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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
  • This example currently shows SPDEVID and DUREFID in BOTH the TS domain and the TX domain, but we should discuss if this should only ever be in TX (with the same value for all sets if there is only one device used)
  • Assumption:  SPDEVID (sponsor defined device identifier) should be added at the trial set level (tx.xpt) - we can discuss if this should be in TS when there is only one device for a study
    • This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)

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
20123MNvitTS1
SPDEVIDSponsor defined device identifierPUFFMASTER3K
21123MNvitTS1
DUREFIDSmoke RegimenMedium Intensity Regimen
  • 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

123MNvitTSA1
SPDEVIDSponsor defined device identifierPUFFMASTER3K

123MNvitTSA1
DUREFIDSmoke RegimenMedium Intensity Regimen

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

123MNvitTSA2
SPDEVIDSponsor defined device identifierPUFFMASTER2023

123MNvitTSA2
DUREFIDSmoke RegimenHigh Intensity Regimen
...






































 We use DU for smoking regimen. Note that a separate DI dataset will be needed to show identifying parameters of the "PUFFMASTER3K" smoking machine, but is currently not shown for brevity.

  • Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).
  • Smoking regimen is represented in --REFID (we made up a value of "Medium Intensity Regimen"; we can update with something realistic)
  • The smoking regimen is carried out by the smoking machine/device shown in SPDEVID, Sponsor defined device identifier, "PUFFMASTER3K"
  • Do we need both SPDEVID AND DUREFID?

du.xpt

Row

STUDYID

DOMAIN

SPDEVID

DUSEQ

DUREFID

DUGRPID

DUTESTCD

DUTEST

DUORRES

DUORRESU

DUSTRESC

DUSTRESN

DUSTRESU

1123DUPUFFMASTER3K1Medium Intensity Regimen
PUFFPROFPuff ProfileSQUARE
SQUARE

2123DUPUFFMASTER3K2Medium Intensity Regimen

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3123DUPUFFMASTER3K3Medium Intensity Regimen

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4123DUPUFFMASTER3K4Medium Intensity Regimen

PUFFBLCK

Puff Block

25

%

25

25

%

5123DUPUFFMASTER3K5Medium Intensity Regimen
NUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

6123DUPUFFMASTER3K6Medium Intensity Regimen
PUFFVOLPuff Volume

10

mL

10

10

mL

7123DUPUFFMASTER3K7Medium Intensity Regimen
PUFFRNGPuff Range

100-200


100-200



8123DUPUFFMASTER3K8Medium Intensity Regimen1PUFFPAUSPuff Pause

60

s

60

60

s

9123DUPUFFMASTER3K9Medium Intensity Regimen1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

10123DUPUFFMASTER20231

Canadian Intense Regime


PUFFPROFPuff ProfileSQUARE
SQUARE

11123DUPUFFMASTER20232Canadian Intense Regime

PUFFDUR

Puff Duration

2.00

sec

2.00

2.00

sec

12123DUPUFFMASTER20233Canadian Intense Regime

PUFFINT

Puff Interval

4

PUFF/min

4

4

PUFF/min

13123DUPUFFMASTER20234

Canadian Intense Regime


PUFFBLCK

Puff Block

0

%

0

0

%

14123DUPUFFMASTER20235Canadian Intense Regime
NUMPUFFTotal Number of Puffs

200

PUFF

200

200

PUFF

15123DUPUFFMASTER20236Canadian Intense Regime
PUFFVOLPuff Volume

10

mL

10

10

mL

16123DUPUFFMASTER20237

Canadian Intense Regime


PUFFRNGPuff Range

100-200


100-200



17123DUPUFFMASTER20238Canadian Intense Regime1PUFFPAUSPuff Pause

60

s

60

60

s

18123DUPUFFMASTER20239Canadian Intense Regime1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

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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