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titletx.xpt (trial sets)
  • 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

                         

RowSTUDYIDASSAYIDDOMAINSETCD
SET (what sponsor calls it)
TXSEQTXPARMCDTXPARMTXVAL

8325064AmesTX

P1 (plate 1)



METACTMetabolic Activation  (should there be two parms? Presence, type)?None

8325064AmesTXP1

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



TXP1

TRTDRTOLTreatment Duration Tolerance



TXP1

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



TXP1

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

DMSO TA1



TXP1

ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Vehicle Control



TXP1

ITVCONCConcentration of intervention article0



TXP1

ITVCONCUConcentration Unitug/ml



TXP1

STRAINStrain/SubstrainTA98



TXP1

REGIMESmoking Regime



TXP1

RUN

Assay run number

1




TXP1

PORTPort ID



TXP1

SMPLIDSample ID



TXP1

SMKFRCSmoke Fraction



TXP1

REPNUMReplicate Number











































TXP2

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



TXP2

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



TXP2

TRTDRTOLTreatment Duration Tolerance



TXP2

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



TXP2

INTRVNname of the intervention articleDMSO TA1



TXP2

ITVTYPEtype of intervention articleProduct



TXP2

ITVCONCConcentration of i a 1250



TXP2

ITVCONCUConcentration Unitug/ml



TXP2

STRAINStrain/SubstrainWP2 uvrA pKM10 1



TXP2

REGIMESmoking Regime



TXP2

RUN

Assay run number

1




TXP2

PORTPort ID



TXP2

SMPLIDSample ID



TXP2

SMKFRCSmoke Fraction



TXP2

REPNUMReplicate Number

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