SEND Example.In vitro Bacterial Reverse Mutation Assay

This is an example showing the report table, trial design, and results from a study's in vitro bacterial reverse mutation test TOBA-774 - Getting issue details... STATUS TOBA-505 - Getting issue details... STATUS using 4 different amino acid-requiring strains of S. typhimurium and 1 strain of E. coli to detect point mutations. TOBA-129 - Getting issue details... STATUS

This table shows the assay results for study 8325064, test article TA1, and 3 strains of salmonella (TA98, TA100, and TA1535) at varying concentrations. For brevity, the remaining tables (e.g., additional strains, samples prepared without metabolic activation) are not included. TOBA-506 - Getting issue details... STATUS For ease of reference in the table below, each row has been labeled in the right-hand margin with the applicant-defined trial set label (e.g., SetA). For brevity, only the four bolded sets are represented in the following example datasets.

This example Trial Summary (TS) dataset TOBA-481 - Getting issue details... STATUS , TOBA-368 - Getting issue details... STATUS shows many informational fields TOBA-369 - Getting issue details... STATUS that provide context at the study level.

TOBA-663 - Getting issue details... STATUS TOBA-664 - Getting issue details... STATUS

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TOBA-367 - Getting issue details... STATUS

Rows 1-2:	Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, TOBA-366 - Getting issue details... STATUS since both GLP types apply for this study.
Row 8:	Shows that the applicant's study reference ID is not applicable.
Rows 9-12:	Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID=1). The study director is associated with the test facility.
Rows 14-16:	Show that TSGRPID (TSGRPID=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER). TOBA-56 - Getting issue details... STATUS
Row 18:	Shows that this study includes a Bacterial Reverse Mutation assessment.
Rows 19-23:	Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with 4 different strains and the cell line that are tested in this study.
Rows 25-27:	Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain and cell line that is tested in this study. TOBA-665 - Getting issue details... STATUS

ts.xpt

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Row	STUDYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	8325064	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	8325064	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	8325064	TS	1		STSTDTC	Study Start Date	2015-07-29
4	8325064	TS	1		STITLE	Study Title	The Bacterial Reverse Mutation Test, Study 8325064-1
5	8325064	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6	8325064	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
7	8325064	TS	1		APPLCNT	Applicant Organization	Example Applicant Inc.
8	8325064	TS	1		APREFID	Applicant's Study Reference ID		NOT APPLICABLE
9	8325064	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
10	8325064	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
11	8325064	TS	1	1	TFCNTRY	Test Facility Country	USA
12	8325064	TS	1	1	STDIR	Study Director	Dr. R. Smith
13	8325064	TS	1		GLPFL	GLP Flag	N
14	8325064	TS	1	4	TSTGDNAM	Testing Guideline Name	Test NO. 471
15	8325064	TS	1	4	TSTGDORG	Testing Guideline Organization	OECD
16	8325064	TS	1	4	TSTGDVER	Testing Guideline Version	2020-06-29
17	8325064	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
18	8325064	TS	1		GNTXAID	Genetic Toxicology Assay Identifier	AMES
19	8325064	TS	1	2	SPECIES TOBA-484 - Jira project doesn't exist or you don't have permission to view it.	Species	SALMONELLA TYPHIMURIUM TOBA-123 - Jira project doesn't exist or you don't have permission to view it.
20	8325064	TS	1	2	STRAIN	Strain/Substrain	TA98
21	8325064	TS	2	2	STRAIN	Strain/Substrain	TA100
22	8325064	TS	3	2	STRAIN	Strain/Substrain	TA1535
23	8325064	TS	4	2	STRAIN	Strain/Substrain	TA1537
24	8325064	TS	1	2	CELLLN	Cell Line
25	8325064	TS	1	3	SPECIES	Species	ESCHERICHIA COLI TOBA-482 - Jira project doesn't exist or you don't have permission to view it.
26	8325064	TS	5	3	STRAIN	Strain/Substrain	WP2 uvrA pKM101
27	8325064	TS	2	3	CELLLN	Cell Line

Dataset Debug Message

When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.

