You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 8 Next »

This is an example showing trial design and results data of Study #123 for the determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay





Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1
TS1
SSTYPStudy TypeREPEAT DOSE TOXICITY
2
TS1
SPECIESSpeciesRAT
3
TS1
STRAINStrain/SubstrainFISCHER 344
4
TS1
SPLRNAMTest Subject SupplierHARLAN
5
TS1
SDESIGNStudy DesignCROSSOVER
6
TS1
ROUTERoute of AdministrationORAL
7
TS1
GLPTYPGood Laboratory Practice TypeFDA
8
TS1
EXPSTDTCExperimental Start Date2008-01-01
9
TS1
EXPENDTCExperimental End Date2008-03-07
10
TS1
TRMSACTime to Terminal SacrificeP42D
11
TS1
STSTDTCStudy Start Date2007-12-30
12
TS1
DOSDURDosing DurationP42D
13
TS1
STITLEStudy TitleExample of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14
TS1
SNDIGVERSEND Implementation Guide VersionSEND IMPLEMENTATION GUIDE VERSION 3.2
15
TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-03-26
16
TS1
STCATStudy CategoryTOX
17
TS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
18
TS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
19
TS11TSTFNAMTest Facility NameExample Tox Lab Name
20
TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
21
TS11TFCNTRYTest Facility CountryUSA
22
TS1
AGETXTAge Text6-8
23
TS1
AGEUAge UnitWEEKS
24
TS11STDIRStudy DirectorDr. R. Smith
25
TS1
TRTInvestigational Therapy or TreatmentDrug A
26
TS12TRTVTreatment VehicleSaline
27
TS12TRTVDESCTreatment Vehicle Structured Description100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}
28
TS1
GLPFLGLP FlagY
29
TS1
TRTCASPrimary Treatment CAS Registry Number
TEMPORARILY UNAVAILABLE

Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1
TS1
SSTYPStudy TypeREPEAT DOSE TOXICITY
2
TS1
SPECIESSpeciesRAT
3
TS1
STRAINStrain/SubstrainFISCHER 344
4
TS1
SPLRNAMTest Subject SupplierHARLAN
5
TS1
SDESIGNStudy DesignCROSSOVER
6
TS1
ROUTERoute of AdministrationORAL
7
TS1
GLPTYPGood Laboratory Practice TypeFDA
8
TS1
EXPSTDTCExperimental Start Date2008-01-01
9
TS1
EXPENDTCExperimental End Date2008-03-07
10
TS1
TRMSACTime to Terminal SacrificeP42D
11
TS1
STSTDTCStudy Start Date2007-12-30
12
TS1
DOSDURDosing DurationP42D
13
TS1
STITLEStudy TitleExample of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14
TS1
SNDIGVERSEND Implementation Guide VersionSEND IMPLEMENTATION GUIDE VERSION 3.2
15
TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-03-26
16
TS1
STCATStudy CategoryTOX
17
TS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
18
TS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
19
TS11TSTFNAMTest Facility NameExample Tox Lab Name
20
TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
21
TS11TFCNTRYTest Facility CountryUSA
22
TS1
AGETXTAge Text6-8
23
TS1
AGEUAge UnitWEEKS
24
TS11STDIRStudy DirectorDr. R. Smith
25
TS1
TRTInvestigational Therapy or TreatmentDrug A
26
TS12TRTVTreatment VehicleSaline
27
TS12TRTVDESCTreatment Vehicle Structured Description100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}
28
TS1
GLPFLGLP FlagY
29
TS1
TRTCASPrimary Treatment CAS Registry Number
TEMPORARILY UNAVAILABLE




RowSTUDYIDASSAYIDDOMAINARMCDARMTAETORDETCDELEMENT




































1

TAARM01-Prod1Cigarette Smoke Condensate, 10 ug/mL1TREATMTTreatment
9


9SLS-1101

RowSTUDYIDASSAYIDDOMAINETCDELEMENT



TETREATMTTreatment

Red font (CT is coming!, POSITIVE CONTROL, VEHICLE CONTROL, etc.)

ARMCD.      TREATMENT (element).       SETCD

ARM01             TREATMT.                                CS-01. (Cigarette Smoke 10 ug/mL)

ARM01

TA.XPT

TRIAL ARMS

RowSTUDYIDASSAYIDDOMAINARMCDARMTAETORDETCDELEMENT













































1

TAARM01-Prod1Cigarette Smoke Condensate, 10 ug/mL1TREATMTTreatment
2

TAARM02-Prod1Cigarette Smoke Condensate, 50 ug/mL1TREATMTTreatment
3

TAARM03-Prod1Cigarette Smoke Condensate, 75 ug/mL1TREATMTTreatment
4

TA4
1

5

TA5
1

6

TA6
1

7


7
1

8


8
1

9


9SLS-1101

10


ARM10SLS-2001


TE.XPT

TRIAL ELEMENTS

RowSTUDYIDASSAYIDDOMAINETCDELEMENT



TETREATMTTreatment


tx.spt

TRIAL SET

example: Each plate has a separate product

Product, Smoking Regime (e.g. Traditional combustible, ENDS), Smoke Fraction, etc.

