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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 Assay

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

micronucleus assay.

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title	Sample Report Table for Study 123, Report Table

Image Modified

ASSAYID

Dataset wrap

Expand

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: 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

	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	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

SPREFID

APREFID

Sponsor's

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

GLPFLGLP FlagY14123

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

MNvit

TS

1

ASTD

2

Assay StandardOECD Test No. 487 15123

TSTGDORG	Testing Guideline Organization	OECD
16	123

MNvit

TS

1

ASTDV

2

TSTGDVER

Testing Guideline

Assay Standard

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

Homo Sapiens

HUMAN

19TS


20	123

MNvit

TS

1

??Test System?

CELLLN

Cell Line

TK6

Lymphoblastoid Suspension Cells20123MNvitTS1SPDEVIDSponsor defined device identifierPUFFMASTER3K21123MNvitTS1DUREFIDSmoke RegimenMedium Intensity Regimen Expand

title	tx.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

A1: Image Removed

A2: Image Removed

RowSTUDYIDASSAYIDDOMAINSETCD

SET (what sponsor calls it)

TXSEQTXPARMCDTXPARMTXVAL123

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

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

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 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 ABC001
Rows 5-8 show the records for a device given a SPDEVID of ABC999

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

MNvit

TX

A1

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

METACT

Metabolic Activation (should there be two parms? Presence, type)?

+S9

METACTFL

Y/N presence of metabolic activation

123

MNvit

TX

A1

TRTDRTRG

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

3

123

MNvit

TX

A1

TRTDRTOL

Treatment Duration Tolerance

123

MNvit

TX

A1

TRTDURU

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

H

123

MNvit

TX

A1

INTRVN

name of the intervention article

(Tobacco ProdA, Bleomycin or Cyclophosphamid A)

Tobacco ProdA

123

MNvit

TX

A1

ITVTYPE

type of intervention article

choices of values: product; negative control; positive control

Product

123

MNvit

TX

A1

ITVCONC

Concentration of intervention article

0

123

MNvit

TX

A1

ITVCONCU

Concentration Unit

ug/ml

123

MNvit

TS

A1

SPDEVID

Sponsor defined device identifier

PUFFMASTER3K

123

MNvit

TS

A1

DUREFID

Smoke Regimen

Medium Intensity Regimen

123

MNvit

TX

A2

(table 1, row 2)

METACT

Metabolic Activation (should there be two parms? Presence, type)?

+S9

123

MNvit

TX

A2

TRTDRTRG

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

3

123

MNvit

TX

A2

TRTDRTOL

Treatment Duration Tolerance

123

MNvit

TX

A2

TRTDURU

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

H

123

MNvit

TX

A2

INTRVN

name of the intervention article

Tobacco ProdA

123

MNvit

TX

A2

ITVTYPE

type of intervention article

Product

123

MNvit

TX

A2

ITVCONC

Concentration of i a

1250

123

MNvit

TX

A2

ITVCONCU

Concentration Unit

ug/ml

123

MNvit

TS

A2

SPDEVID

Sponsor defined device identifier

PUFFMASTER2023

123

MNvit

TS

A2

DUREFID

Smoke Regimen

High Intensity Regimen

...

Expand

title	du.xpt (device in-use properties)

Row

STUDYID

DOMAIN

SPDEVID

DUSEQ

DUREFID

DUGRPID

DUTESTCD

DUTEST

DUORRES

DUORRESU

DUSTRESC

DUSTRESN

DUSTRESU

1

123

DU

PUFFMASTER3K

1

Medium Intensity Regimen

PUFFPROF

Puff Profile

SQUARE

2

123

DU

PUFFMASTER3K

2

Medium Intensity Regimen

PUFFDUR

Puff Duration

1.25

sec

1.25

sec

3

123

DU

PUFFMASTER3K

3

Medium Intensity Regimen

PUFFINT

Puff Interval

3

PUFF/min

3

PUFF/min

4

123

DU

PUFFMASTER3K

4

Medium Intensity Regimen

PUFFBLCK

Puff Block

25

%

25

%

5

123

DU

PUFFMASTER3K

5

Medium Intensity Regimen

NUMPUFF

Total Number of Puffs

200

PUFF

200

PUFF

6

123

DU

PUFFMASTER3K

6

Medium Intensity Regimen

PUFFVOL

Puff Volume

10

mL

10

mL

7

123

DU

PUFFMASTER3K

7

Medium Intensity Regimen

PUFFRNG

Puff Range

100-200

8

123

DU

PUFFMASTER3K

8

Medium Intensity Regimen

1

PUFFPAUS

Puff Pause

60

s

60

s

9

123

DU

PUFFMASTER3K

9

Medium Intensity Regimen

1

PUFFPINT

Puff Pause Interval

10

PUFF

10

PUFF

10

123

DU

PUFFMASTER2023

1

Canadian Intense Regime

PUFFPROF

Puff Profile

SQUARE

11

123

DU

PUFFMASTER2023

2

Canadian Intense Regime

PUFFDUR

Puff Duration

2.00

sec

2.00

sec

12

123

DU

PUFFMASTER2023

3

Canadian Intense Regime

PUFFINT

Puff Interval

4

PUFF/min

4

PUFF/min

13

123

DU

PUFFMASTER2023

4

Canadian Intense Regime

PUFFBLCK

Puff Block

0

%

0

%

14

123

DU

PUFFMASTER2023

5

Canadian Intense Regime

NUMPUFF

Total Number of Puffs

200

PUFF

200

PUFF

15

123

DU

PUFFMASTER2023

6

Canadian Intense Regime

PUFFVOL

Puff Volume

10

mL

10

mL

16

123

DU

PUFFMASTER2023

7

Canadian Intense Regime

PUFFRNG

Puff Range

100-200

17

123

DU

PUFFMASTER2023

8

Canadian Intense Regime

1

PUFFPAUS

Puff Pause

60

s

60

s

18

123

DU

PUFFMASTER2023

9

Canadian Intense Regime

1

PUFFPINT

Puff Pause Interval

10

PUFF

10

PUFF

Expand

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	2011-001	DI	PUFFMASTER3K	1	DEVTYPETYPE	Device Type	MRIAll values in DIVAL corresponding to DEVTYPE in all examples need to be updated to conform with FDA Product Classification codes
2	2011-001	DI	PUFFMASTER3K	2	MANUF	Manufacturer	Acme Machines
3	2011-001	DI	PUFFMASTER3K	3	MODEL	Model Number	45-JFI
4	2011-001	DI	PUFFMASTER3K	4	SERIAL	Serial Number	456789132-AXQ
5	2011-001	DI	PUFFMASTER3K	5	FDAUDI	FDA Unique Device Identifier	456789123xyz
6	2015-001	DI	PUFFMASTER2023	1	DEVTYPETYPE	Device Type	MRI
7	2015-001	DI	PUFFMASTER2023	2	MANUF	Manufacturer	Acme Machines
8	2015-001	DI	PUFFMASTER2023	3	MODEL	Model Number	62-PLC
9	2015-001	DI	PUFFMASTER2023	4	SERIAL	Serial Number	215964564-NFS

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New Version Current

Key

SET (what sponsor calls it)