This example Trial Set (TX) dataset shows information about the test conditions for SetA and SetR in this study. For brevity, the dataset does not show information for SetF, SetG, or any other sets. TOBA-483 - Getting issue details... STATUS A fully formed TX dataset for this example study would include information about the test conditions for all sets.

Dataset Wrapper Debug Message

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Rows 1-14:	Show trial set SetSTM, with trial set parameters and trial set values that comprise the test conditions for all data for the species S. typhimurium.
Rows 15, 24, 33, 42:	Show that SetA, SetF, SetG, and SetR each have a parent set code of SetSTM. As a child set of SetSTM, each of these sets inherit the test conditions of SetSTM.
Rows 15-23:	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. TOBA-666 - Jira project doesn't exist or you don't have permission to view it.
Rows 24-32:	Show trial set parameters and trial set values that comprise the test conditions for the set SetF. SetF is the data for the strain of TA98 with a concentration value of 500 µg/plate. SetF is associated with the sixth row, labeled "SetF", in the report table for example study 8325064. TOBA-667 - Jira project doesn't exist or you don't have permission to view it.
Rows 33-41:	Show trial set parameters and trial set values that comprise the test conditions for the set SetG. SetG is the data for the strain of TA98 with a concentration value of 1600 µg/plate. SetG is associated with the seventh row, labeled "SetG", in the report table for example study 8325064.
Rows 42-50:	Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the strain of TA100, positive control with a concentration value of 2 µg/plate. SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
Row 10:	SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID, in this case CIG01a, matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2, Product Design Parameters and Conformance Testing, Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a. The TO domain is described in Section 2.8.8.1, Tobacco Product Identifiers and Descriptors (TO).
Row 13:	SPDEVID is the applicant-defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset (see also Section 2.8.9.7, SEND Device Identifiers (DI)). The value of SPDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1.
Row 14:	Shows a value for SMKRGM. SMKRGM serves as a link to the Device-In Use Properties (DU) domain (see also Section 2.8.9.8, SEND Device-In-Use (DU)), where a matching value of SMKRGM indicates parameters of the smoking regimen performed by the smoking machine, as in the DU dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 2.

Unable to render dataset table

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THIS (RED FONT) IS THE OLD DATASET PRIOR TO "flattening":

STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	1	SPECIES	Species	SALMONELLA TYPHIMURIUM
2	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	2	IVTDMIN	In vitro Treatment Duration Minimum	71.5
3	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	3	IVTDTRG	In vitro Treatment Duration Target	72
4	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	4	IVTDMAX	In vitro Treatment Duration Maximum	72.5
5	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	5	IVTDU	In vitro TreatmentRowDuration Unit	HOURS
6	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	6	INCBTMP	Incubation Temperature	37
7	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	7	INCBTMPU	Incubation Temperature Unit	C
8	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	8	ATMRHP	Atmospheric Relative Humidity Percent	50
9	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	9	ATMCO2P	Atmospheric CO2 Percent	5
10	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	10	SPTOBID	Applicant-defined tobacco identifier	CIG01a
11	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	11	EXPTYP	Exposure Type	Submerged
12	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	12	SAMTYP	Sample Type	Total Particulate Matter in PBS
13	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	13	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
14	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	14	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
15	8325064	TX	SetA	A-TA98-C0	15	PSETCD	Parent Set Code	SetSTM
16	8325064	TX	SetA	A-TA98-C0	15	STRAIN	Strain/Substrain	TA98
17	8325064	TX	SetA	A-TA98-C0	16	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
18	8325064	TX	SetA	A-TA98-C0	17	METACTFL	Presence of Metabolic Activation Flag	N
19	8325064	TX	SetA	A-TA98-C0	18	ITVNAM	Intervention Article Name	DMSO
20	8325064	TX	SetA	A-TA98-C0	19	ITVTYPE	Intervention Article Type	VEHICLE
21	8325064	TX	SetA	A-TA98-C0	20	ITVCONC	Intervention Article Concentration	100
22	8325064	TX	SetA	A-TA98-C0	21	ITVCONCU	Intervention Article Concentration Unit	%
23	8325064	TX	SetA	A-TA98-C0	22	TRTV	Treatment Vehicle	DMSO
24	8325064	TX	SetF	F-TA98-C500 TOBA-485 - Getting issue details... STATUS	23	PSETCD	Parent Set Code	SetSTM
25	8325064	TX	SetF	F-TA98-C500	24	STRAIN	Strain/Substrain	TA98
26	8325064	TX	SetF	F-TA98-C500	25	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
27	8325064	TX	SetF	F-TA98-C500	26	METACTFL	Presence of Metabolic Activation Flag	N
28	8325064	TX	SetF	F-TA98-C500	27	ITVNAM	Intervention Article Name	TA1
29	8325064	TX	SetF	F-TA98-C500	28	ITVTYPE	Intervention Article Type	PRODUCT
30	8325064	TX	SetF	F-TA98-C500	29	ITVCONC	Intervention Article Concentration	500
31	8325064	TX	SetF	F-TA98-C500	30	ITVCONCU	Intervention Article Concentration Unit	ug/plate
32	8325064	TX	SetF	F-TA98-C500	31	TRTV	Treatment Vehicle	DMSO
33	8325064	TX	SetG	G-TA98-C1600	31	PSETCD	Parent Set Code	SetSTM
34	8325064	TX	SetG	G-TA98-C1600	32	STRAIN	Strain/Substrain	TA98
35	8325064	TX	SetG	G-TA98-C1600	33	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
36	8325064	TX	SetG	G-TA98-C1600	34	METACTFL	Presence of Metabolic Activation Flag	N
37	8325064	TX	SetG	G-TA98-C1600	35	ITVNAM	Intervention Article Name	TA1
38	8325064	TX	SetG	G-TA98-C1600	36	ITVTYPE	Intervention Article Type	Product
39	8325064	TX	SetG	G-TA98-C1600	37	ITVCONC	Intervention Article Concentration	1600
40	8325064	TX	SetG	G-TA98-C1600	38	ITVCONCU	Intervention Article Concentration Unit	ug/plate
41	8325064	TX	SetG	G-TA98-C1600	39	TRTV	Treatment Vehicle	DMSO
42	8325064	TX	SetR	R-TA100-C2	39	PSETCD	Parent Set Code	SetSTM
43	8325064	TX	SetR	R-TA100-C2	40	STRAIN	Strain/Substrain	TA100
44	8325064	TX	SetR	R-TA100-C2	41	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
45	8325064	TX	SetR	R-TA100-C2	42	METACTFL	Presence of Metabolic Activation Flag	N
46	8325064	TX	SetR	R-TA100-C2	43	ITVNAM	Intervention Article Name	NaN3
47	8325064	TX	SetR	R-TA100-C2	44	ITVTYPE	Intervention Article Type	Positive Control
48	8325064	TX	SetR	R-TA100-C2	45	ITVCONC	Intervention Article Concentration	2
49	8325064	TX	SetR	R-TA100-C2	46	ITVCONCU	Intervention Article Concentration Unit	ug/plate
50	8325064	TX	SetR	R-TA100-C2	47	TRTV	Treatment Vehicle	DMSO

THIS IS A DRAFTED MOCK-UP OF THE "flattened" version of TX dataset:

STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	1	SPECIES	Species	SALMONELLA TYPHIMURIUM
2	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	2	IVTDMIN	In vitro Treatment Duration Minimum	71.5
3	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	3	IVTDTRG	In vitro Treatment Duration Target	72
4	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	4	IVTDMAX	In vitro Treatment Duration Maximum	72.5
5	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	5	IVTDU	In vitro TreatmentRowDuration Unit	HOURS
6	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	6	INCBTMP	Incubation Temperature	37
7	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	7	INCBTMPU	Incubation Temperature Unit	C
8	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	8	ATMRHP	Atmospheric Relative Humidity Percent	50
9	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	9	ATMCO2P	Atmospheric CO2 Percent	5
10	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	10	SPTOBID	Applicant-defined tobacco identifier	CIG01a
11	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	11	EXPTYP	Exposure Type	Submerged
12	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	12	SAMTYP	Sample Type	Total Particulate Matter in PBS
13	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	13	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
14	8325064	TX	SetSTM	SALMONELLA TYPHIMURIUM	14	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
15	8325064	TX	SetA	A-TA98-C0	1	SPECIES	Species	SALMONELLA TYPHIMURIUM
16	8325064	TX	SetA	A-TA98-C0	2	IVTDMIN	In vitro Treatment Duration Minimum	71.5
17	8325064	TX	SetA	A-TA98-C0	3	IVTDTRG	In vitro Treatment Duration Target	72
18	8325064	TX	SetA	A-TA98-C0	4	IVTDMAX	In vitro Treatment Duration Maximum	72.5
19	8325064	TX	SetA	A-TA98-C0	5	IVTDU	In vitro TreatmentRowDuration Unit	HOURS
20	8325064	TX	SetA	A-TA98-C0	6	INCBTMP	Incubation Temperature	37
21	8325064	TX	SetA	A-TA98-C0	7	INCBTMPU	Incubation Temperature Unit	C
22	8325064	TX	SetA	A-TA98-C0	8	ATMRHP	Atmospheric Relative Humidity Percent	50
23	8325064	TX	SetA	A-TA98-C0	9	ATMCO2P	Atmospheric CO2 Percent	5
24	8325064	TX	SetA	A-TA98-C0	10	SPTOBID	Applicant-defined tobacco identifier	CIG01a
25	8325064	TX	SetA	A-TA98-C0	11	EXPTYP	Exposure Type	Submerged
26	8325064	TX	SetA	A-TA98-C0	12	SAMTYP	Sample Type	Total Particulate Matter in PBS
27	8325064	TX	SetA	A-TA98-C0	13	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
28	8325064	TX	SetA	A-TA98-C0	14	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
29	8325064	TX	SetA	A-TA98-C0	15	PSETCD	Parent Set Code	SetSTM
30	8325064	TX	SetA	A-TA98-C0	15	STRAIN	Strain/Substrain	TA98
31	8325064	TX	SetA	A-TA98-C0	16	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
32	8325064	TX	SetA	A-TA98-C0	17	METACTFL	Presence of Metabolic Activation Flag	N
33	8325064	TX	SetA	A-TA98-C0	18	ITVNAM	Intervention Article Name	DMSO
34	8325064	TX	SetA	A-TA98-C0	19	ITVTYPE	Intervention Article Type	VEHICLE
35	8325064	TX	SetA	A-TA98-C0	20	ITVCONC	Intervention Article Concentration	100
36	8325064	TX	SetA	A-TA98-C0	21	ITVCONCU	Intervention Article Concentration Unit	%
37	8325064	TX	SetA	A-TA98-C0	22	TRTV	Treatment Vehicle	DMSO
38	8325064	TX	SetF	F-TA98-C500 TOBA-485 - Getting issue details... STATUS	23	PSETCD	Parent Set Code	SetSTM
39	8325064	TX	SetF	F-TA98-C500	24	STRAIN	Strain/Substrain	TA98
40	8325064	TX	SetF	F-TA98-C500	25	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
41	8325064	TX	SetF	F-TA98-C500	26	METACTFL	Presence of Metabolic Activation Flag	N
42	8325064	TX	SetF	F-TA98-C500	27	ITVNAM	Intervention Article Name	TA1
43	8325064	TX	SetF	F-TA98-C500	28	ITVTYPE	Intervention Article Type	PRODUCT
44	8325064	TX	SetF	F-TA98-C500	29	ITVCONC	Intervention Article Concentration	500
45	8325064	TX	SetF	F-TA98-C500	30	ITVCONCU	Intervention Article Concentration Unit	ug/plate
46	8325064	TX	SetF	F-TA98-C500	31	TRTV	Treatment Vehicle	DMSO
47	8325064	TX	SetG	G-TA98-C1600	31	PSETCD	Parent Set Code	SetSTM
48	8325064	TX	SetG	G-TA98-C1600	32	STRAIN	Strain/Substrain	TA98
49	8325064	TX	SetG	G-TA98-C1600	33	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
50	8325064	TX	SetG	G-TA98-C1600	34	METACTFL	Presence of Metabolic Activation Flag	N
51	8325064	TX	SetG	G-TA98-C1600	35	ITVNAM	Intervention Article Name	TA1
52	8325064	TX	SetG	G-TA98-C1600	36	ITVTYPE	Intervention Article Type	Product
53	8325064	TX	SetG	G-TA98-C1600	37	ITVCONC	Intervention Article Concentration	1600
54	8325064	TX	SetG	G-TA98-C1600	38	ITVCONCU	Intervention Article Concentration Unit	ug/plate
55	8325064	TX	SetG	G-TA98-C1600	39	TRTV	Treatment Vehicle	DMSO
56	8325064	TX	SetR	R-TA100-C2	39	PSETCD	Parent Set Code	SetSTM
57	8325064	TX	SetR	R-TA100-C2	40	STRAIN	Strain/Substrain	TA100
58	8325064	TX	SetR	R-TA100-C2	41	METACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
59	8325064	TX	SetR	R-TA100-C2	42	METACTFL	Presence of Metabolic Activation Flag	N
60	8325064	TX	SetR	R-TA100-C2	43	ITVNAM	Intervention Article Name	NaN3
61	8325064	TX	SetR	R-TA100-C2	44	ITVTYPE	Intervention Article Type	Positive Control
62	8325064	TX	SetR	R-TA100-C2	45	ITVCONC	Intervention Article Concentration	2
63	8325064	TX	SetR	R-TA100-C2	46	ITVCONCU	Intervention Article Concentration Unit	ug/plate
64	8325064	TX	SetR	R-TA100-C2	47	TRTV	Treatment Vehicle	DMSO

