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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. This sample study 


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 is associated with the Test Facility.

ts.xpt

xx.xpt

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123NRUTS1
GLPTYPGood Laboratory Practice TypeFDA
2123NRUTS2
GLPTYPGood Laboratory Practice TypeOECD
3123NRUTS1
STSTDTCStudy Start Date2022-05-25
4123NRUTS1
STITLEStudy Title

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


5123NRUTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123NRUTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123NRUTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
8123NRUTS1
SPREFIDSponsor Study Reference ID
NOT APPLICABLE
9123NRUTS11TSTFNAMTest Facility NameExample Test Lab Name
10123NRUTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123NRUTS11TFCNTRYTest Facility CountryUSA
12123NRUTS11STDIRStudy DirectorDr. R. Smith
13123NRUTS1
GLPFLGLP FlagY
14123NRUTS1
ASTDAssay StandardOECD GUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15123NRUTS1
ASTDVAssay Standard Version29-July-2016
16123NRUTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17123NRUTS1
SSSTYPStudy Sub TypeMICRONUCLEUS TEST
18123NRUTS1
SPECIESSpeciesHUMAN
19123NRUTS1
TESTSYSTest System

TK6 LYMPHOBLASTOID


$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

This example trial set dataset, tx.xpt, shows information about the test conditions for set A1 and A2 in this example study, 123. Set A1 and A2 can be seen in the first and second rows respectively of Table 1 in the Sample Report table for Study 123 (above).  For brevity, the trial sets dataset, tx.xpt, and the findings dataset, gt.xpt 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. 
Rows 1-23:

Show trial set parameters and trial set 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:

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.

tx.xpt

tx.xpt

RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123MNvitTX

A1

ST+S9_C02METACTMetabolic Activation+S9
2123MNvitTXA1ST+S9_C03METACTFLY/N presence of metabolic activationY
3123MNvitTX

A1

ST+S9_C04TRTDMINTreatment Duration Minimum3
4123MNvitTXA1ST+S9_C05TRTDTRGTreatment Duration Target3.5
5123MNvitTXA1ST+S9_C06TRTDMAXTreatment Duration Maximum4
6123MNvitTX

A1

ST+S9_C07TRTDUTreatment Duration UnitHOURS
7123MNvitTXA1ST+S9_C08RCVDMINRecovery Duration Minimum23.5
8123MNvitTXA1ST+S9_C09RCVDTRGRecovery Duration Target24
9123MNvitTX

A1

ST+S9_C010RCVDMAXRecovery Duration Maximum24.5
10123MNvitTXA1ST+S9_C011RCVDURecovery Duration UnitHOURS
11123MNvitTXA1ST+S9_C012INCBTMPIncubation Temperature37
12123MNvitTX

A1

ST+S9_C013INCBTMPUIncubation Temperature UnitC
13123MNvitTXA1ST+S9_C014HUMIDAtmospheric Relative Humidity Percent50
14123MNvitTX

A1

ST+S9_C015ATMCO2Atmospheric CO2 Percent5
15123MNvitTXA1ST+S9_C016

SPTOBID

Sponsor defined tobacco identifier

CIG01a
16123MNvitTXA1ST+S9_C017EXPTYP

Exposure Type

Submerged
17123MNvitTXA1ST+S9_C018SAMTYP

Sample Type

Total Particulate Matter in DMSO
18123MNvitTXA1ST+S9_C019INTRVN

Name of the Intervention Article

Tobacco ProdA
19123MNvitTXA1ST+S9_C020ITVTYPE

type of intervention article

Negative Control
20123MNvitTXA1ST+S9_C021ITVCONCConcentration of intervention article0
21123MNvitTXA1ST+S9_C022ITVCONCUConcentration Unitug/ml
22123MNvitTXA1ST+S9_C023

SPDEVID

Sponsor defined device identifierPUFFMASTER3K
23123MNvitTXA1ST+S9_C024

DUREFID

Smoke RegimenMedium Intensity Regimen
24123MNvitTX

A2

ST+S9_C12502METACTMetabolic Activation+S9
25123MNvitTXA2ST+S9_C12503METACTFLY/N presence of metabolic activationY
26123MNvitTXA2ST+S9_C12504TRTDMINTreatment Duration Minimum3
27123MNvitTXA2ST+S9_C12505TRTDTRGTreatment Duration Target3.5
28123MNvitTXA2ST+S9_C12506TRTDMAXTreatment Duration Maximum4
29123MNvitTXA2ST+S9_C12507TRTDUTreatment Duration UnitHOURS
30123MNvitTXA2ST+S9_C12508RCVDMINRecovery Duration Minimum23.5
31123MNvitTXA2ST+S9_C12509RCVDTRGRecovery Duration Target24
32123MNvitTXA2ST+S9_C125010RCVDMAXRecovery Duration Maximum24.5
33123MNvitTXA2ST+S9_C125011RCVDURecovery Duration UnitHOURS
34123MNvitTXA2ST+S9_C125012INCBTMPIncubation Temperature37
35123MNvitTXA2ST+S9_C125013INCBTMPUIncubation Temperature UnitC
36123MNvitTXA2ST+S9_C125014HUMIDAtmospheric Relative Humidity Percent50
37123MNvitTXA2ST+S9_C125015ATMCO2Atmospheric CO2 Percent5
38123MNvitTXA2ST+S9_C125016SPTOBID

