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This example shows a sample report table, trial design, and results dataset for study 123 for the determination of the in vitro genotoxicity potential of tobacco products using the in vitro micronucleus assay.  TOBA-642 - Getting issue details... STATUS

TOBA-456 - Getting issue details... STATUS

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 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). TOBA-56 - Jira project doesn't exist or you don't have permission to view it.

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.

ts.xpt

xx.xpt

Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123TS1
GLPTYPGood Laboratory Practice TypeFDA
2123TS2
GLPTYPGood Laboratory Practice TypeOECD
3123TS1
GLPFLGLP FlagY
4123TS1
STSTDTCStudy Start Date2022-05-25
5123TS1
STITLEStudy Title

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


6123TS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
7123TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
8123TS1
APPLCNT

Applicant Organization TOBA-356 - Jira project doesn't exist or you don't have permission to view it.

Example Applicant, Inc.
9123TS1
APREFIDStudy Reference ID
NOT APPLICABLE
10123TS11TSTFNAMTest Facility NameExample Test Lab Name
11123TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
12123TS11TFCNTRYTest Facility CountryUSA
13123TS11STDIRStudy DirectorDr. R. Smith
14123TS12TSTGDNAMTesting Guideline NameGUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15123TS12TSTGDORGTesting Guideline OrganizationOECD
16123TS12TSTGDVERTesting Guideline Version29-July-2016
17123TS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
18123TS1
GNTXAIDGenetic Toxicology Assay IdentifierMNvit
19123TS1
SPECIESSpeciesHUMAN
20123TS1
CELLLNCell Line

TK6 LYMPHOBLASTOID


Dataset Debug Messages

  • When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.
  • Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

This example Trial Sets dataset shows information about the test conditions for set A1 and A2 in this example study. Sets A1 and A2 can be seen in the first and second rows respectively of the sample report Table 1 (above). For brevity, the TX dataset and the findings (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.  TOBA-457 - Getting issue details... STATUS
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.

tx.xpt

tx.xpt

RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL

1

123TXAST+S9

1

METACTINDMetabolic Activating Agent Name+S9
2123TXAST+S92METACTFLPresence of Metabolic Activation FlagY
3123TXAST+S93

IVTDMIN

In vitro Treatment Duration Minimum3
4123TXAST+S94IVTDTRGIn vitro Treatment Duration Target3.5
5123TXAST+S95IVTDMAXIn vitro Treatment Duration Maximum4
6123TXAST+S96IVTDUIn vitro Treatment Duration UnitHOURS
7123TXAST+S97RCVDMINRecovery Duration Minimum23.5
8123TXAST+S98RCVDTRGRecovery Duration Target24
9123TXAST+S99RCVDMAXRecovery Duration Maximum24.5
10123TXAST+S910RCVDURecovery Duration UnitHOURS
11123TXAST+S911INCBTMPIncubation Temperature37
12123TXAST+S912INCBTMPUIncubation Temperature UnitC
13123TXAST+S913ATMRHPAtmospheric Relative Humidity Percent50
14123TXAST+S914ATMCO2PAtmospheric CO2 Percent5
15123TXAST+S915

SPTOBID

Applicant-defined tobacco identifier

CIG01a
16123TXAST+S916EXPTYP

Exposure Type

Submerged
17123TXAST+S917SAMTYP

Sample Type

Total Particulate Matter in DMSO
18123TXA1ST+S9_C0

1

PSETCD

Parent Set Code

A
19123TXA1ST+S9_CO2ITVNAM

Intervention Article Name

Tobacco ProdA
20123TXA1ST+S9_C03ITVTYPE

Intervention Article Type

Negative Control
21123TXA1ST+S9_C04ITVCONCIntervention Article Concentration0
22123TXA1ST+S9_C05ITVCONCUIntervention Article Concentration Unitug/ml
23123TXA1ST+S9_C06

SPDEVID

Applicant-defined device identifierPUFFMASTER3K
24123TXA1ST+S9_C07

SMKRGM

Smoking RegimenMEDIUM INTENSITY REGIMEN
25123TXA2ST+S9_C1250

1

PSETCD

Parent Set Code

A
26123TXA2ST+S9_C12502ITVNAM

Intervention Article Name

Tobacco ProdA
27123TXA2ST+S9_C12503ITVTYPE

Intervention Article Type

Product
28123TXA2ST+S9_C12504ITVCONCIntervention Article Concentration1250
29123TXA2ST+S9_C12505ITVCONCUIntervention Article Concentration Unitug/ml
30123TXA2ST+S9_C12506SPDEVIDApplicant-defined Device IdentifierPUFFMASTER2023
31123TXA2ST+S9_C12507

SMKRGM

Smoking RegimenHIGH INTENSITY REGIMEN
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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) 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.

$titleHtml

relref.xpt

Row

STUDYID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

123

A1

C0
1

EXPERIMENTAL UNIT/TRIAL SET

2

123

A1

C0-Count1C02OBSERVATIONAL UNIT

3

123

A1

C0-Count2C02OBSERVATIONAL UNIT

4

123

A1

C0-Count3C02OBSERVATIONAL UNIT

5

123

A1

C0-Count4C02OBSERVATIONAL UNIT

6

123A2C1250
1EXPERIMENTAL UNIT/TRIAL SET
7123A2C1250-Count1C12502OBSERVATIONAL UNIT
8123A2C1250-Count2C12502OBSERVATIONAL UNIT
9123A2C1250-Count3C12502OBSERVATIONAL UNIT
10123A2C1250-Count4C12502OBSERVATIONAL UNIT
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

gt.xpt

gt.xpt

RowSTUDYIDDOMAIN

GTREFID

GTSEQGTTESTCDGTTESTGTCELLEVGTORRESGTORRESU

GTCOLSRT

GTSTRESCGTSTRESNGTSTRESUGTDTC
1123GTC01

RICC TOBA-643 - Jira project doesn't exist or you don't have permission to view it.

Relative Increase in Cell Count1540%
00%2022-05-25
2123GTC02RCCRelative Cell Count1540%
00%2022-05-25
3123GTC03RPDRelative Population Doubling1540%
00%2022-05-25
4123GTC0-Count14MNCEMicronucleated Cells220515

1515
2022-05-25
5123GTC0-Count25MNCEMicronucleated Cells247413

1313
2022-05-25
6123GTC0-Count36MNCEMicronucleated Cells275817

1717
2022-05-25
7123GTC0-Count47MNCEMicronucleated Cells266912

1212
2022-05-25
8123GTC08MNCECEMicronucleated Cells/Total Cells
0.57%
0.570.57%2022-05-25
9123GTC12501RICCRelative Increase in Cell Count13415.7%
15.715.7%2022-05-25
10123GTC12502RCCRelative Cell Count13413.0%
13.013.0%2022-05-25
11123GTC12503RPDRelative Population Doubling1347.9%
7.97.9%2022-05-25
12123GTC1250-Count14MNCEMicronucleated Cells326620

2020
2022-05-25
13123GTC1250-Count25MNCEMicronucleated Cells219017

1717
2022-05-25
14123GTC1250-Count36MNCEMicronucleated Cells275813

1313
2022-05-25
15123GTC1250-Count47MNCEMicronucleated Cells271421

2121
2022-05-25
16123GTC12508MNCECE

Micronucleated Cells/Total Cells


0.66%
0.660.66%2022-05-25

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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