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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.  JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyTOBA-642

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titleSample Report Table for Study 123

...

Dataset wrap

...

showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-456
Rowcaps
Rows 1-2:Show 2 records for TSPARMCD =
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 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
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-56

Row 17:

Shows the study type for this study.

Row 17:

Shows the study type for this study.

Row 18:

Shows that 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
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

Example Applicant Organization, Inc.jira
9showSummary123falseTS
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-356
Example Applicant, Inc.1
9123TS1APREFIDStudy 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


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. 

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-457
study would include information about the test conditions and findings for all sets. 

Dataset wrap
Nametx
Rowcaps
Rows 1-23
Dataset wrap
Nametx
Rows 18-24
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.

:

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
24-
31
46:

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
RowSTUDYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123TXA1ST+S9_C01METACTINDMTACTINDMetabolic Activating Agent Name+S9
2123TXA1ST+S9_C02METACTFLPresence of Metabolic Activation FlagY
3123TXA1ST+S9_C03

IVTDMIN

In vitro Treatment Duration Minimum3
4123TXA1ST+S9_C04IVTDTRGIn vitro Treatment Duration Target3.5
5123TXA1ST+S9_C05IVTDMAXIn vitro Treatment Duration Maximum4
6123TXA1ST+S9_C06IVTDUIn vitro Treatment Duration UnitHOURS
7123TXA1ST+S9_C07RCVDMINRecovery Duration Minimum23.5
8123TXA1ST+S9_C08RCVDTRGRecovery Duration Target24
9123TXA1ST+S9_C09RCVDMAXRecovery Duration Maximum24.5
10123TXA1ST+S9_C010RCVDURecovery Duration UnitHOURS
11123TXA1ST+S9_C011INCBTMPIncubation Temperature37
12123TXA1ST+S9_C012INCBTMPUIncubation Temperature UnitC
13123TXA1ST+S9_C013ATMRHPAtmospheric Relative Humidity Percent50
14123TXA1ST+S9_C014ATMCO2PAtmospheric CO2 Percent5
15123TXA1ST+S9_C015

SPTOBID

Applicant-defined tobacco identifier

CIG01a
16123TXA1ST+S9_C016EXPTYP

Exposure Type

Submerged
17123TXA1ST+S9_C017SAMTYP

Sample Type

Total Particulate Matter in DMSO
18123TXA1ST+S9_CO18ITVNAM

Intervention Article Name

Tobacco ProdA
19123TXA1ST+S9_C019ITVTYPE

Intervention Article Type

Negative Control
20123TXA1ST+S9_C020ITVCONCIntervention Article Concentration0
21123TXA1ST+S9_C021ITVCONCUIntervention Article Concentration Unitug/ml
22123TXA1ST+S9_C022

SPDEVID

Applicant-defined device identifierPUFFMASTER3K
23123TXA1ST+S9_C023

SMKRGM

Smoking RegimenMEDIUM INTENSITY REGIMEN
24123TXA2ST+S9_C125024METACTINDMTACTINDMetabolic Activating Agent Name+S9
25123TXA2ST+S9_C125025METACTFLPresence of Metabolic Activation FlagY
26123TXA2ST+S9_C125026

IVTDMIN

In vitro Treatment Duration Minimum3
27123TXA2ST+S9_C125027IVTDTRGIn vitro Treatment Duration Target3.5
28123TXA2ST+S9_C125028IVTDMAXIn vitro Treatment Duration Maximum4
29123TXA2ST+S9_C125029IVTDUIn vitro Treatment Duration UnitHOURS
30123TXA2ST+S9_C125030RCVDMINRecovery Duration Minimum23.5
31123TXA2ST+S9_C125031RCVDTRGRecovery Duration Target24
32123TXA2ST+S9_C125032RCVDMAXRecovery Duration Maximum24.5
33123TXA2ST+S9_C125033RCVDURecovery Duration UnitHOURS
34123TXA2ST+S9_C125034INCBTMPIncubation Temperature37
35123TXA2ST+S9_C125035INCBTMPUIncubation Temperature UnitC
36123TXA2ST+S9_C125036ATMRHPAtmospheric Relative Humidity Percent50
37123TXA2ST+S9_C125037ATMCO2PAtmospheric CO2 Percent5
38123TXA2ST+S9_C125038

SPTOBID

Applicant-defined tobacco identifier

CIG01a
39123TXA2ST+S9_C125039EXPTYP

Exposure Type

Submerged
40123TXA2ST+S9_C125040SAMTYP

Sample Type

Total Particulate Matter in DMSO
41123TXA2ST+S9_C125041ITVNAM

Intervention Article Name

Tobacco ProdA
42123TXA2ST+S9_C125042ITVTYPE

Intervention Article Type

Product
43123TXA2ST+S9_C125043ITVCONCIntervention Article Concentration1250
44123TXA2ST+S9_C125044ITVCONCUIntervention Article Concentration Unitug/ml
45123TXA2ST+S9_C125045SPDEVIDApplicant-defined Device IdentifierPUFFMASTER2023
46123TXA2ST+S9_C125046

SMKRGM

Smoking RegimenHIGH INTENSITY REGIMEN

...

Dataset wrap
Namegt
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
TOBA-643

TOBA-756
RowSTUDYIDDOMAINGTSEQ

GTREFID

GTTESTCDGTTESTGTCELLEVGTORRESGTORRESU

GTCOLSRT

GTSTRESCGTSTRESNGTSTRESUGTDTCGTDTC
1123GT1C0

RICC

1123GT1C0

RICC

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyRelative Increase in Cell Count1540%
00%2022-05-25
2123GT2C0RCCRelative Cell Count1540%
00%2022-05-25
3123GT3C0RPDRelative Population Doubling1540%
00%2022-05-25
4123GT4C0-Count1MNCEMicronucleated Cells220515
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key



1515
2022-05-25
5123GT5C0-Count2MNCEMicronucleated Cells247413

1313
2022-05-25
6123GT6C0-Count3MNCEMicronucleated Cells275817

1717
2022-05-25
7123GT7C0-Count4MNCEMicronucleated Cells266912

1212
2022-05-25
8123GT8C0MNCECEMicronucleated Cells/Total Cells
0.57%
0.570.57%2022-05-25
9123GT1C1250RICCRelative Increase in Cell Count13415.7%
15.715.7%2022-05-25
10123GT2C1250RCCRelative Cell Count13413.0%
13.013.0%2022-05-25
11123GT3C1250RPDRelative Population Doubling1347.9%
7.97.9%2022-05-25
12123GT4C1250-Count1MNCEMicronucleated Cells326620

2020
2022-05-25
13123GT5C1250-Count2MNCEMicronucleated Cells219017

1717
2022-05-25
14123GT6C1250-Count3MNCEMicronucleated Cells275813

1313
2022-05-25
15123GT7C1250-Count4MNCEMicronucleated Cells271421

2121
2022-05-25
16123GT8C1250MNCECE

Micronucleated Cells/Total Cells


0.66%
0.660.66%2022-05-25