Page History

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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 example 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=2) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-56

Dataset2

MICRONUCLEUS TEST

Row

STUDYID

GNTXAID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1

123

NRU

TS

1

GLPTYP

Good Laboratory Practice Type

FDA

2

123

NRU

TS

2

GLPTYP

Good Laboratory Practice Type

OECD

3

123

NRU

TS

1

STSTDTC

Study Start Date

2022-05-25

4

123

NRU

TS

1

STITLE

Study Title

Determination of the in vitro genotoxicity potential using the in vitro Neutral Red Uptake assay

5

123

NRU

TS

1

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0

6

123

NRU

TS

1

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30

7

123

NRU

TS

1

APPLCNT

Applicant Organization

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-356

Example Applicant, Inc.

8

123

NRU

TS

1

APREFID

Study Reference ID

NOT APPLICABLE

9

123

NRU

TS

1

TSTFNAM

Test Facility Name

Example Test Lab Name

10

123

NRU

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

11

123

NRU

TS

1

TFCNTRY

Test Facility Country

USA

12

123

NRU

TS

1

STDIR

Study Director

Dr. R. Smith

13

123

NRU

TS

1

GLPFL

GLP Flag

Y

14

123

NRU

TS

1

2

TSTGDNAM

Testing Guideline Name

GUIDELINE FOR THE TESTING OF CHEMICALS No. 487

15

123

NRU

TS

1

2

TSTGDORG

Testing Guideline Organization

OECD

16

123

NRU

TS

1

2

TSTGDVER

Testing Guideline Version

29-July-2016

17

123

NRU

TS

1

SSTYP

Study Type

GENOTOXICITY IN VITRO

18

123

NRU

TS

1

SSSTYP

Study Sub Type

GNTXAID

Genetic Toxicology Assay Identifier

MNvit

19

123

NRU

TS

1

SPECIES

Species

HUMAN

20

123

NRU

TS

1

CELLLN

Cell Line

TK6 LYMPHOBLASTOID

...

Dataset wrap

Name	tx

Rowcaps

Rows 1-17:	Show the experimental parameters that are common for table 1 of study 123.
Rows 18, 25:	Show that sets A1 and A2 each have a parent set code of A. As a child of set A, each of these sets inherit the test conditions of set A.
Rows 18-24:	Show trial set parameters and values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short-term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0". Set A1 is associated with the first row in the sample report table for study 123.
Rows 25-31:	Show trial set parameters and values that comprise the test conditions for trial set A2. Set A2 is the data for the short-term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250". Set A2 is associated with the second row in the sample report table for study 123.

Dataset2

Row	STUDYID	GNTXAID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	MNvit	TX	A	ST+S9	1	METACTIND	Metabolic Activating Agent Name	+S9
2	123MNvit	TX	A	ST+S9	2	METACTFL	Presence of Metabolic Activation Flag	Y
3	123MNvit	TX	A	ST+S9	3	IVTDMIN	In vitro Treatment Duration Minimum	3
4	123	MNvit	TX	A	ST+S9	4	IVTDTRG	In vitro Treatment Duration Target	3.5
5	123MNvit	TX	A	ST+S9	5	IVTDMAX	In vitro Treatment Duration Maximum	4
6	123MNvit	TX	A	ST+S9	6	IVTDU	In vitro Treatment Duration Unit	HOURS
7	123	MNvit	TX	A	ST+S9	7	RCVDMIN	Recovery Duration Minimum	23.5
8	123	MNvit	TX	A	ST+S9	8	RCVDTRG	Recovery Duration Target	24
9	123	MNvit	TX	A	ST+S9	9	RCVDMAX	Recovery Duration Maximum	24.5
10	123	MNvit	TX	A	ST+S9	10	RCVDU	Recovery Duration Unit	HOURS
11	123	MNvit	TX	A	ST+S9	11	INCBTMP	Incubation Temperature	37
12	123MNvit	TX	A	ST+S9	12	INCBTMPU	Incubation Temperature Unit	C
13	123	MNvit	TX	A	ST+S9	13	ATMRHP	Atmospheric Relative Humidity Percent	50
14	123	MNvit	TX	A	ST+S9	14	ATMCO2P	Atmospheric CO2 Percent	5
15	123MNvit	TX	A	ST+S9	15	SPTOBID	Applicant-defined tobacco identifier	CIG01a
16	123	MNvit	TX	A	ST+S9	16	EXPTYP	Exposure Type	Submerged
17	123	MNvit	TX	A	ST+S9	17	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	MNvit	TX	A1	ST+S9_C0	1	PSETCD	Parent Set Code	A
19	123	MNvit	TX	A1	ST+S9_CO	2	ITVNAM	Intervention Article Name	Tobacco ProdA
20	123	MNvit	TX	A1	ST+S9_C0	3	ITVTYPE	Intervention Article Type	Negative Control
21	123MNvit	TX	A1	ST+S9_C0	4	ITVCONC	Intervention Article Concentration	0
22	123	MNvit	TX	A1	ST+S9_C0	5	ITVCONCU	Intervention Article Concentration Unit	ug/ml
23	123	MNvit	TX	A1	ST+S9_C0	6	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
24	123	MNvit	TX	A1	ST+S9_C0	7	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
25	123	MNvit	TX	A2	ST+S9_C1250	1	PSETCD	Parent Set Code	A
26	123MNvit	TX	A2	ST+S9_C1250	2	ITVNAM	Intervention Article Name	Tobacco ProdA
27	123MNvit	TX	A2	ST+S9_C1250	3	ITVTYPE	Intervention Article Type	Product
28	123	MNvit	TX	A2	ST+S9_C1250	4	ITVCONC	Intervention Article Concentration	1250
29	123	MNvit	TX	A2	ST+S9_C1250	5	ITVCONCU	Intervention Article Concentration Unit	ug/ml
30	123MNvit	TX	A2	ST+S9_C1250	6	SPDEVID	Applicant-defined Device Identifier	PUFFMASTER2023
31	123MNvit	TX	A2	ST+S9_C1250	7	SMKRGM	Smoking Regimen	HIGH INTENSITY REGIMEN