REFID values are defined by the applicant to uniquely identify the observational unit within an experimental unit. In the simplified diagram of an assay procedure (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, TOBA-370 - Getting issue details... STATUS trial sets, or observational units for the example study. For study 8325064, the applicant chose to define the REFIDs at the trial set level with a single character (e.g., A, F, G, R) and chose to define REFIDs at the observational level based on the location of each tube in 1 of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).

Dataset Wrapper Debug Message

Row captions have been provided, but there doesn't seem to be a dataset to which the row captions would apply.

Row 1:	Shows the value of REFID=STM. This REFID refers to the trial set with a SETCD of "SetSTM" TOBA-489 - Jira project doesn't exist or you don't have permission to view it. , as defined in the TX dataset. LEVEL=1 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 1, 2, 8, 12, 16:	Show that the trial set SetSTM is the parent of set codes SetA, SetF, SetG, and SetR.
Row 2:	Shows the value of REFID=A. This REFID refers to the trial set with a SETCD of "SetA", as defined in the TX dataset. LEVEL=2 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, DMSO.
Rows 3-7:	Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A.
Row 8:	Shows the value of REFID=F. This REFID refers to the trial set with a SETCD of "SetF", as defined in the TX dataset. LEVEL=2 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1.
Rows 9-11:	Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F.
Row 12:	Shows the value of REFID=G. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=2 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, TA1.
Rows 13-15:	Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G.
Row 16:	Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=2 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET". TRIAL SET indicates this identifier relates to the entire trial set. EXPERIMENTAL UNIT indicates this identifier received the intervention article, NaN3.
Rows 17-19:	Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R. TOBA-668 - Jira project doesn't exist or you don't have permission to view it.

Unable to render dataset table

Please place only one table inside the macro.

OLD TABLE (prior to flattening Parent/Child in TX dataset)

When this table is removed, remove SetSTM from TX.

