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This example shows a sample report table, trial design, and results dataset for Study #123 study 123 for the determination of the in vitro genotoxicity potential of tobacco products using the in vitro Micronucleus Assay

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-332

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-135

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-127

Expand

title	Sample Report Table for Study 123

Image Removed

micronucleus assay.

Expand

title	Sample Report Table for Study 123

Image Added

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 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

Dataset wrap

Rowcaps

Rows 1-2:	Show two records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP Types apply for this example study.
Row 8:	Shows that the sponsor'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 study director is associated with the Test Facility.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).
Row 17:	Shows the study type for this study.
Row 18:	Shows that this study includes a Mammalian Cell Micronucleus Assay.
Rows 19-20:	Show that the species is human and the cell line is TK6 lymphoblastoid in this study.

Dataset2
Dataset2
	Row	STUDYID	GNTXAID	DOMAIN

Row	STUDYID	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

STSTDTCStudy Start Date2022

	GLPFL	GLP Flag	Y
4	123	TS	1		STSTDTC	Study Start Date	2022-05-25


5	123

NRU

STITLE

Study Title

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


6	123

NRU

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0


7	123

NRU

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30


8	123

NRU

SSPONSOR

APPLCNT

Sponsor Organization

Applicant

Example

Sponsor

Applicant, Inc.


9	123

NRU

SPREFID

APREFID

Sponsor

Study Reference ID

NOT APPLICABLE

123

NRU

TSTFNAM

Test Facility Name

Example Test Lab Name


11	123

NRU

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000


12	123

NRU

TFCNTRY

Test Facility Country

USA


13	123

NRU

STDIR

Study Director

Dr. R. Smith


14	123

NRU

GLPFLOECD

GLP FlagY14123NRUTS1ASTDAssay Standard

TSTGDNAM

Testing Guideline Name

GUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15	123

NRU

ASTDVAssay Standard Version

TSTGDORG

Testing Guideline Organization

OECD

29-July-2016


16	123

NRU

SSTYP

Study TypeGENOTOXICITY IN VITRO

TSTGDVER	Testing Guideline Version	29-July-2016
17	123

NRU

SSSTYP

SSTYP

Study

Sub

Type

MICRONUCLEUS TEST

GENOTOXICITY IN VITRO
18	123

	TS	1		GNTXAID	Genetic Toxicology Assay Identifier	MNvit
19	123

NRU

SPECIES

Species

HUMAN


20	123

NRU

CELLLN

Cell Line

TK6 LYMPHOBLASTOID

This example trial set dataset, tx.xpt, Trial Sets dataset shows information about the test conditions for set A1 and A2 in this example study, 123. Set Sets A1 and A2 can be seen in the first and second rows respectively of Table 1 in the Sample Report table for Study 123 the sample report Table 1 (above). For brevity, the trial sets dataset, tx.xpt, TX dataset and the findings dataset, gt.xpt (GT) dataset do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets.

Dataset wrap

Name	tx

Rows 18-24

Rowcaps

Rows 1-

23:

Show

the experimental

trial set parameters

that are common for Table 1 of Study 123.

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 24-46

Rows 18, 25:

Show that set 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.

:	Show trial set parameters and

trial set

values that comprise the test conditions for trial set

A2. Set

A2 is the data for the

negative control (concentration 0) with

short-term exposure

and

with metabolic activation S9

at a concentration of 1250 ug/ml. The applicant has chosen to

given

give the set a long name (SET) equal to "ST+S9_

C1250".

Set

A2 is associated with the

first

second row in the sample report table for

Study

study 123.

Rows 25-31:

Show trial set parameters and trial set 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.

