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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: 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
  • Assumption: SPDEVID and DUREFID should only 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).  While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
    • 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
  • Assumption:  SPDEVID (sponsor defined device identifier), and Test System  should be added at the trial set level (tx.xpt).  While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
    • 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)
  • Assumption: SPDEVID and DUREFID should only 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).  While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
    • 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)


A1:


A2:                                   

RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
1123MNvitTX

A1

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

ST+S9C01TESTSYSTest systemTK6 Lymphoblastoid Suspension Cells
2123MNvitTX

A1

ST+S9C02METACTMetabolic Activation  (this is the type of activation used)+S9
3123MNvitTXA1ST+S9C03METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)Y
4123MNvitTX

A1

ST+S9C04TRTDMINTreatment Duration Minimum3
5123MNvitTXA1ST+S9C05TRTDTRGTreatment Duration Target3.5
6123MNvitTXA1ST+S9C06TRTDMAXTreatment Duration Maximum4
7123MNvitTX

A1

ST+S9C07TRTDUTreatment Duration UnitHOURS
8123MNvitTXA1ST+S9C08RCVDMINRecovery Duration Minimum23.5
9123MNvitTXA1ST+S9C09RCVDTRGRecovery Duration Target24
10123MNvitTX

A1

ST+S9C010RCVDMAXRecovery Duration Maximum24.5
11123MNvitTXA1ST+S9C011RCVDURecovery Duration UnitHOURS
12123MNvitTXA1ST+S9C012INCBTMPIncubation Temperature37
13123MNvitTX

A1

ST+S9C013INCBTMPUIncubation Temperature UnitC
14123MNvitTXA1ST+S9C014HUMIDAtmospheric Relative Humidity  Percent50
15123MNvitTX

A1

ST+S9C015ATMCO2Atmospheric CO2 Percent5
16123MNvitTXA1ST+S9C016

SPTOBID

Sponsor defined tobacco identifier

CIG01a
17123MNvitTXA1ST+S9C017EXPTYP

Exposure Type 

Submerged
18123MNvitTXA1ST+S9C018SAMTYP 

Sample Type

Total Particulate Matter in DMSO
19123MNvitTXA1ST+S9C019INTRVN

Name of the Intervention Article

Tobacco ProdA
20123MNvitTXA1ST+S9C020ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Negative Control
21123MNvitTXA1ST+S9C021ITVCONCConcentration of intervention article0
22123MNvitTXA1ST+S9C022ITVCONCUConcentration Unitug/ml
23123MNvitTXA1ST+S9C023

SPDEVID

Sponsor defined device identifierPUFFMASTER3K
24123MNvitTXA1ST+S9C024

DUREFID 

Smoke RegimenMedium Intensity Regimen
25123MNvitTX

A2

(table 1, row 2, ST exposure with S9 at concentration 1250)

ST+S9-12501TESTSYSTest systemTK6 Lymphoblastoid Suspension Cells
26123MNvitTX

A2

ST+S9-12502METACTMetabolic Activation  (this is the type of activation used)+S9
27123MNvitTXA2ST+S9-12503METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)Y
28123MNvitTXA2ST+S9-12504TRTDMINTreatment Duration Minimum3
29123MNvitTXA2ST+S9-12505TRTDTRGTreatment Duration Target3.5
30123MNvitTXA2ST+S9-12506TRTDMAXTreatment Duration Maximum4
31123MNvitTXA2ST+S9-12507TRTDUTreatment Duration UnitHOURS
32123MNvitTXA2ST+S9-12508RCVDMINRecovery Duration Minimum23.5
33123MNvitTXA2ST+S9-12509RCVDTRGRecovery Duration Target24
34123MNvitTXA2ST+S9-125010RCVDMAXRecovery Duration Maximum24.5
35123MNvitTXA2ST+S9-125011RCVDURecovery Duration UnitHOURS
36123MNvitTXA2ST+S9-125012INCBTMPIncubation Temperature37
37123MNvitTXA2ST+S9-125013INCBTMPUIncubation Temperature UnitC
38123MNvitTXA2ST+S9-125014HUMIDAtmospheric Relative Humidity  Percent50
39123MNvitTXA2ST+S9-125015ATMCO2Atmospheric CO2 Percent5
40123MNvitTXA2ST+S9-125016SPTOBID

