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This is an example showing example shows a sample report table, trial design, and results data of Study #123 dataset for study 123 for the determination of the in vitro genotoxicity potential of 10? tobacco products in using the in vitro Micronucleus Assaymicronucleus assay.

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title	Sample Report Table for Study 123, Raw data (for reference only, will be deleted?)

ASSAYID

Dataset wrap

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title	ts.xpt (trial summary, study level parameters)

Rowcaps

Rows 1-2:	Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records, since both GLP types apply for this example study.
Row 3:	Shows that this study was conducted as a GLP study.
Rows 4-5:	Show the study start date and study title.
Rows 6-7:	Show the version of SEND Implementation Guide and version of Controlled Terminology used in this study.
Row 8:	Shows the applicant's organization.
Row 9:	Shows that the applicant's study reference ID is not applicable.
Rows 10-13:	Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = 1). The study director is associated with the test facility.
Rows 14-16:	Show that TSGRPID (TSGRPID=2) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).
Row 17:	Shows the study type for this study.
Row 18:	Shows that this study includes a Mammalian Cell Micronucleus Assay.
Rows 19-20:	Show that the species is human and the cell line is TK6 lymphoblastoid in this study.

Dataset2

Row	STUDYID

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

	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123

MNvit

	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123

MNvit

TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123

MNvit

TS

1

GLPFL

STSTDTCStudy Start Date2022-

GLP Flag	Y
4	123	TS	1		STSTDTC	Study Start Date	2022-05-25

4


5	123

MNvit

TS

1

STITLE

Study Title

Determination of the in vitro genotoxicity potential

of 10 tobacco products in the in vitro Micronucleus Assay

using the in vitro Neutral Red Uptake assay
6	123

5123MNvit

TS

1

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0

6


7	123

MNvit

TS

1

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30

7


8	123

MNvit

TS

1

SSPONSOR

APPLCNT

Sponsor Organization

Applicant

Example

Sponsor

Applicant, Inc.

8


9	123

MNvit

TS

1

SPREFIDSponsor's Study

APREFID

Study Reference ID

NOT APPLICABLE

9

10

123

MNvit

TS

1

TSTFNAM

Test Facility Name

Example

Tox

Test Lab Name

10


11	123

MNvit

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

11


12	123

MNvit

TS

1

TFCNTRY

Test Facility Country

USA

12


13	123

MNvit

TS

1

STDIR

Study Director

Dr. R. Smith

13


14	123

MNvit

TS

1

2

GLPFLGLP FlagY14

TSTGDNAM	Testing Guideline Name	GUIDELINE FOR THE TESTING OF CHEMICALS No. 487
15	123

MNvit

TS

1

2

ASTDAssay Standard

TSTGDORG

Testing Guideline Organization

OECD

Test No. 487

15


16	123

MNvit

TS

1

2

ASTDV

TSTGDVER

Assay Standard

Testing Guideline Version

2016

29-

07

July-

29

2016

16


17	123

MNvit

TS

1

SSTYP

Study Type

GENOTOXICITY IN VITRO

17


18	123

MNvit

TS

1

SSSTYPStudy Sub TypeIn Vitro Micronucleus

	GNTXAID	Genetic Toxicology Assay Identifier	MNvit
19	123

18123MNvit

TS

1

SPECIES

Species

HUMAN

Homo Sapiens

20

expand

123

title	tx.xpt (trial sets)

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: Image Removed

A2: Image Removed

RowSTUDYIDASSAYIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL1123MNvitTX

A1

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

ST+S9C01TESTSYSTest systemTK6 Lymphoblastoid Suspension Cells2123MNvitTX

A1

ST+S9C02METACTMetabolic Activation (this is the type of activation used)+S93123MNvitTXA1ST+S9C03METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)Y4123MNvitTX

A1

ST+S9C04TRTDMINTreatment Duration Minimum35123MNvitTXA1ST+S9C05TRTDTRGTreatment Duration Target3.56123MNvitTXA1ST+S9C06TRTDMAXTreatment Duration Maximum47123MNvitTX

A1

ST+S9C07TRTDUTreatment Duration UnitHOURS8123MNvitTXA1ST+S9C08RCVDMINRecovery Duration Minimum23.59123MNvitTXA1ST+S9C09RCVDTRGRecovery Duration Target2410123MNvitTX