MNvit

Dataset2

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	TX	A1	ST+S9_C0	1	MTACTIND	Metabolic Activating Agent Name	+S9
2	123	TX	A1	ST+S9_C0	2	METACTFL	Presence of Metabolic Activation Flag	Y
3	123	TX	A1	ST+S9_C0	3	IVTDMIN	In vitro Treatment Duration Minimum	3
4	123	TX	A1	ST+S9_C0	4	IVTDTRG	In vitro Treatment Duration Target	3.5
5	123	TX	A1	ST+S9_C0	5	IVTDMAX	In vitro Treatment Duration Maximum	4
6	123	TX	A1	ST+S9_C0	6	IVTDU	In vitro Treatment Duration Unit	HOURS
7	123	TX	A1	ST+S9_C0	7	RCVDMIN	Recovery Duration Minimum	23.5
8	123	TX	A1	ST+S9_C0	8	RCVDTRG	Recovery Duration Target	24
9	123	TX	A1	ST+S9_C0	9	RCVDMAX	Recovery Duration Maximum	24.5
10	123	TX	A1	ST+S9_C0	10	RCVDU	Recovery Duration Unit	HOURS
11	123	TX	A1	ST+S9_C0	11	INCBTMP	Incubation Temperature	37
12	123	TX	A1	ST+S9_C0	12	INCBTMPU	Incubation Temperature Unit	C
13	123	TX	A1	ST+S9_C0	13	ATMRHP	Atmospheric Relative Humidity Percent	50
14	123	TX	A1	ST+S9_C0	14	ATMCO2P	Atmospheric CO2 Percent	5
15	123	TX	A1	ST+S9_C0	15	SPTOBID	Applicant-defined tobacco identifier	CIG01a
16	123	TX	A1	ST+S9_C0	16	EXPTYP	Exposure Type	Submerged
17	123	TX	A1	ST+S9_C0	17	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	TX	A1	ST+S9_CO	18	ITVNAM	Intervention Article Name	Tobacco ProdA
19	123	TX	A1	ST+S9_C0	19	ITVTYPE	Intervention Article Type	Negative Control
20	123	TX	A1	ST+S9_C0	20	ITVCONC	Intervention Article Concentration	0
21	123	TX	A1	ST+S9_C0	21	ITVCONCU	Intervention Article Concentration Unit	ug/ml
22	123	TX	A1	ST+S9_C0	22	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
23	123	TX	A1	ST+S9_C0	23	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
24	123	TX	A2	ST+S9_C1250	24	MTACTIND	Metabolic Activating Agent Name	+S9
25	123	TX	A2	ST+S9_C1250	25	METACTFL	Presence of Metabolic Activation Flag	Y
26	123	TX	A2	ST+S9_C1250	26	IVTDMIN	In vitro Treatment Duration Minimum	3
27	123	TX	A2	ST+S9_C1250	27	IVTDTRG	In vitro Treatment Duration Target	3.5
28	123	TX	A2	ST+S9_C1250	28	IVTDMAX	In vitro Treatment Duration Maximum	4
29	123	TX	A2	ST+S9_C1250	29	IVTDU	In vitro Treatment Duration Unit	HOURS
30	123	TX	A2	ST+S9_C1250	30	RCVDMIN	Recovery Duration Minimum	23.5
31	123	TX	A2	ST+S9_C1250	31	RCVDTRG	Recovery Duration Target	24
32	123	TX	A2	ST+S9_C1250	32	RCVDMAX	Recovery Duration Maximum	24.5
33	123	TX	A2	ST+S9_C1250	33	RCVDU	Recovery Duration Unit	HOURS
34	123	TX	A2	ST+S9_C1250	34	INCBTMP	Incubation Temperature	37
35	123	TX	A2	ST+S9_C1250	35	INCBTMPU	Incubation Temperature Unit	C
36	123	TX	A2	ST+S9_C1250	36	ATMRHP	Atmospheric Relative Humidity Percent	50
37	123	TX	A2	ST+S9_C1250	37	ATMCO2P	Atmospheric CO2 Percent	5
38	123	TX	A2	ST+S9_C1250	38	SPTOBID	Applicant-defined tobacco identifier	CIG01a
39	123	TX	A2	ST+S9_C1250	39	EXPTYP	Exposure Type	Submerged
40	123

Dataset2

Row

STUDYID

GNTXAID

DOMAIN

SETCD

SET

TXSEQ

TXPARMCD

TXPARM

TXVAL

123

MNvit

ST+S9

METACT

Metabolic Activation

+S9

123

MNvit

ST+S9

METACTFL

Y/N presence of metabolic activation

123

MNvit

ST+S9

TRTDMIN

Treatment Duration Minimum

123

MNvit

ST+S9

TRTDTRG

Treatment Duration Target

3.5

123

MNvit

ST+S9

TRTDMAX

Treatment Duration Maximum

123

MNvit

ST+S9

TRTDU

Treatment Duration Unit

HOURS

123

MNvit

ST+S9

RCVDMIN

Recovery Duration Minimum

23.5

123

MNvit

ST+S9

RCVDTRG

Recovery Duration Target

123

MNvit

ST+S9

RCVDMAX

Recovery Duration Maximum

24.5

123

MNvit

ST+S9

RCVDU

Recovery Duration Unit

HOURS

123

MNvit

ST+S9

INCBTMP

Incubation Temperature

123

MNvit

ST+S9

INCBTMPU

Incubation Temperature Unit

123

MNvit

ST+S9

HUMID

Atmospheric Relative Humidity Percent

123

MNvit

ST+S9

ATMCO2

Atmospheric CO2 Percent

123

MNvit

ST+S9

SPTOBID

Sponsor defined tobacco identifier

CIG01a

123

MNvit

ST+S9

EXPTYP

Exposure Type

Submerged

123

MNvit

ST+S9

SAMTYP

Sample Type

Total Particulate Matter in DMSO

123

MNvit

ST+S9_C0

PSETCD

Parent Set Code

123

MNvit

ST+S9_CO

INTRVN

Name of the Intervention Article

Tobacco ProdA

123

MNvit

ST+S9_C0

ITVTYPE

type of intervention article

Negative Control

123

MNvit

ST+S9_C0

ITVCONC

Concentration of intervention article

123

MNvit

ST+S9_C0

ITVCONCU

Concentration Unit

ug/ml

123

MNvit

ST+S9_C0

SPDEVID

Sponsor defined device identifier

PUFFMASTER3K

123

MNvit

ST+S9_C0

DUREFID

Smoke Regimen

Medium Intensity Regimen

123

ST+S9_C1250

PSETCD

Parent Set Code

A26123

SAMTYP	Sample Type	Total Particulate Matter in DMSO
41	123

MNvitName of the

ST+S9_C1250

2INTRVN

ITVNAM

Intervention Article Name

Tobacco ProdA

123

MNvit

ST+S9_C1250

ITVTYPE

type of intervention article

Intervention Article Type

Product

123

MNvit

ST+S9_C1250

ITVCONC

Intervention Article Concentration

of intervention article

1250

123

MNvit

ST+S9_C1250

ITVCONCU

Intervention Article Concentration Unit

ug/ml

123

MNvit

ST+S9_C1250

SPDEVID

Sponsor defined device identifier

Applicant-defined Device Identifier

PUFFMASTER2023

123

MNvit

ST+S9_C1250

DUREFID

SMKRGM

Smoke

Smoking Regimen

High Intensity Regimen

HIGH INTENSITY REGIMEN

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

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

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

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

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

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