Sponsor defined tobacco identifier

CIG01a
41123MNvitTXA2ST+S9-125017EXPTYP

Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical)

Submerged
42123MNvitTXA2ST+S9-125018SAMTYP 

Sample Type

(e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical)

Total Particulate Matter in DMSO
43123MNvitTXA2ST+S9-125019INTRVN

Name of the Intervention Article

Tobacco ProdA
44123MNvitTXA2ST+S9-125020ITVTYPE

type of intervention article

choices of values:  product; negative control; positive control

Product
45123MNvitTXA2ST+S9-125021ITVCONCConcentration of intervention article1250
46123MNvitTXA2ST+S9-125022ITVCONCUConcentration Unitug/ml
47123MNvitTXA2ST+S9-125023SPDEVIDSponsor defined device identifierPUFFMASTER2023
48123MNvitTXA2ST+S9-125024DUREFIDSmoke RegimenHigh Intensity Regimen
...








(This is a copy from the SDTM Example. Cigarette Design Parameters)

Rows 1-4:Show the records for the product identifiers for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT IDENTIFIERS.
Rows 5-10:Show the records for the product descriptors for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT DESCRIPTOR.


to.xpt

Row

STUDYID

DOMAIN

SPTOBID

TOSEQ

TOTESTCD

TOTEST

TOCAT

TOORRES

TOORRESU

TOSTRESC

TOSTRESN

TOSTRESU

1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERCigarette
Cigarette

2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERFiltered, Combusted
Filtered, Combusted

3TOB07TOCIG01a3MANUFManufacturerPRODUCT IDENTIFIERJoes Cigs USA
Joes Cigs USA

4TOB07TOCIG01a4TRADENAMTrade NamePRODUCT IDENTIFIERTreetop Menthol King Size
Treetop Menthol King Size

5TOB07TOCIG01a5PACKTYPPackage TypePRODUCT DESCRIPTORHARD PACK
HARD PACK

6TOB07TOCIG01a6PRDQUANProduct QuantityPRODUCT DESCRIPTOR20CIGARETTE2020CIGARETTE
7TOB07TOCIG01a7LENGTHLengthPRODUCT DESCRIPTOR86.0mm86.086.0mm
8TOB07TOCIG01a8CIRCUMFCircumferencePRODUCT DESCRIPTOR26.0mm26.026.0mm
9TOB07TOCIG01a9VENTLTNVentilationPRODUCT DESCRIPTOR10.0%10.010.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorPRODUCT DESCRIPTORMENTHOL
MENTHOL

di.xpt (copied v1.0 of medical devices IG)

  • This example is a copy of Example 1 from di.xpt in SDTMIG-MD v1.0 but with values for SPDEVID and DIVAL revised slightly. 
  • Should I remove the FDA UDI (row 5) unless CTP has or plans to establish UDI values?

Example 1
This shows records for two three devices where the sponsor felt that the type, manufacturer, model number, and serial number were necessary for unique identification. In addition, there was a post-marketing UDI identifier available for the first device.