Row	STUDYID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	8325064	SetSTM	STM		1	TRIAL SET
2	8325064	SetA	A	STM	2	EXPERIMENTAL UNIT/TRIAL SET
3	8325064	SetA	1_1	A	3	OBSERVATIONAL UNIT
4	8325064	SetA	1_2	A	3	OBSERVATIONAL UNIT
5	8325064	SetA	1_3	A	3	OBSERVATIONAL UNIT
6	8325064	SetA	1_4	A	3	OBSERVATIONAL UNIT
7	8325064	SetA	1_5	A	3	OBSERVATIONAL UNIT
8	8325064	SetF	F	STM	2	EXPERIMENTAL UNIT/TRIAL SET
9	8325064	SetF	6_1	F	3	OBSERVATIONAL UNIT
10	8325064	SetF	6_2	F	3	OBSERVATIONAL UNIT
11	8325064	SetF	6_3	F	3	OBSERVATIONAL UNIT
12	8325064	SetG	G	STM	2	EXPERIMENTAL UNIT/TRIAL SET
13	8325064	SetG	7_1	G	3	OBSERVATIONAL UNIT
14	8325064	SetG	7_2	G	3	OBSERVATIONAL UNIT
15	8325064	SetG	7_3	G	3	OBSERVATIONAL UNIT
16	8325064	SetG	R	STM	2	EXPERIMENTAL UNIT/TRIAL SET
17	8325064	SetR	18_1	R	3	OBSERVATIONAL UNIT
18	8325064	SetR	18_2	R	3	OBSERVATIONAL UNIT
19	8325064	SetR	18_3	R	3	OBSERVATIONAL UNIT

NEW (remain AFTER we flatten TX dataset)

Row	STUDYID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	8325064	SetA	A		1	EXPERIMENTAL UNIT/TRIAL SET
2	8325064	SetA	1_1	A	2	OBSERVATIONAL UNIT
3	8325064	SetA	1_2	A	2	OBSERVATIONAL UNIT
4	8325064	SetA	1_3	A	2	OBSERVATIONAL UNIT
5	8325064	SetA	1_4	A	2	OBSERVATIONAL UNIT
6	8325064	SetA	1_5	A	2	OBSERVATIONAL UNIT
7	8325064	SetF	F		1	EXPERIMENTAL UNIT/TRIAL SET
8	8325064	SetF	6_1	F	2	OBSERVATIONAL UNIT
9	8325064	SetF	6_2	F	2	OBSERVATIONAL UNIT
10	8325064	SetF	6_3	F	2	OBSERVATIONAL UNIT
11	8325064	SetG	G		1	EXPERIMENTAL UNIT/TRIAL SET
12	8325064	SetG	7_1	G	2	OBSERVATIONAL UNIT
13	8325064	SetG	7_2	G	2	OBSERVATIONAL UNIT
14	8325064	SetG	7_3	G	2	OBSERVATIONAL UNIT
15	8325064	SetG	R		1	EXPERIMENTAL UNIT/TRIAL SET
16	8325064	SetR	18_1	R	2	OBSERVATIONAL UNIT
17	8325064	SetR	18_2	R	2	OBSERVATIONAL UNIT
18	8325064	SetR	18_3	R	2	OBSERVATIONAL UNIT

TOBA-454 - Getting issue details... STATUS

Rows 1-5:	Show the number of revertant colonies per plate collected for each of 5 observational units, GTREFID=1_1 through 1_5 (see description in the RELREF dataset).
Rows 6, 7:	Show summary values collected (mean, standard deviation) for GTREFID=A that apply to the entire trial set, SetA, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID as shown in the RELREF dataset.
Rows 8-13:	Revertent colonies were counted for each of 3 plates/observational units (GTREFID=6_1 through 6_3) and each value is associated with a record to show a postfix code of "V" (Very thin background bacterial lawn).
Rows 14-16:	Show summary values collected (mean, standard deviation, fold increase) for GTREFID=F that apply to the entire trial set, SetF, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset.
Rows 17-19:	Show 3 plates/observational units (GTREFID=7_1 through 7_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T". TOBA-668 - Jira project doesn't exist or you don't have permission to view it.
Rows 20-22:	Show the number of revertant colonies per plate collected for each of 3 observational units (GTREFID=18_1 through 18_3).
Rows 23-25:	Show summary values collected (mean, standard deviation, fold increase) for GTREFID=R that apply to the entire trial set, SetR, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset.

