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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

  • Assumption: Study can have more than one assay type
  • Assumption: ASSAYID value of ALL means it applies to all assays in the study

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123

ALL

TS1
GLPTYPGood Laboratory Practice TypeFDA
11123ALLTS1
STSTDTCStudy Start Date2007-12-30
13123ALLTS1
STITLEStudy TitleExample of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14123ALLTS1
SNDIGVERSEND Implementation Guide VersionTobacco IMPLEMENTATION GUIDE VERSION 1.0
15123

ALL

TS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-03-26
17123ALLTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
18123ALLTS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
19123ALLTS11TSTFNAMTest Facility NameExample Tox Lab Name
20123

ALL

TS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
21123ALLTS11TFCNTRYTest Facility CountryUSA
24123ALLTS11STDIRStudy DirectorDr. R. Smith
25123
TS1
TRTInvestigational Therapy or TreatmentDrug A
26123
TS12TRTVTreatment VehicleSaline
27123
TS12TRTVDESCTreatment Vehicle Structured Description100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}
28123ALLTS1
GLPFLGLP FlagY
29123MNTTS1
ASTDAssay StandardOECD Test No. 487 
30123MNTTS1
ASTDVAssay Standard Version2016-07-29
31123MNTTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
32123MNTTS1
SSSTYPStudy Sub TypeIn Vitro Micronucleus
33123MNTTS1
SPECIESSpeciesHomo Sapiens
34123MNTTS1
??Test System?TK6 Lymphoblastoid Suspension Cells
35123NRUTS1
ASTDAssay StandardNIH Publication No. 07-4519
36123NRUTS1
ASTDVAssay Standard Version2006-11
37123NRUTS1
SSTYPStudy Type

38123NRUTS1
SSSTYPStudy Sub TypeIn Vitro Neutral Red Uptake
39123NRUTS1
SPECIESSpeciesHomo Sapiens

40

123NRUTS1
??Test System??Normal Human Keratinocyte

Treatment Duration will be controlled?  During CT definition/revies will need to decide appropriate Treatment duration values; If not, what are best example values to show?

RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123MNTTXA1

METACTMetabolic Activation+S9
2123MNTTXA1

TRTDURTreatment DurationShort Term
3123MNTTXA1

PRDCONCConcentration of product0
4123MNTTXA1

PRDCONCUConcentration Unitug/ml
5123MNTTXA1

ProductProduct Name
6123MNTTXA1


Smoking Regime
7123MNTTXA1


Smoke Fraction

123MNTTXA2

METACTMetabolic Activation+S9

123MNTTXA2

TRTDURTreatment DurationShort Term

123MNTTXA2

PRDCONCConcentration of product1250

123MNTTXA2

PRDCONCUConcentration Unitug/ml

123MNTTXA2

ProductProduct Name

123MNTTXA2


Smoking Regime

123MNTTXA2


Smoke Fraction




















8123MNTTX

B



METACTMetabolic Activation-S9
9123MNTTX

B



TRTDURTreatment DurationShort Term
10123MNTTXB

TRTDURTreatment DurationLong Term (or 2 parm codes, # and unit)
11123MNTTX

B



PRDCONCConcentration of product0
12123MNTTX

B



PRDCONCUConcentration Unitug/ml
13123MNTTXB

ProductProduct Name
14123MNTTXB


Smoking Regime
15123MNTTXB


Smoke Fraction










8123MNTTX

C



METACTMetabolic Activation-S9
9123MNTTX

C



TRTDURTreatment DurationLong Term
10123MNTTXC

TRTDURTreatment DurationLong Term (or 2 parm codes, # and unit)
11123MNTTX

C



PRDCONCConcentration of product0
12123MNTTX

C



PRDCONCUConcentration Unitug/ml
13123MNTTX

C



ProductProduct Name
14123MNTTXC


Smoking Regime
15123MNTTX

C




Smoke Fraction

BLEO & CPA - positive controls?


RowSTUDYIDASSAYIDDOMAINTXCDGTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)
GTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTDTCGTNOMDYGTELTMGTTPTREF
1123MNTGTA21RICC
13415.7%15.715.7%2022-05-25


2123MNTGTA22RCC
13413.0%13.013.0%2022-05-25


3123MNTGTA23RPD
1347.9%7.97.9%2022-05-25


4123MNTGTA24MNCELLSMicronucleated Cells326620Cells2020Cells2022-05-25


5123MNTGTA25MNCELLSMicronucleated Cells219017Cells1717Cells2022-05-25


6123MNTGTA26MNCELLSMicronucleated Cells275813Cells1313Cells2022-05-25


7123MNTGTA27MNCELLSMicronucleated Cells271421Cells2121Cells2022-05-25


8123MNTGTA28AVGRELAverage Relative MN Frequency
0.66%0.660.66%2022-05-25


9123MNTGTA11RICC
1540%00%2022-05-25


10123MNTGTA12RCC
1540%00%2022-05-25


11123MNTGTA13RPD
1540%00%2022-05-25


12123MNTGTA14MNCELLSMicronucleated Cells326615Cells1515Cells2022-05-25


13123MNTGTA15MNCELLSMicronucleated Cells219013Cells1313Cells2022-05-25


14123MNTGTA16MNCELLSMicronucleated Cells275817Cells1717Cells2022-05-25


15123MNTGTA17MNCELLSMicronucleated Cells271412Cells1212Cells2022-05-25


16123MNTGTA18AVGRELAverage Relative MN Frequency
0.57%0.570.57%2022-05-25










































































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??

(also see Gentox notes on how to approach modeling, to apply that here?)

(Do we need this? a single element (treatment)?)

RowSTUDYIDASSAYIDDOMAINETCDELEMENT

(Do we need this? one arm for each trial set?)

RowSTUDYIDASSAYIDDOMAINARMCDARMTAETORDETCDELEMENT
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
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