	8325064	Ames	TX	SetA SetF	AF-TA98-C0C500	164	INTRVN	name of the intervention article	TA1	METACTFL	Y/N presence of metabolic activation	N
2717	8325064	Ames	TX	SetASetF	AF-TA98-C0C500	175	ITVTYPE	type of intervention article	Vehicle Control	TRTDMIN	Treatment Duration Minimum	71.5
2818	8325064	Ames	TX	SetASetF	AF-TA98-C0C500	186	ITVCONC	Concentration of intervention article	0	TRTDTRG	Treatment Duration Target	72
2919	8325064	Ames	TX	SetASetF	F-TA98-	C500	197	ITVCONCU	Concentration Unit	ug/plate	TRTDMAX	Treatment Duration Maximum	72.5
3020	8325064	Ames	TX	SetASetF	AF-TA98-C0C500	208	TRTDU	Treatment	Duration Unit	HOURS
2131	8325064	Ames	TX	SetASetF	AF-TA98-C0C500	219	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K	INCBTMP	Incubation Temperature	37
3222	8325064	Ames	TX	SetASetF	AF-TA98-C0C500	2210	DUREFID	Smoke Regimen	Medium Intensity Regimen	INCBTMPU	Incubation Temperature Unit	C
3323	8325064	Ames	TX	SetF	F-TA98-C500	11	1	SPECIES	Species	HUMID	Atmospheric Relative Humidity Percent	50
3424	8325064	Ames	TX	SetF	F-TA98-C500	12	ATMCO2	STRAIN	Strain/Substrain	Atmospheric CO2 Percent	5
3525	8325064	Ames	TX	SetF	F-TA98-C500	3	METACT	Metabolic Activation	13	SPTOBID	Sponsor defined tobacco identifier	CIG01a
3626	8325064	Ames	TX	SetF	F-TA98-C500	414	METACTFL	EXPTYP	Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)	Submerged
37	Y/N presence of metabolic activation	N	27	8325064	Ames	TX	SetF	F-TA98-C500	15	SAMTYP	Sample Type	Total Particulate Matter in PBS
38	TRTDRTOL	Treatment Duration Tolerance	28	8325064	Ames	TX	SetF	F-TA98-C500	TRTDURU		16	INTRVN	name of the intervention article	TA1
39Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	8325064	Ames	TX	SetF	F-TA98-C500	17	INTRVNITVTYPE	name type of the intervention article (Tobacco ProdA, Bleomycin or Cyclophosphamid A)	Vehicle Control
40TA1	8325064	Ames	TX	SetF	F-TA98-C500	18	ITVTYPEITVCONC	type Concentration of intervention article choices of values: product; negative control; positive control	0
41Product	8325064	Ames	TX	SetF	F-TA98-C500	19	ITVCONCITVCONCU	Concentration of intervention articleUnit	ug/plate
42500	8325064	Ames	TX	SetF	F-TA98-C500		20	TRTV	Treatment Vehicle	DMSO
43	ITVCONCU	Concentration Unit	ug/plate	8325064	Ames	TX	SetF	F-TA98-C500	STRAIN	Strain/Substrain		21	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
44		8325064	Ames	TX	SetF	F-TA98-C500	REGIME	Smoking Regime	ISO Regime		22	DUREFID	Smoke Regimen	Medium Intensity Regimen
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	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

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