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This is an example showing the report table, trial design and results data of Study #8325064 for the determination of the in vitro bacterial reverse mutation test ~~potential of 10 tobacco products in the in vitro Micronucleus Assay~~

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, and results from a study's in vitro bacterial reverse mutation test

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using 4 different amino acid-requiring strains of

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S. typhimurium

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and 1 strain of E. coli

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to detect point mutations

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.

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title	Report Table for Example Study 8325064

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. 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.

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This example Trial Summary (TS) dataset, shows many informational fields that provide context at the study level.

Dataset wrap

Rowcaps

Rows 1-2:	Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this study.
Row 3:	Shows that this study was conducted as a GLP study.
Rows 4-5:	Show the study start date and study title.
Rows 6-7:	Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study.
Row 8:	Shows the applicant's organization.
Row 9:	Shows that the applicant's study reference ID is not applicable.
Rows 10-13:	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).
Row 17:	Shows the study type for this study.
Row 18:	Shows that this study includes a Bacterial Reverse Mutation Assay.
Rows 19-27:	Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with the 4 different strains and cell lines that are tested in this study.
Rows 28-30:	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.

Dataset2

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		GLPFL	GLP Flag	N
4	8325064	TS	1		STSTDTC	Study Start Date	2015-07-29
5	8325064	TS	1		STITLE	Study Title	The Bacterial Reverse Mutation Test, Study 8325064-1
6	8325064	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7	8325064	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
8	8325064	TS	1		APPLCNT	Applicant	Example Applicant Inc.
9	8325064	TS	1		APREFID	Applicant's Study Reference ID		NOT APPLICABLE
10	8325064	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
11	8325064	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
12	8325064	TS	1	1	TFCNTRY	Test Facility Country	USA
13	8325064	TS	1	1	STDIR	Study Director	Dr. R. Smith
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	Species	SALMONELLA TYPHIMURIUM
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	TA 98 hisD3052; rfa-; uvrB-
25	8325064	TS	2	2	CELLLN	Cell Line	TA 100 hisG46; rfa-; uvrB-
26	8325064	TS	3	2	CELLLN	Cell Line	TA 1535 hisG46; rfa-; uvrB-
27	8325064	TS	4	2	CELLLN	Cell Line	TA 1537 hisC3076; rfa-; uvrB-
28	8325064	TS	2	3	SPECIES	Species	ESCHERICHIA COLI
29	8325064	TS	5	3	STRAIN	Strain/Substrain	WP2 uvrA pKM101
30	8325064	TS	5	3	CELLLN	Cell Line	trpE uvrA

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. A fully formed TX dataset for this example study would include information about the test conditions for all sets.

Note that there are three trial set parameters that link to other important datasets: SPTOBID, APDEVID, and SMKRGM.

SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID (e.g., 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).
The value of APDEVID (e.g., PUFFMASTER3K) matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. 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)). This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1.
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.

Dataset wrap

Name	tx

Rowcaps

Rows 1-22:	Show trial set parameters and trial set values that are the test conditions specific to set SetA which is 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 SetF which is 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.
Rows 45-66:	Show trial set parameters and trial set values that comprise the test conditions for the set SetG which is 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 67-88:	Show trial set parameters and trial set values that comprise the test conditions for the set SetR which is 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.

