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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


  • red font - indicates potential for CT code lists
  • green font - links to other domains
  • purple font - to be discussed

  • Assumption: The intent of this dataset is to provide a summary of trial (study) information. This is not subject-level data. 
  • Assumption: A Trial (study) can have more than one assay type
  • Assumption: ASSAYID value of ALL indicates that it applies to all assays in the study

Row

STUDYID

ASSAYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1123MNvitTS1
GLPTYPGood Laboratory Practice TypeFDA
2123MNvitTS2
GLPTYPGood Laboratory Practice TypeOECD
3123MNvitTS1
STSTDTCStudy Start Date2022-05-25
4123MNvitTS1
STITLEStudy Title

Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay


5123MNvitTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6123MNvitTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
7123MNvitTS1
SSPONSORSponsor OrganizationExample Sponsor Inc.
8123MNvitTS1
SPREFIDSponsor's Study Reference ID
NOT APPLICABLE
9123MNvitTS11TSTFNAMTest Facility NameExample Tox Lab Name
10123MNvitTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
11123MNvitTS11TFCNTRYTest Facility CountryUSA
12123MNvitTS11STDIRStudy DirectorDr. R. Smith
13123MNvitTS1
GLPFLGLP FlagY
14123MNvitTS1
ASTDAssay StandardOECD Test No. 487 
15123MNvitTS1
ASTDVAssay Standard Version2016-07-29
16123MNvitTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
17123MNvitTS1
SSSTYPStudy Sub TypeIn Vitro Micronucleus
18123MNvitTS1
SPECIESSpeciesHomo Sapiens
19123MNvitTS1
??Test System?TK6 Lymphoblastoid Suspension Cells
  • During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled;  For now, we just include good example values based on our experience
  • Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
  • Where is TK6 cell type?  is this test system (see below)
    • needs to be allowed to vary down to the well level / result level

A1:


A2:                                   

RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL

123MNvitTX

A1

(table 1, row 1, ST exposure with S9)



METACTMetabolic Activation  (should there be two parms? Presence, type)?+S9







METACTFLY/N presence of metabolic activation

123MNvitTXA1

TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)3

123MNvitTXA1

TRTDRTOLTreatment Duration Tolerance

123MNvitTXA1

TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)H

123MNvitTXA1

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

Tobacco ProdA

123MNvitTXA1

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Product

123MNvitTXA1

ITVCONCConcentration of intervention article0

123MNvitTXA1

ITVCONCUConcentration Unitug/ml

123MNvitTX

A2

(table 1, row 2)



METACTMetabolic Activation  (should there be two parms? Presence, type)?+S9

123MNvitTXA2

TRTDRTRGTreatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)3

123MNvitTXA2

TRTDRTOLTreatment Duration Tolerance

123MNvitTXA2

TRTDURUTreatment Duration Unit (this is for both TRTDURT, TRTDURTOL)H

123MNvitTXA2

INTRVNname of the intervention articleTobacco ProdA

123MNvitTXA2

ITVTYPEtype of intervention articleProduct

123MNvitTXA2

ITVCONCConcentration of i a 1250

123MNvitTXA2

ITVCONCUConcentration Unitug/ml
...






































A1:


A2:                                   


RowSTUDYIDASSAYIDDOMAINTXSETCDGTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)
GTORRESGTORRESUGTSTRESCGTSTRESNGTSTRESUGTDTC
1123MNvitGTA11RICCRelative Increase in Cell Count00%00%2022-05-25
2123MNvitGTA12RCCRelative Cell Count1540%00%2022-05-25
3123MNvitGTA13RPDRelative Population Doubling1540%00%2022-05-25
4123MNvitGTA14MNCELLSMicronucleated Cells220515Cells1515Cells2022-05-25
5123MNvitGTA15MNCELLSMicronucleated Cells247413Cells1313Cells2022-05-25
6123MNvitGTA16MNCELLSMicronucleated Cells275817Cells1717Cells2022-05-25
7123MNvitGTA17MNCELLSMicronucleated Cells266912Cells1212Cells2022-05-25
8123MNvitGTA18AVGRELAverage Relative MN Frequency
0.57%0.570.57%2022-05-25
9123MNvitGTA21RICCRelative Increase in Cell Count13415.7%15.715.7%2022-05-25
10123MNvitGTA22RCCRelative Cell Count13413.0%13.013.0%2022-05-25
11123MNvitGTA23RPDRelative Population Doubling1347.9%7.97.9%2022-05-25
12123MNvitGTA24MNCELLSMicronucleated Cells326620Cells2020Cells2022-05-25
13123MNvitGTA25MNCELLSMicronucleated Cells219017Cells1717Cells2022-05-25
14123MNvitGTA26MNCELLSMicronucleated Cells275813Cells1313Cells2022-05-25
15123MNvitGTA27MNCELLSMicronucleated Cells271421Cells2121Cells2022-05-25
16123MNvitGTA28AVGRELAverage Relative MN Frequency
0.66%0.660.66%2022-05-25
...













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