Sponsor defined tobacco identifier

CIG01a
39123MNvitTXA2ST+S9_C125017EXPTYP

Exposure Type

Submerged
40123MNvitTXA2ST+S9_C125018SAMTYP

Sample Type

Total Particulate Matter in DMSO
41123MNvitTXA2ST+S9_C125019INTRVN

Name of the Intervention Article

Tobacco ProdA
42123MNvitTXA2ST+S9_C125020ITVTYPE

type of intervention article

Product
43123MNvitTXA2ST+S9_C125021ITVCONCConcentration of intervention article1250
44123MNvitTXA2ST+S9_C125022ITVCONCUConcentration Unitug/ml
45123MNvitTXA2ST+S9_C125023SPDEVIDSponsor defined device identifierPUFFMASTER2023
46123MNvitTXA2ST+S9_C125024DUREFIDSmoke 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 trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='EXPERIMENTAL UNIT/TRIAL SET' indicates this identifier is referring to both the experimental unit, the unit to which the treatment is applied, and the entire trial set.
Rows 2-5:Show the values of four observational units C0_Count1 through C0_Count4 that are within the parent experimental unit, REFID=C0, and in this example assay these observational units are also all within the same trial set, as defined in the trial set dataset, tx.xpt.
Row 6:Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of 'A2', as defined in the trial set dataset, tx.xpt. LEVEL=1 and LVLDESC='EXPERIMENTAL UNIT/TRIAL SET' indicates this identifier is referring to both the experimental unit, the unit to which the treatment is applied, and the entire trial set.
Rows 7-10:Show the values of four observational units C1250_Count1 through C1250_Count4 that are within the parent experimental unit, REFID=C0, and in this example assay these observational units are also all within the same trial set, as defined in the trial set dataset, tx.xpt.
$titleHtml

relref.xpt

Row

STUDYID

GNTXAID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

123

MNvit

A1

C0
1

EXPERIMENTAL UNIT/TRIAL SET

2

123

MNvit

A1

C0-Count1C02OBSERVATIONAL UNIT

3

123

MNvit

A1

C0-Count2C02OBSERVATIONAL UNIT

4

123

MNvit

A1

C0-Count3C02OBSERVATIONAL UNIT

5

123

MNvit

A1

C0-Count4C02OBSERVATIONAL UNIT

6

123

MNvit

A2C1250
1EXPERIMENTAL UNIT/TRIAL SET
7123

MNvit

A2C1250-Count1C12502OBSERVATIONAL UNIT
8123

MNvit

A2C1250-Count2C12502OBSERVATIONAL UNIT
9123

MNvit

A2C1250-Count3C12502OBSERVATIONAL UNIT
10123

MNvit

A2C1250-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 REFID=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 four micronucleated cell counts for the observational units with REFID 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 REFID=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 four micronucleated cell counts for the observational units with REFID 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.

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

gt.xpt

gt.xpt

RowSTUDYIDGNTXAIDDOMAIN

REFID

GTSEQGTTESTCDGTTESTGTCELLEVGTORRESGTORRESU

GTCOLSRT

GTSTRESCGTSTRESNGTSTRESUGTDTC
1123MNvitGTC01RICCRelative Increase in Cell Count1540%
00%2022-05-25
2123MNvitGTC02RCCRelative Cell Count1540%
00%2022-05-25
3123MNvitGTC03RPDRelative Population Doubling1540%
00%2022-05-25
4123MNvitGTC0-Count14MNCELLSMicronucleated Cells220515Cells
1515Cells2022-05-25
5123MNvitGTC0-Count25MNCELLSMicronucleated Cells247413Cells
1313Cells2022-05-25
6123MNvitGTC0-Count36MNCELLSMicronucleated Cells275817Cells
1717Cells2022-05-25
7123MNvitGTC0-Count47MNCELLSMicronucleated Cells266912Cells
1212Cells2022-05-25
8123MNvitGTC08AVGRELAverage Relative MN Frequency
0.57%
0.570.57%2022-05-25
9123MNvitGTC12501RICCRelative Increase in Cell Count13415.7%
15.715.7%2022-05-25
10123MNvitGTC12502RCCRelative Cell Count13413.0%
13.013.0%2022-05-25
11123MNvitGTC12503RPDRelative Population Doubling1347.9%
7.97.9%2022-05-25
12123MNvitGTC1250-Count14MNCELLSMicronucleated Cells326620Cells
2020Cells2022-05-25
13123MNvitGTC1250-Count25MNCELLSMicronucleated Cells219017Cells
1717Cells2022-05-25
14123MNvitGTC1250-Count36MNCELLSMicronucleated Cells275813Cells
1313Cells2022-05-25
15123MNvitGTC1250-Count47MNCELLSMicronucleated Cells271421Cells
2121Cells2022-05-25
16123MNvitGTC12508AVGRELAverage Relative MN Frequency
0.66%
0.660.66%2022-05-25
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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