https://www.itis.gov/servlet/SingleRpt/SingleRpt?search_topic=TSN&search_value=969610#null


One study (Original sample of TK6 cells);  (6 rows in GT)
   

                 Assay (MNT) (ran on 10 tobacco products)
                      3 assay/test conditions; 
                             Treatment duration (2: ST, LT);
                             Presence of metabolic activation (2: presence, type)

                                    Concentrations of product (6 of these: 0, x, y, z,..., +CNTL);
                                    CytoTox % (3 different percentages from testing 1 portion of the original sample)
                                                4 MN counts conducted (on 4 different portions of original sample?)

EID (5 of these, Count1 - Count4 and Cytotox): with many TX Parm codes

Cytotox: RICC, RIC, RPD,  #cells


RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
11231TX


METACTMetabolic Activation+S9
2





METACTMetabolic Activation-S9







TRTDURTreatment DurationShort Term







TRTDURTreatment DurationLong Term (or 2 parm codes, # and unit)







PRDCONCConcentration of product0







PRDCONCUConcentration Unitug/ml







ProductProduct Name








Smoking Regime








Smoke Fraction













TXCS-10Cigarette Smoke Condensate, 10 ug/mL
ARMCDArm CodeCS-10



TXCS-10Cigarette Smoke Condensate, 10 ug/mL
SPECIESSpeciesSalmonella enterica 



TXCS-10Cigarette Smoke Condensate, 10 ug/mL
STRAINStrain/SubstrainSalmonella enterica enterica



TXCS-10Cigarette Smoke Condensate, 10 ug/mL
PRODUCTProductproduct A



TXCS-10Cigarette Smoke Condensate, 10 ug/mL
REGIMESmoking RegimeTraditional combustible 



TXCS-20Cigarette Smoke Condensate, 50 ug/mL
ARMCDArm CodeCS-20



TXCS-20Cigarette Smoke Condensate, 50 ug/mL
PRODUCTProductproduct A



...








TXLSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
TRTDOSDose Level100



TXLSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
TCNTRLControl TypePOSITIVE CONTROL



TXLSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
CNTLAGControl AgentSODIUM LAURYL SULPHATE



TXLSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
CNTLAGAMTControl Agent amount (levels)110




LSL-200sodium lauryl sulphate (SLS) positive control, 200 ug/mL
CNTLAGUNITControl Agent Unitug/mL
RowSTUDYIDDOMAINENID (Entity ID)RICCRCCRPDSum of cell ev.Cells with MNSMKFID (Smoke Fraction)

REPLCTID

(Replicate Number)

PLATEID (Plate ID)

COLID

(Column number)

ROWID (Row  number)
SETCD (Set Code, TX)RFSTDTCRFENDTCRFXSTDTCRFXENDTCRFCSTDTCRFCENDTCARMCD
1MA99999

GT






030001A111A
CS-102008-04-01T06:00

2008-04-28T14:00

2008-04-02T14:002008-04-02T14:042008-04-01T06:002008-04-01T06:003
2MA99999GT1


1-1030001A111B
CS-102008-04-01T06:002008-04-21T14:002008-04-02T20:002008-04-02T20:042008-04-01T06:002008-04-01T06:003



2






















3






















4



















  • Entity ID links to EI domain (usubjid)
  • TEST:  After ST exposure to increasing concentrations of test article in the presence of S9 mix


RowSTUDYIDDOMAINTXCDGTSEQ
GTTESTCDGTTESTGTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTCELLEV
(cells evaluated)
GTSPEC???GTMETHODGTDTCGTDYGTNOMDYGTELTMGTTPTREF
1ST487-12GT


RICC

ug/mL

ug/mL


25-05-2022



2ST487-12GT


RCC

ug/mL

ug/mL







3ST487-12GT


RPD

ug/mL

ug/mL







4ST487-12GT


CELLSSum of cells evaluated
ug/mL

ug/mL







5ST487-12GT


MNNUMCells with Micronuclei
ug/mL

ug/mL







6ST487-12GT


MNTIn vitro Micronucleus Assay
ug/mL

ug/mL







7ST487-12GT


MNTIn vitro Micronucleus Assay
ug/mL

ug/mL







8ST487-12GT


MNTIn vitro Micronucleus Assay
ug/mL

ug/mL







9ST487-12GT


MNTIn vitro Micronucleus Assay
ug/mL

ug/mL







  • No labels