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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 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

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	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	SetR	R-TA100-C2	1	SPECIES	Species	Salmonella typhimurium
24	8325064	Ames	TX	SetR	R-TA100-C2	2	STRAIN	Strain/Substrain	TA100
25	8325064	Ames	TX	SetR	R-TA100-C2	3	METACT	Metabolic Activation
26	8325064	Ames	TX	SetR	R-TA100-C2	4	METACTFL	Y/N presence of metabolic activation	N
27	8325064	Ames	TX	SetR	R-TA100-C2	5	TRTDMIN	Treatment Duration Minimum	71.5
28	8325064	Ames	TX	SetR	R-TA100-C2	6	TRTDTRG	Treatment Duration Target	72
29	8325064	Ames	TX	SetR	R-TA100-C2	7	TRTDMAX	Treatment Duration Maximum	72.5
30	8325064	Ames	TX	SetR	R-TA100-C2	8	TRTDU	Treatment Duration Unit	HOURS
31	8325064	Ames	TX	SetR	R-TA100-C2	9	INCBTMP	Incubation Temperature	37
32	8325064	Ames	TX	SetR	R-TA100-C2	10	INCBTMPU	Incubation Temperature Unit	C
33	8325064	Ames	TX	SetR	R-TA100-C2	11	HUMID	Atmospheric Relative Humidity Percent	50
34	8325064	Ames	TX	SetR	R-TA100-C2	12	ATMCO2	Atmospheric CO2 Percent	5
35	8325064	Ames	TX	SetR	R-TA100-C2	13	SPTOBID	Sponsor defined tobacco identifier	CIG01a
36	8325064	Ames	TX	SetR	R-TA100-C2	14	EXPTYP	Exposure Type	Submerged
37	8325064	Ames	TX	SetR	R-TA100-C2	15	SAMTYP	Sample Type	Total Particulate Matter in PBS
38	8325064	Ames	TX	SetR	R-TA100-C2	16	INTRVN	name of the intervention article	TA1
39	8325064	Ames	TX	SetR	R-TA100-C2	17	ITVTYPE	type of intervention article	Positive Control
40	8325064	Ames	TX	SetR	R-TA100-C2	18	ITVCONC	Concentration of intervention article	2
41	8325064	Ames	TX	SetR	R-TA100-C2	19	ITVCONCU	Concentration Unit	ug/plate
42	8325064	Ames	TX	SetR	R-TA100-C2	20	TRTV	Treatment Vehicle	DMSO
43	8325064	Ames	TX	SetR	R-TA100-C2	21	SPDEVID	Sponsor defined device identifier	PUFFMASTER3K
44	8325064	Ames	TX	SetR	R-TA100-C2	22	DUREFID	Smoke Regimen	Medium 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 Modified

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

Name	gt.xpt

Rowcaps

Rows 1-7:	Show values collected for the trial set, SetA.
Rows 8-16:	Show values collected for the trial 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 trial 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 trial 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 the entire trial set, as indicated by the LVLDESC=TRIAL SET for these REFID values in the relref dataset.