A1

ST+S9C010RCVDMAXRecovery Duration Maximum24.511123MNvitTXA1ST+S9C011RCVDURecovery Duration UnitHOURS12123MNvitTXA1ST+S9C012INCBTMPIncubation Temperature3713123MNvitTX

A1

ST+S9C013INCBTMPUIncubation Temperature UnitC14123MNvitTXA1ST+S9C014HUMIDAtmospheric Relative Humidity Percent5015123MNvitTX

A1

ST+S9C015ATMCO2Atmospheric CO2 Percent516123MNvitTXA1ST+S9C016

SPTOBID

Sponsor defined tobacco identifier

CIG01a17123MNvitTXA1ST+S9C017EXPTYP

Exposure Type

Submerged18123MNvitTXA1ST+S9C018SAMTYP

Sample Type

Total Particulate Matter in DMSO19123MNvitTXA1ST+S9C019INTRVN

Name of the Intervention Article

Tobacco ProdA20123MNvitTXA1ST+S9C020ITVTYPE

type of intervention article

choices of values: product; negative control; positive control

Negative Control21123MNvitTXA1ST+S9C021ITVCONCConcentration of intervention article022123MNvitTXA1ST+S9C022ITVCONCUConcentration Unitug/ml23123MNvitTXA1ST+S9C023

SPDEVID

Sponsor defined device identifierPUFFMASTER3K24123MNvitTXA1ST+S9C024

DUREFID

Smoke RegimenMedium Intensity Regimen25123MNvitTX

A2

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

ST+S9-12501TESTSYSTest systemTK6 Lymphoblastoid Suspension Cells26123MNvitTX

A2

ST+S9-12502METACTMetabolic Activation (this is the type of activation used)+S927123MNvitTXA2ST+S9-12503METACTFLY/N presence of metabolic activation (this indicates that metabolic activation was used)Y28123MNvitTXA2ST+S9-12504TRTDMINTreatment Duration Minimum329123MNvitTXA2ST+S9-12505TRTDTRGTreatment Duration Target3.530123MNvitTXA2ST+S9-12506TRTDMAXTreatment Duration Maximum431123MNvitTXA2ST+S9-12507TRTDUTreatment Duration UnitHOURS32123MNvitTXA2ST+S9-12508RCVDMINRecovery Duration Minimum23.533123MNvitTXA2ST+S9-12509RCVDTRGRecovery Duration Target2434123MNvitTXA2ST+S9-125010RCVDMAXRecovery Duration Maximum24.535123MNvitTXA2ST+S9-125011RCVDURecovery Duration UnitHOURS36123MNvitTXA2ST+S9-125012INCBTMPIncubation Temperature3737123MNvitTXA2ST+S9-125013INCBTMPUIncubation Temperature UnitC38123MNvitTXA2ST+S9-125014HUMIDAtmospheric Relative Humidity Percent5039123MNvitTXA2ST+S9-125015ATMCO2Atmospheric CO2 Percent540123MNvitTXA2ST+S9-125016SPTOBID

Sponsor defined tobacco identifier

CIG01a41123MNvitTXA2ST+S9-125017EXPTYP

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

Submerged42123MNvitTXA2ST+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 DMSO43123MNvitTXA2ST+S9-125019INTRVN

Name of the Intervention Article

Tobacco ProdA44123MNvitTXA2ST+S9-125020ITVTYPE

type of intervention article

choices of values: product; negative control; positive control

Product45123MNvitTXA2ST+S9-125021ITVCONCConcentration of intervention article125046123MNvitTXA2ST+S9-125022ITVCONCUConcentration Unitug/ml47123MNvitTXA2ST+S9-125023SPDEVIDSponsor defined device identifierPUFFMASTER202348123MNvitTXA2ST+S9-125024DUREFIDSmoke RegimenHigh Intensity Regimen...

TS

1

CELLLN

Cell Line

TK6 LYMPHOBLASTOID

This example Trial Sets dataset shows information about the test conditions for set A1 and A2 in this example study. Sets A1 and A2 can be seen in the first and second rows respectively of the sample report Table 1 (above). For brevity, the TX dataset and the findings (GT) dataset do not show information for any other sets. Fully formed datasets for this example study would include information about the test conditions and findings for all sets.

Dataset wrap

Name	tx

Rowcaps

Rows 1-23:

Show trial set parameters and values that comprise the test conditions for trial set A1. Set A1 is the data for the negative control (concentration 0) with short-term exposure and metabolic activation S9. The applicant has chosen to given a long name (SET) equal to "ST+S9_C0".