gt.xpt

Row	STUDYID	DOMAIN	GTSEQ	GTREFID	GTTESTCD	GTTEST	GTORRES	GTORRESU	GTCOLSRT	GTSTRESC	GTSTRESN	GTSTRESU	GTSTAT	GTREASND	GTMETHOD	GTDTC
1	8325064	GT	1	1_1	RPP	Revertant Colony Numbers Per Plate	26	NOT APPLICABLE		26	26	NOT APPLICABLE TOBA-487 - Jira project doesn't exist or you don't have permission to view it.			INSTRUMENT COUNTED	2015-08-03
2	8325064	GT	2	1_2	RPP	Revertant Colony Numbers Per Plate	35	NOT APPLICABLE		35	35	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
3	8325064	GT	3	1_3	RPP	Revertant Colony Numbers Per Plate	39	NOT APPLICABLE		39	39	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
4	8325064	GT	4	1_4	RPP	Revertant Colony Numbers Per Plate	35	NOT APPLICABLE		35	35	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
5	8325064	GT	5	1_5	RPP	Revertant Colony Numbers Per Plate	30	NOT APPLICABLE		30	30	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
6	8325064	GT	6	A	RPP	Revertant Colony Numbers Per Plate	33.0	NOT APPLICABLE	MEAN	33.0	33.0	NOT APPLICABLE				2015-08-03
7	8325064	GT	7	A	RPP	Revertant Colony Numbers Per Plate	5.0	NOT APPLICABLE	STANDARD DEVIATION	5.0	5.0	NOT APPLICABLE				2015-08-03
8	8325064	GT	1	6_1	RPP	Revertant Colony Numbers Per Plate	8	NOT APPLICABLE		8	8	NOT APPLICABLE			MANUALLY COUNTED	2015-08-03
9	8325064	GT	2	6_1	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
10	8325064	GT	3	6_2	RPP	Revertant Colony Numbers Per Plate	10	NOT APPLICABLE		10	10	NOT APPLICABLE			MANUALLY COUNTED	2015-08-03
11	8325064	GT	4	6_2	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
12	8325064	GT	5	6_3	RPP	Revertant Colony Numbers Per Plate	12	NOT APPLICABLE		12	12	NOT APPLICABLE			MANUALLY COUNTED	2015-08-03
13	8325064	GT	6	6_3	CYTOTOX	Cytotoxicity	Very thin background bacterial lawn			V						2015-08-03
14	8325064	GT	7	F	RPPMEAN	Mean Rev Colony Num Per Plate	10.0	NOT APPLICABLE	MEAN	10.0	10.0	NOT APPLICABLE				2015-08-03
15	8325064	GT	8	F	RPPSTDDV	Std Dev Rev Colony Num Per Plate	2.0	NOT APPLICABLE	STANDARD DEVIATION	2.0	2.0	NOT APPLICABLE				2015-08-03
16	8325064	GT	9	F	RPPFLDIC	Fold Increase Rev Colony Num Per Plate	0.3	NOT APPLICABLE	FOLD INCREASE	0.3	0.3	NOT APPLICABLE				2015-08-03
17	8325064	GT	1	7_1	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
18	8325064	GT	2	7_2	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
19	8325064	GT	3	7_3	CYTOTOX	Cytotoxicity	Toxic No Revertant Colonies			T			NOT DONE	TOO MUCH CYTOTOXICITY		2015-08-03
20	8325064	GT	1	18_1	RPP	Revertant Colony Numbers Per Plate	812	NOT APPLICABLE		812	812	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
21	8325064	GT	2	18_2	RPP	Revertant Colony Numbers Per Plate	912	NOT APPLICABLE		912	912	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
22	8325064	GT	3	18_3	RPP	Revertant Colony Numbers Per Plate	839	NOT APPLICABLE		839	839	NOT APPLICABLE			INSTRUMENT COUNTED	2015-08-03
23	8325064	GT	4	R	RPPMEAN	Mean Rev Colony Num Per Plate	854.3	NOT APPLICABLE	MEAN	854.3	854.3	NOT APPLICABLE				2015-08-03
24	8325064	GT	5	R	RPPSTDDV	Std Dev Rev Colony Num Per Plate	51.7	NOT APPLICABLE	STANDARD DEVIATION	51.7	51.7	NOT APPLICABLE				2015-08-03
25	8325064	GT	6	R	RPPFLDIC	Fold Increase Rev Colony Num Per Plate	6.4	NOT APPLICABLE	FOLD INCREASE	6.4	6.4	NOT APPLICABLE				2015-08-03

Dataset Debug Message

When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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