Dataset2

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	8325064	TX	SetA	A-TA98-C0	1	SPECIES	Species	SALMONELLA TYPHIMURIUM
2	8325064	TX	SetA	A-TA98-C0	2	IVTDMIN	In vitro Treatment Duration Minimum	71.5
3	8325064	TX	SetA	A-TA98-C0	3	IVTDTRG	In vitro Treatment Duration Target	72
4	8325064	TX	SetA	A-TA98-C0	4	IVTDMAX	In vitro Treatment Duration Maximum	72.5
5	8325064	TX	SetA	A-TA98-C0	5	IVTDU	In vitro Treatment Duration Unit	HOURS
6	8325064	TX	SetA	A-TA98-C0	6	INCBTMP	Incubation Temperature	37
7	8325064	TX	SetA	A-TA98-C0	7	INCBTMPU	Incubation Temperature Unit	C
8	8325064	TX	SetA	A-TA98-C0	8	ATMRHP	Atmospheric Relative Humidity Percent	50
9	8325064	TX	SetA	A-TA98-C0	9	ATMCO2P	Atmospheric CO2 Percent	5
10	8325064	TX	SetA	A-TA98-C0	10	SPTOBID	Applicant-defined tobacco identifier	CIG01a
11	8325064	TX	SetA	A-TA98-C0	11	EXPTYP	Exposure Type	Submerged
12	8325064	TX	SetA	A-TA98-C0	12	SAMTYP	Sample Type	Total Particulate Matter in PBS
13	8325064	TX	SetA	A-TA98-C0	13	APDEVID	Applicant-defined device identifier	PUFFMASTER3K
14	8325064	TX	SetA	A-TA98-C0	14	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
15	8325064	TX	SetA	A-TA98-C0	15	STRAIN	Strain/Substrain	TA98
16	8325064	TX	SetA	A-TA98-C0	16	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
17	8325064	TX	SetA	A-TA98-C0	17	METACTFL	Presence of Metabolic Activation Flag	N
18	8325064	TX	SetA	A-TA98-C0	18	ITVNAM	Intervention Article Name	DMSO
19	8325064	TX	SetA	A-TA98-C0	19	ITVTYPE	Intervention Article Type	VEHICLE
20	8325064	TX	SetA	A-TA98-C0	20	ITVCONC	Intervention Article Concentration	100
21	8325064	TX	SetA	A-TA98-C0	21	ITVCONCU	Intervention Article Concentration Unit	%
22	8325064	TX	SetA	A-TA98-C0	22	TRTV	Treatment Vehicle	DMSO
23	8325064	TX	SetF	F-TA98-C500	23	SPECIES	Species	SALMONELLA TYPHIMURIUM
24	8325064	TX	SetF	F-TA98-C500	24	IVTDMIN	In vitro Treatment Duration Minimum	71.5
25	8325064	TX	SetF	F-TA98-C500	25	IVTDTRG	In vitro Treatment Duration Target	72
26	8325064	TX	SetF	F-TA98-C500	26	IVTDMAX	In vitro Treatment Duration Maximum	72.5
27	8325064	TX	SetF	F-TA98-C500	27	IVTDU	In vitro Treatment Duration Unit	HOURS
28	8325064	TX	SetF	F-TA98-C500	28	INCBTMP	Incubation Temperature	37
29	8325064	TX	SetF	F-TA98-C500	29	INCBTMPU	Incubation Temperature Unit	C
30	8325064	TX	SetF	F-TA98-C500	30	ATMRHP	Atmospheric Relative Humidity Percent	50
31	8325064	TX	SetF	F-TA98-C500	31	ATMCO2P	Atmospheric CO2 Percent	5
32	8325064	TX	SetF	F-TA98-C500	32	SPTOBID	Applicant-defined tobacco identifier	CIG01a
33	8325064	TX	SetF	F-TA98-C500	33	EXPTYP	Exposure Type	Submerged
34	8325064	TX	SetF	F-TA98-C500	34	SAMTYP	Sample Type	Total Particulate Matter in PBS
35	8325064	TX	SetF	F-TA98-C500	35	APDEVID	Applicant-defined device identifier	PUFFMASTER3K
36	8325064	TX	SetF	F-TA98-C500	36	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
37	8325064	TX	SetF	F-TA98-C500	37	STRAIN	Strain/Substrain	TA98
38	8325064	TX	SetF	F-TA98-C500	38	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
39	8325064	TX	SetF	F-TA98-C500	39	METACTFL	Presence of Metabolic Activation Flag	N
40	8325064	TX	SetF	F-TA98-C500	40	ITVNAM	Intervention Article Name	TA1
41	8325064	TX	SetF	F-TA98-C500	41	ITVTYPE	Intervention Article Type	PRODUCT
42	8325064	TX	SetF	F-TA98-C500	42	ITVCONC	Intervention Article Concentration	500
43	8325064	TX	SetF	F-TA98-C500	43	ITVCONCU	Intervention Article Concentration Unit	ug/plate
44	8325064	TX	SetF	F-TA98-C500	44	TRTV	Treatment Vehicle	DMSO
45	8325064	TX	SetG	G-TA98-C1600	45	SPECIES	Species	SALMONELLA TYPHIMURIUM