Set A1 is associated with the first row in the sample report table for study 123.

Rows 24-46:

Show trial set parameters and values that comprise the test conditions for trial set A2. Set A2 is the data for the short-term exposure with metabolic activation S9 at a concentration of 1250 ug/ml. The applicant has chosen to give the set a long name (SET) equal to "ST+S9_C1250".

Set A2 is associated with the second row in the sample report table for study 123.

Dataset2

Row	STUDYID	DOMAIN	SETCD	SET	TXSEQ	TXPARMCD	TXPARM	TXVAL
1	123	TX	A1	ST+S9_C0	1	MTACTIND	Metabolic Activating Agent Name	+S9
2	123	TX	A1	ST+S9_C0	2	METACTFL	Presence of Metabolic Activation Flag	Y
3	123	TX	A1	ST+S9_C0	3	IVTDMIN	In vitro Treatment Duration Minimum	3
4	123	TX	A1	ST+S9_C0	4	IVTDTRG	In vitro Treatment Duration Target	3.5
5	123	TX	A1	ST+S9_C0	5	IVTDMAX	In vitro Treatment Duration Maximum	4
6	123	TX	A1	ST+S9_C0	6	IVTDU	In vitro Treatment Duration Unit	HOURS
7	123	TX	A1	ST+S9_C0	7	RCVDMIN	Recovery Duration Minimum	23.5
8	123	TX	A1	ST+S9_C0	8	RCVDTRG	Recovery Duration Target	24
9	123	TX	A1	ST+S9_C0	9	RCVDMAX	Recovery Duration Maximum	24.5
10	123	TX	A1	ST+S9_C0	10	RCVDU	Recovery Duration Unit	HOURS
11	123	TX	A1	ST+S9_C0	11	INCBTMP	Incubation Temperature	37
12	123	TX	A1	ST+S9_C0	12	INCBTMPU	Incubation Temperature Unit	C
13	123	TX	A1	ST+S9_C0	13	ATMRHP	Atmospheric Relative Humidity Percent	50
14	123	TX	A1	ST+S9_C0	14	ATMCO2P	Atmospheric CO2 Percent	5
15	123	TX	A1	ST+S9_C0	15	SPTOBID	Applicant-defined tobacco identifier	CIG01a
16	123	TX	A1	ST+S9_C0	16	EXPTYP	Exposure Type	Submerged
17	123	TX	A1	ST+S9_C0	17	SAMTYP	Sample Type	Total Particulate Matter in DMSO
18	123	TX	A1	ST+S9_CO	18	ITVNAM	Intervention Article Name	Tobacco ProdA
19	123	TX	A1	ST+S9_C0	19	ITVTYPE	Intervention Article Type	Negative Control
20	123	TX	A1	ST+S9_C0	20	ITVCONC	Intervention Article Concentration	0
21	123	TX	A1	ST+S9_C0	21	ITVCONCU	Intervention Article Concentration Unit	ug/ml
22	123	TX	A1	ST+S9_C0	22	SPDEVID	Applicant-defined device identifier	PUFFMASTER3K
23	123	TX	A1	ST+S9_C0	23	SMKRGM	Smoking Regimen	MEDIUM INTENSITY REGIMEN
24	123	TX	A2	ST+S9_C1250	24	MTACTIND	Metabolic Activating Agent Name	+S9
25	123	TX	A2	ST+S9_C1250	25	METACTFL	Presence of Metabolic Activation Flag	Y
26	123	TX	A2	ST+S9_C1250	26	IVTDMIN	In vitro Treatment Duration Minimum	3
27	123	TX	A2	ST+S9_C1250	27	IVTDTRG	In vitro Treatment Duration Target	3.5
28	123	TX	A2	ST+S9_C1250	28	IVTDMAX	In vitro Treatment Duration Maximum	4
29	123	TX	A2	ST+S9_C1250	29	IVTDU	In vitro Treatment Duration Unit	HOURS
30	123	TX	A2	ST+S9_C1250	30	RCVDMIN	Recovery Duration Minimum	23.5
31	123	TX	A2	ST+S9_C1250	31	RCVDTRG	Recovery Duration Target	24
32	123	TX	A2	ST+S9_C1250	32	RCVDMAX	Recovery Duration Maximum	24.5
33	123	TX	A2	ST+S9_C1250	33	RCVDU	Recovery Duration Unit	HOURS
34	123	TX	A2	ST+S9_C1250	34	INCBTMP	Incubation Temperature	37
35	123	TX	A2	ST+S9_C1250	35	INCBTMPU	Incubation Temperature Unit	C
36	123	TX	A2	ST+S9_C1250	36	ATMRHP	Atmospheric Relative Humidity Percent	50
37	123	TX	A2	ST+S9_C1250	37	ATMCO2P	Atmospheric CO2 Percent	5
38	123	TX	A2	ST+S9_C1250	38	SPTOBID	Applicant-defined tobacco identifier	CIG01a
39	123	TX	A2	ST+S9_C1250	39	EXPTYP	Exposure Type	Submerged
40	123	TX	A2	ST+S9_C1250	40	SAMTYP	Sample Type	Total Particulate Matter in DMSO
41	123	TX	A2	ST+S9_C1250	41	ITVNAM	Intervention Article Name	Tobacco ProdA
42	123	TX	A2	ST+S9_C1250	42	ITVTYPE	Intervention Article Type	Product
43	123	TX	A2	ST+S9_C1250	43	ITVCONC	Intervention Article Concentration	1250
44	123	TX	A2	ST+S9_C1250	44	ITVCONCU	Intervention Article Concentration Unit	ug/ml
45	123	TX	A2	ST+S9_C1250	45	SPDEVID	Applicant-defined Device Identifier	PUFFMASTER2023
46	123	TX	A2	ST+S9_C1250	46	SMKRGM	Smoking Regimen	HIGH INTENSITY REGIMEN