  • Rows 1-5 show the records for a device given a SPDEVID of PUFFMASTER3K
  • Rows 5-8 show the records for a device given a SPDEVID of PUFFMASTER2023
  • Rows 9-12 show


Row

STUDYID

DOMAIN

SPDEVID

DISEQ

DIPARMCD

DIPARM

DIVAL

1

123

DI

PUFFMASTER3K

1

DEVTYPE

Device Type

ENDS

2

123

DI

PUFFMASTER3K

2

MANUF

Manufacturer

Acme Machines

3

123

DI

PUFFMASTER3K

3

MODEL

Model Number

45-JFI

4

123

DI

PUFFMASTER3K

4

SERIAL

Serial Number

456789132-AXQ

5

123

DI

PUFFMASTER3K

5

FDAUDI

FDA Unique Device Identifier

456789123xyz

6

123

DI

PUFFMASTER2023

1

DEVTYPE

Device Type

SmokeMachine

7

123

DI

PUFFMASTER2023

2

MANUF

Manufacturer

Acme Machines

8

123

DI

PUFFMASTER2023

3

MODEL

Model Number

62-PLC

9

123

DI

PUFFMASTER2023

4

SERIAL

Serial Number

215964564-NFS

10

123

DI

UsualCTCigarette

1

DEVTYPE

Device Type

Combustible Tobacco Cigarette

11

123

DI

UsualCTCigarette

2

MANUF

Manufacturer

Philip Morris International

12

123

DI

UsualCTCigarette

3

MODEL

Model Number

Marlboro Red

13

123

DI

UsualCTCigarette

4

SERIAL

Serial Number

123456789

 We use DU for smoking regimen. Note that a separate DI dataset will be needed to show identifying parameters of the "PUFFMASTER3K" smoking machine

  • 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"

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



RowSTUDYIDASSAYIDDOMAINSETCD (from TX)EUIDOBUID
1123MNvitEIA11-8-3
2123MNvitEIA12-8-3
3123MNvitEIA12-9-3
4123MNvitEIA23-7-1
5123MNvitEIA22-7-1



A1:


A2:                                   


  • Different runs would be expected to have different ENID and GTDTC values. In ei.xpt, these are distinguished by different RUNID values.
RowSTUDYIDASSAYIDDOMAINEUID

OBUID

??

GTSEQGTTESTCDGTTESTGTCELLEV
(cells evaluated)
GTORRESGTORRESU

GTCOLSRT

???

GTSTRESCGTSTRESNGTSTRESUGTDTC
1123MNvitGT1-8-3
1RICCRelative Increase in Cell Count1540%
00%2022-05-25
2123MNvitGT1-8-3
2RCCRelative Cell Count1540%
00%2022-05-25
3123MNvitGT1-8-3
3RPDRelative Population Doubling1540%
00%2022-05-25
4123MNvitGT1-8-3
4MNCELLSMicronucleated Cells220515Cells
1515Cells2022-05-25
5123MNvitGT1-8-3
5MNCELLSMicronucleated Cells247413Cells
1313Cells2022-05-25
6123MNvitGT1-8-3
6MNCELLSMicronucleated Cells275817Cells
1717Cells2022-05-25
7123MNvitGT1-8-3
7MNCELLSMicronucleated Cells266912Cells
1212Cells2022-05-25
8123MNvitGT1-8-3
8AVGRELAverage Relative MN Frequency
0.57%
0.570.57%2022-05-25
9123MNvitGT2-8-3
1RICCRelative Increase in Cell Count13415.7%
15.715.7%2022-05-25
10123MNvitGT2-8-3
2RCCRelative Cell Count13413.0%
13.013.0%2022-05-25
11123MNvitGT2-8-3
3RPDRelative Population Doubling1347.9%
7.97.9%2022-05-25
12123MNvitGT2-8-3
4MNCELLSMicronucleated Cells326620Cells
2020Cells2022-05-25
13123MNvitGT2-8-3
5MNCELLSMicronucleated Cells219017Cells
1717Cells2022-05-25
14123MNvitGT2-8-3
6MNCELLSMicronucleated Cells275813Cells
1313Cells2022-05-25
15123MNvitGT2-8-3
7MNCELLSMicronucleated Cells271421Cells
2121Cells2022-05-25
16123MNvitGT2-8-3
8AVGRELAverage Relative MN Frequency
0.66%
0.660.66%2022-05-25
...















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