Dataset wrap

Name	relref

Rowcaps

Row 1:

Shows the value of REFID=C0. This REFID refers to the trial set with a SETCD of "A1", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.

Rows 2-5:

Show the values of 4 observational units (C0_Count1 through C0_Count4) that are within the parent experimental unit, REFID=C0. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.

Row 6:

Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of "A2", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.

Rows 7-10:

Show the values of 4 observational units (C1250_Count1 through C1250_Count4)

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-687

that are within the parent experimental unit, REFID=C1250. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.

Dataset2

tableid	relref

Row	STUDYIDGNTXAID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123MNvit	A1	C0		1	EXPERIMENTAL UNIT/TRIAL SET
2	123MNvit	A1	C0-Count1	C0	2	OBSERVATIONAL UNIT
3	123	MNvit	A1	C0-Count2	C0	2	OBSERVATIONAL UNIT
4	123MNvit	A1	C0-Count3	C0	2	OBSERVATIONAL UNIT
5	123	MNvit	A1	C0-Count4	C0	2	OBSERVATIONAL UNIT
6	123	MNvit	A2	C1250		1	EXPERIMENTAL UNIT/TRIAL SET
7	123	MNvit	A2	C1250-Count1	C1250	2	OBSERVATIONAL UNIT
8	123MNvit	A2	C1250-Count2	C1250	2	OBSERVATIONAL UNIT
9	123	MNvit	A2	C1250-Count3	C1250	2	OBSERVATIONAL UNIT
10	123MNvit	A2	C1250-Count4	C1250	2	OBSERVATIONAL UNIT

Dataset wrap

Name	gt

Rowcaps

Rows 1-3, 8:	Show percentage result values that apply to GTREFID=C0. REFID=C0, as shown in the RELREF dataset, relates this data to the trial set in the first row of table 1 in the sample report table for study 123.
Rows 4-7:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C0-Count1 through C0-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.
Rows 9-11, 16:	Show percentage result values that apply to GTREFID=C1250. REFID=C1250, as shown in the RELREF dataset, relates this data to the trial set in the second row of table 1 in the sample report table for study 123.
Rows 12-15:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C1250-Count1 through C1250-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.

Dataset2

Row	STUDYID

GNTXAID

	DOMAIN	GTREFID	GTSEQ	GTTESTCD	GTTEST	GTCELLEV	GTORRES	GTORRESU	GTCOLSRT	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC
1	123

MNvit

GT

C0

1

RICC

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-643

Relative Increase in Cell Count

154

0

%

0

%

2022-05-25

2

123

MNvit

GT	C0	2	RCC	Relative Cell Count	154	0	%		0	0	%	2022-05-25
3	123

MNvit

GT	C0	3	RPD	Relative Population Doubling	154	0	%		0	0	%	2022-05-25
4	123

MNvit

	GT	C0-Count1	4	MNCE	Micronucleated Cells	2205	15	Cells		15	15	Cells	2022-05-25
5	123

MNvit

GT	C0-Count2	5	MNCE	Micronucleated Cells	2474	13	Cells		13	13	Cells	2022-05-25
6	123

MNvit

	GT	C0-Count3	6	MNCE	Micronucleated Cells	2758	17	Cells		17	17	Cells	2022-05-25
7	123

MNvit

	GT	C0-Count4	7	MNCE	Micronucleated Cells	2669	12	Cells		12	12	Cells	2022-05-25
8	123

MNvit

GT	C0	8	MNCECE	Micronucleated Cells/Total Cells		0.57	%		0.57	0.57	%	2022-05-25
9	123

MNvit

	GT	C1250	1	RICC	Relative Increase in Cell Count	134	15.7	%		15.7	15.7	%	2022-05-25
10	123

MNvit

	GT	C1250	2	RCC	Relative Cell Count	134	13.0	%		13.0	13.0	%	2022-05-25
11	123

MNvit

	GT	C1250	3	RPD	Relative Population Doubling	134	7.9	%		7.9	7.9	%	2022-05-25
12	123

MNvit

GT	C1250-Count1	4	MNCE	Micronucleated Cells	3266	20	Cells		20	20	Cells	2022-05-25
13	123

MNvit

	GT	C1250-Count2	5	MNCE	Micronucleated Cells	2190	17	Cells		17	17	Cells	2022-05-25
14	123

MNvit

	GT	C1250-Count3	6	MNCE	Micronucleated Cells	2758	13	Cells		13	13	Cells	2022-05-25
15	123

MNvit

GT	C1250-Count4	7	MNCE	Micronucleated Cells	2714	21	Cells		21	21	Cells	2022-05-25
16	123

MNvit

GT

C1250

8

MNCECE

Micronucleated Cells/Total Cells

0.66

%

0.66

%

2022-05-25

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