Dataset wrap

Name	relref

Rowcaps

Row 1:	Shows the value of REFID=C0. This REFID refers to the trial set with a SETCD of "A1", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.
Rows 2-5:	Show the values of 4 observational units (C0_Count1 through C0_Count4) that are within the parent experimental unit, REFID=C0. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.
Row 6:	Shows the value of REFID=C1250. This REFID refers to the trial set with a SETCD of "A2", as defined in the TX dataset. LEVEL=1 and LVLDESC="EXPERIMENTAL UNIT/TRIAL SET" indicates this identifier is referring to both the experimental unit and the unit to which the treatment is applied, and to the entire trial set.
Rows 7-10:	Show the values of 4 observational units (C1250_Count1 through C1250_Count4) that are within the parent experimental unit, REFID=C1250. In this example assay, these observational units are also all within the same trial set, as defined in the TX dataset.

Dataset2

tableid	relref

Row	STUDYID	SETCD	REFID	PARENT	LEVEL	LVLDESC
1	123	A1	C0		1	EXPERIMENTAL UNIT/TRIAL SET
2	123	A1	C0-Count1	C0	2	OBSERVATIONAL UNIT
3	123	A1	C0-Count2	C0	2	OBSERVATIONAL UNIT
4	123	A1	C0-Count3	C0	2	OBSERVATIONAL UNIT
5	123	A1	C0-Count4	C0	2	OBSERVATIONAL UNIT
6	123	A2	C1250		1	EXPERIMENTAL UNIT/TRIAL SET
7	123	A2	C1250-Count1	C1250	2	OBSERVATIONAL UNIT
8	123	A2	C1250-Count2	C1250	2	OBSERVATIONAL UNIT
9	123	A2	C1250-Count3	C1250	2	OBSERVATIONAL UNIT
10	123	A2	C1250-Count4	C1250	2	OBSERVATIONAL UNIT

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

Dataset wrap

Name	gt

Rowcaps

Rows 1-3, 8:	Show percentage result values that apply to GTREFID=C0. REFID=C0, as shown in the RELREF dataset, relates this data to the trial set in the first row of table 1 in the sample report table for study 123.
Rows 4-7:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C0-Count1 through C0-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.
Rows 9-11, 16:	Show percentage result values that apply to GTREFID=C1250. REFID=C1250, as shown in the RELREF dataset, relates this data to the trial set in the second row of table 1 in the sample report table for study 123.
Rows 12-15:	Show the 4 micronucleated cell counts for the observational units with GTREFID from C1250-Count1 through C1250-Count4, for which their relationship to test conditions (in tx.xpt) and experimental units (in relref.xpt) are shown in the RELREF dataset.

Dataset2

Row	STUDYID	DOMAIN	GTSEQ	GTREFID	GTTESTCD	GTTEST	GTCELLEV	GTORRES	GTORRESU	GTCOLSRT

Expand

title	di.xpt (a study reference domain for unique device identification)

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

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