Dataset2

Row	STUDYID	ASSAYID	DOMAIN	GTSEQ	REFID	GTTESTCD	GTTEST	GTORRES	GTORRESU	GTCOLSRT	GTSTRESC	GTSTRESN	GTSTRESU	GTSTAT	GTREASND	GTMETHOD	GTDTC
1	8325064	Ames	GT	1	0_1	RPP	Revertant Numbers Per Plate	26	COLONIES		26	26	COLONIES			INSTRUMENT COUNTED	2015-08-03
2	8325064	Ames	GT	2	0_2	RPP	Revertant Numbers Per Plate	35	COLONIES		35	35	COLONIES			INSTRUMENT COUNTED	2015-08-03
3	8325064	Ames	GT	3	0_3	RPP	Revertant Numbers Per Plate	39	COLONIES		39	39	COLONIES			INSTRUMENT COUNTED	2015-08-03
4	8325064	Ames	GT	4	0_4	RPP	Revertant Numbers Per Plate	35	COLONIES		35	35	COLONIES			INSTRUMENT COUNTED	2015-08-03
5	8325064	Ames	GT	5	0_5	RPP	Revertant Numbers Per Plate	30	COLONIES		30	30	COLONIES			INSTRUMENT COUNTED	2015-08-03
6	8325064	Ames	GT	6	A	RPP	Revertant Numbers Per Plate	33.0	COLONIES	MEAN	33.0	33.0	COLONIES				2015-08-03
7	8325064	Ames	GT	7	A	RPP	Revertant Numbers Per Plate	5.0	COLONIES	STANDARD DEVIATION	5.0	5.0	COLONIES				2015-08-03
8	8325064	Ames	GT	1	6_1	RPP	Revertant Numbers Per Plate	8	COLONIES		8	8	COLONIES			MANUALLY COUNTED	2015-08-03
9	8325064	Ames	GT	2	6_1	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
10	8325064	Ames	GT	3	6_2	RPP	Revertant Numbers Per Plate	10	COLONIES		10	10	COLONIES			MANUALLY COUNTED	2015-08-03
11	8325064	Ames	GT	4	6_2	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
12	8325064	Ames	GT	5	6_3	RPP	Revertant Numbers Per Plate	12	COLONIES		12	12	COLONIES			MANUALLY COUNTED	2015-08-03
13	8325064	Ames	GT	6	6_3	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
14	8325064	Ames	GT	7	F	RPPMEAN	Mean of Revertant Numbers Per Plate	10.0	COLONIES	MEAN	10.0	10.0	COLONIES				2015-08-03
15	8325064	Ames	GT	8	F	RPPSTDDV	Standard Deviation of Revertant Numbers Per Plate	2.0	COLONIES	STANDARD DEVIATION	2.0	2.0	COLONIES				2015-08-03
16	8325064	Ames	GT	9	F	RPPFDINC	Fold Increase of Revertant Numbers Per Plate	0.3	COLONIES	FOLD INCREASE	0.3	0.3	COLONIES				2015-08-03
17	8325064	Ames	GT	1	5_1	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
18	8325064	Ames	GT	2	5_2	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
19	8325064	Ames	GT	3	5_3	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
20	8325064	Ames	GT	1	18_1	RPP	Revertant Numbers Per Plate	812	COLONIES		812	812	COLONIES			INSTRUMENT COUNTED	2015-08-03
21	8325064	Ames	GT	2	18_2	RPP	Revertant Numbers Per Plate	912	COLONIES		912	912	COLONIES			INSTRUMENT COUNTED	2015-08-03
22	8325064	Ames	GT	3	18_3	RPP	Revertant Numbers Per Plate	839	COLONIES		839	839	COLONIES			INSTRUMENT COUNTED	2015-08-03
23	8325064	Ames	GT	4	R	RPPMEAN	Mean of Revertant Numbers Per Plate	854.3	COLONIES	MEAN	854.3	854.3	COLONIES				2015-08-03
24	8325064	Ames	GT	5	R	RPPSTDDV	Standard Deviation of Revertant Numbers Per Plate	51.7	COLONIES	STANDARD DEVIATION	51.7	51.7	COLONIES				2015-08-03
25	8325064	Ames	GT	6	R	RPPFLDINC	Fold Increase of Revertant Numbers Per Plate	6.4	COLONIES	FOLD INCREASE	6.4	6.4	COLONIES				2015-08-03