46	8325064	TX	SetG	G-TA98-C1600	46	IVTDMIN	In vitro Treatment Duration Minimum	71.5
47	8325064	TX	SetG	G-TA98-C1600	47	IVTDTRG	In vitro Treatment Duration Target	72
48	8325064	TX	SetG	G-TA98-C1600	48	IVTDMAX	In vitro Treatment Duration Maximum	72.5
49	8325064	TX	SetG	G-TA98-C1600	49	IVTDU	In vitro Treatment Duration Unit	HOURS
50	8325064	TX	SetG	G-TA98-C1600	50	INCBTMP	Incubation Temperature	37
51	8325064	TX	SetG	G-TA98-C1600	51	INCBTMPU	Incubation Temperature Unit	C
52	8325064	TX	SetG	G-TA98-C1600	52	ATMRHP	Atmospheric Relative Humidity Percent	50
53	8325064	TX	SetG	G-TA98-C1600	53	ATMCO2P	Atmospheric CO2 Percent	5
54	8325064	TX	SetG	G-TA98-C1600	54	SPTOBID	Applicant-defined tobacco identifier	CIG01a
55	8325064	TX	SetG	G-TA98-C1600	55	EXPTYP	Exposure Type	Submerged
56	8325064	TX	SetG	G-TA98-C1600	56	SAMTYP	Sample Type	Total Particulate Matter in PBS
57	8325064	TX	SetG	G-TA98-C1600	57	APDEVID	Applicant-defined device identifier	PUFFMASTER3K
58	8325064	TX	SetG	G-TA98-C1600	58	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
59	8325064	TX	SetG	G-TA98-C1600	59	STRAIN	Strain/Substrain	TA98
60	8325064	TX	SetG	G-TA98-C1600	60	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
61	8325064	TX	SetG	G-TA98-C1600	61	METACTFL	Presence of Metabolic Activation Flag	N
62	8325064	TX	SetG	G-TA98-C1600	62	ITVNAM	Intervention Article Name	TA1
63	8325064	TX	SetG	G-TA98-C1600	63	ITVTYPE	Intervention Article Type	Product
64	8325064	TX	SetG	G-TA98-C1600	64	ITVCONC	Intervention Article Concentration	1600
65	8325064	TX	SetG	G-TA98-C1600	65	ITVCONCU	Intervention Article Concentration Unit	ug/plate
66	8325064	TX	SetG	G-TA98-C1600	66	TRTV	Treatment Vehicle	DMSO
67	8325064	TX	SetR	R-TA100-C2	67	SPECIES	Species	SALMONELLA TYPHIMURIUM
68	8325064	TX	SetR	R-TA100-C2	68	IVTDMIN	In vitro Treatment Duration Minimum	71.5
69	8325064	TX	SetR	R-TA100-C2	69	IVTDTRG	In vitro Treatment Duration Target	72
70	8325064	TX	SetR	R-TA100-C2	70	IVTDMAX	In vitro Treatment Duration Maximum	72.5
71	8325064	TX	SetR	R-TA100-C2	71	IVTDU	In vitro Treatment Duration Unit	HOURS
72	8325064	TX	SetR	R-TA100-C2	72	INCBTMP	Incubation Temperature	37
73	8325064	TX	SetR	R-TA100-C2	73	INCBTMPU	Incubation Temperature Unit	C
74	8325064	TX	SetR	R-TA100-C2	74	ATMRHP	Atmospheric Relative Humidity Percent	50
75	8325064	TX	SetR	R-TA100-C2	75	ATMCO2P	Atmospheric CO2 Percent	5
76	8325064	TX	SetR	R-TA100-C2	76	SPTOBID	Applicant-defined tobacco identifier	CIG01a
77	8325064	TX	SetR	R-TA100-C2	77	EXPTYP	Exposure Type	Submerged
78	8325064	TX	SetR	R-TA100-C2	78	SAMTYP	Sample Type	Total Particulate Matter in PBS
79	8325064	TX	SetR	R-TA100-C2	79	APDEVID	Applicant-defined device identifier	PUFFMASTER3K
80	8325064	TX	SetR	R-TA100-C2	80	SMKRGM	Smoking Regimen	NON-INTENSE REGIMEN
81	8325064	TX	SetR	R-TA100-C2	81	STRAIN	Strain/Substrain	TA100
82	8325064	TX	SetR	R-TA100-C2	82	MTACTIND	Metabolic Activating Agent Name	NOT APPLICABLE
83	8325064	TX	SetR	R-TA100-C2	83	METACTFL	Presence of Metabolic Activation Flag	N
84	8325064	TX	SetR	R-TA100-C2	84	ITVNAM	Intervention Article Name	NaN3
85	8325064	TX	SetR	R-TA100-C2	85	ITVTYPE	Intervention Article Type	Positive Control
86	8325064	TX	SetR	R-TA100-C2	86	ITVCONC	Intervention Article Concentration	2
87	8325064	TX	SetR	R-TA100-C2	87	ITVCONCU	Intervention Article Concentration Unit	ug/plate
88	8325064	TX	SetR	R-TA100-C2	88	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, 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).

