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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
RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123MNTTXA

METACTMetabolic Activation+S9


MNT
A

TRTDURTreatment DurationShort Term


MNT
A

PRDCONCConcentration of product1250




A

PRDCONCUConcentration Unitug/ml




A

ProductProduct Name




A


Smoking Regime




A


Smoke Fraction

















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
RowSTUDYIDASSAYIDDOMAINTXCDGTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)
GTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTDTCGTNOMDYGTELTMGTTPTREF
1123MNTGTA1RICC
13415.7%15.715.7%2022-05-25


2123MNTGTA2RCC
13413.0%13.013.0%2022-05-25


3123MNTGTA3RPD
1347.9%7.97.9%2022-05-25


4123MNTGTA4MNCELLSMicronucleated Cells326620Cells2020Cells2022-05-25


5123MNTGTA5MNCELLSMicronucleated Cells219017Cells1717Cells2022-05-25


6123MNTGTA6MNCELLSMicronucleated Cells725813Cells1313Cells2022-05-25


7123MNTGTA7AVGRELAverage Relative MN Frequency
0.66%0.660.66%2022-05-25


8123NRUGT













9

GT














concept map?

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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