Dataset wrap

Name	gt.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

Row	STUDYID	ASSAYID	DOMAIN	TXSETCD	EUID	OUID	GTSEQ	GTTESTCD	GTTEST	GTORRES	GTORRESU	GTCOLSRT (coll. summ. result type)	GTSTRESC	GTSTRESN	GTSTRESU	GTSTAT	GTREASND	GTMETHOD	GTDTC
1	8325064	Ames	GT	SETA	A	0_1	1	RPP	Revertant Numbers Per Plate	26	COLONIES		26	26	COLONIES			INSTRUMENT COUNTED	2015-08-03
2	8325064	Ames	GT	SETA	A	0_2	2	RPP	Revertant Numbers Per Plate	35	COLONIES		35	35	COLONIES			INSTRUMENT COUNTED	2015-08-03
3	8325064	Ames	GT	SETA	A	0_3	3	RPP	Revertant Numbers Per Plate	39	COLONIES		39	39	COLONIES			INSTRUMENT COUNTED	2015-08-03
4	8325064	Ames	GT	SETA	A	0_4	4	RPP	Revertant Numbers Per Plate	35	COLONIES		35	35	COLONIES			INSTRUMENT COUNTED	2015-08-03
5	8325064	Ames	GT	SETA	A	0_5	5	RPP	Revertant Numbers Per Plate	30	COLONIES		30	30	COLONIES			INSTRUMENT COUNTED	2015-08-03
6	8325064	Ames	GT	SETA	A	ALL	6	RPP	Revertant Numbers Per Plate	33.0	COLONIES	MEAN	33.0	33.0	COLONIES				2015-08-03
7	8325064	Ames	GT	SETA	A	ALL	7	RPP	Revertant Numbers Per Plate	5.0	COLONIES	STANDARD DEVIATION	5.0	5.0	COLONIES				2015-08-03
8	8325064	Ames	GT	SETF	F	6_1	1	RPP	Revertant Numbers Per Plate	8	COLONIES		8	8	COLONIES			MANUALLY COUNTED	2015-08-03
9	8325064	Ames	GT	SETF	F	6_1	2	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
10	8325064	Ames	GT	SETF	F	6_2	3	RPP	Revertant Numbers Per Plate	10	COLONIES		10	10	COLONIES			MANUALLY COUNTED	2015-08-03
11	8325064	Ames	GT	SETF	F	6_2	2	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
12	8325064	Ames	GT	SETF	F	6_3	4	RPP	Revertant Numbers Per Plate	12	COLONIES		12	12	COLONIES			MANUALLY COUNTED	2015-08-03
13	8325064	Ames	GT	SETF	F	6_3	2	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
14	8325064	Ames	GT	SETF	ALL	ALL	5	RPPMEAN	Mean of Revertant Numbers Per Plate	10.0	COLONIES	MEAN	10.0	10.0	COLONIES				2015-08-03
15	8325064	Ames	GT	SETF	ALL	ALL	6	RPPSTDDV	Standard Deviation of Revertant Numbers Per Plate	2.0	COLONIES	STANDARD DEVIATION	2.0	2.0	COLONIES				2015-08-03
16	8325064	Ames	GT	SETF	ALL	ALL	7	RPPFDINC	Fold Increase of Revertant Numbers Per Plate	0.3	COLONIES	FOLD INCREASE	0.3	0.3	COLONIES				2015-08-03
17	8325064	Ames	GT	SETG	G	5_1	1	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
18	8325064	Ames	GT	SETG	G	5_2	2	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
19	8325064	Ames	GT	SETG	G	5_3	3	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
20	8325064	Ames	GT	SETR	R	18_1	1	RPP	Revertant Numbers Per Plate	812	COLONIES		812	812	COLONIES			INSTRUMENT COUNTED	2015-08-03
21	8325064	Ames	GT	SETR	R	18_2	2	RPP	Revertant Numbers Per Plate	912	COLONIES		912	912	COLONIES			INSTRUMENT COUNTED	2015-08-03
22	8325064	Ames	GT	SETR	R	18_3	3	RPP	Revertant Numbers Per Plate	839	COLONIES		839	839	COLONIES			INSTRUMENT COUNTED	2015-08-03
23	8325064	Ames	GT	SETR	R	ALL	4	RPPMEAN	Mean of Revertant Numbers Per Plate	854.3	COLONIES	MEAN	854.3	854.3	COLONIES				2015-08-03
24	8325064	Ames	GT	SETR	R	ALL	5	RPPSTDDV	Standard Deviation of Revertant Numbers Per Plate	51.7	COLONIES	STANDARD DEVIATION	51.7	51.7	COLONIES				2015-08-03
25	8325064	Ames	GT	SETR	R	ALL	6	RPPFLDINC	Fold Increase of Revertant Numbers Per Plate	6.4	COLONIES	FOLD INCREASE	6.4	6.4	COLONIES				2015-08-03

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