Image Added

Dataset wrap

Name	relref

Rowcaps

Row 1:	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=1 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 2-6:	Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A.
Row 7:	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=1 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 8-10:	Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F.
Row 11:	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=1 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 12-14:	Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G.
Row 15:	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=1 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 16-18:	Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R.

Dataset2

tableid	relref.xpt

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	SetR	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

Dataset wrap

Name	gt

Rowcaps

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".

Jira

showSummary	false
server	Issue Tracker (JIRA)
columnIds	issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution
columns	key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-668

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.

Dataset2

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

Image Removed

Info
red font - indicates potential for CT code lists green font - links to other domains purple font - to be discussed

Expand

title	Study 123, Report Table

Image Removed

Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data.
What is the best ASSAYID, Species, Test System, GLP?

During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level

A1: Image Removed

A2: Image Removed

...

Expand

title	ts.xpt (trial summary, study level parameters)

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1

123

Ames

TS

1

GLPTYP

Good Laboratory Practice Type

FDA

2

123

Ames

TS

2

GLPTYP

Good Laboratory Practice Type

OECD

3

123

Ames

TS

1

STSTDTC

Study Start Date

2015-07-29

4

123

TS

1

STITLE

Study Title

~~Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay~~

5

123

TS

1

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0

6

123

TS

1

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30

7

123

TS

1

SSPONSOR

Sponsor Organization

Example Sponsor Inc.

8

123

TS

1

SPREFID

Sponsor's Study Reference ID

NOT APPLICABLE

9

123

TS

1

TSTFNAM

Test Facility Name

Example Tox Lab Name

10

123

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

11

123

TS

1

TFCNTRY

Test Facility Country

USA

12

123

TS

1

STDIR

Study Director

Dr. R. Smith

13

123

TS

1

GLPFL

GLP Flag

N

14

123

TS

1

ASTD

Assay Standard

OECD Test No. 471

15

123

TS

1

ASTDV

Assay Standard Version

2020-06-29

16

123

TS

1

SSTYP

Study Type

GENOTOXICITY IN VITRO

17

123

TS

1

SSSTYP

Study Sub Type

Bacterial Reverse Mutation Test

18

123

TS

1

SPECIES

Species

Homo Sapiens

19

123

TS

1

??

Test System?

TK6 Lymphoblastoid Suspension Cells

Expand

title	tx.xpt (trial sets)

Row

STUDYID

ASSAYID

DOMAIN

SETCD

SET (what sponsor calls it)

TXSEQ

TXPARMCD

TXPARM

TXVAL

123

MNvit

TX

A1

(table 1, row 1, ST exposure with S9)

METACT

Metabolic Activation (should there be two parms? Presence, type)?

+S9

123

MNvit

TX

A1

TRTDRTRG

Treatment Duration target. (how do we show 3-6 hour range? start/end, target and tolerance?, one text field not-analyzable)

3

123

MNvit

TX

A1

TRTDRTOL

Treatment Duration Tolerance

123

MNvit

TX

A1

TRTDURU

Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)

H

123

MNvit

TX

A1

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

Tobacco ProdA

123

MNvit

TX

A1

ITVTYPE

type of intervention article

choices of values: product; negative control; positive control

Product

123

MNvit

TX

A1

ITVCONC

Concentration of intervention article

0

123

MNvit

TX

A1

ITVCONCU

Concentration Unit

ug/ml

123

MNvit

TX

A2

(table 1, row 2)

METACT

Metabolic Activation (should there be two parms? Presence, type)?

+S9

123

MNvit

TX

A2

TRTDRTRG

Treatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)

3

123

MNvit

TX

A2

TRTDRTOL

Treatment Duration Tolerance

123

MNvit

TX

A2

TRTDURU

Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)

H

123

MNvit

TX

A2

INTRVN

name of the intervention article

Tobacco ProdA

123

MNvit

TX

A2

ITVTYPE

type of intervention article

Product

123

MNvit

TX

A2

ITVCONC

Concentration of i a

1250

123

MNvit

TX

A2

ITVCONCU

Concentration Unit

ug/ml

...

Expand

title	gt.xpt (similar to LB)

A1: Image Removed

A2: Image Removed

Row

STUDYID

ASSAYID

DOMAIN

TXSETCD

GTSEQ

GTTESTCD

GTTEST

GTCELLEV
(cells evaluated)

GTORRES

GTORRESU

GTSTRESC

GTSTRESN

GTSTRESU

GTDTC

1

123

MNvit

GT

A1

1

RICC

Relative Increase in Cell Count

1540000

0

%

0

%

2022-05-25

2

123

MNvit

GT

A1

2

RCC

Relative Cell Count

154

0

%

0

%

2022-05-25

3

123

MNvit

GT

A1

3

RPD

Relative Population Doubling

154

0

%

0

%

2022-05-25

4

123

MNvit

GT

A1

4

MNCELLS

Micronucleated Cells

2205

15

Cells

15

Cells

2022-05-25

5

123

MNvit

GT

A1

5

MNCELLS

Micronucleated Cells

2474

13

Cells

13

Cells

2022-05-25

6

123

MNvit

GT

A1

6

MNCELLS

Micronucleated Cells

2758

17

Cells

17

Cells

2022-05-25

7

123

MNvit

GT

A1

7

MNCELLS

Micronucleated Cells

2669

12

Cells

12

Cells

2022-05-25

8

123

MNvit

GT

A1

8

AVGREL

Average Relative MN Frequency

0.57

%

0.57

%

2022-05-25

9

123

MNvit

GT

A2

1

RICC

Relative Increase in Cell Count

134

15.7

%

15.7

%

2022-05-25

10

123

MNvit

GT

A2

2

RCC

Relative Cell Count

134

13.0

%

13.0

%

2022-05-25

11

123

MNvit

GT

A2

3

RPD

Relative Population Doubling

134

7.9

%

7.9

%

2022-05-25

12

123

MNvit

GT

A2

4

MNCELLS

Micronucleated Cells

3266

20

Cells

20

Cells

2022-05-25

13

123

MNvit

GT

A2

5

MNCELLS

Micronucleated Cells

2190

17

Cells

17

Cells

2022-05-25

14

123

MNvit

GT

A2

6

MNCELLS

Micronucleated Cells

2758

13

Cells

13

Cells

2022-05-25

15

123

MNvit

GT

A2

7

MNCELLS

Micronucleated Cells

2714

21

Cells

21

Cells

2022-05-25

16

123

MNvit

GT

A2

8

AVGREL

Average Relative MN Frequency

0.66

%

0.66

%

2022-05-25

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Versions Compared

Old Version 1

New Version Current

Key

SET (what sponsor calls it)