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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

Info
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)

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

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A2: Image Removed

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title	Study 123, Report Table

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

Row

STUDYID

ASSAYID

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

STSTDTC

Study Start Date

2022-05-25

4

123

MNvit

TS

1

STITLE

Study Title

Determination of the in vitro genotoxicity potential of 10 tobacco products in the in vitro Micronucleus Assay

5

123

MNvit

TS

1

SNDIGVER

SEND Implementation Guide Version

TOBACCO IMPLEMENTATION GUIDE VERSION 1.0

6

123

MNvit

TS

1

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-09-30

7

123

MNvit

TS

1

SSPONSOR

Sponsor Organization

Example Sponsor Inc.

8

123

MNvit

TS

1

SPREFID

Sponsor's Study Reference ID

NOT APPLICABLE

9

123

MNvit

TS

1

TSTFNAM

Test Facility Name

Example Tox Lab Name

10

123

MNvit

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

11

123

MNvit

TS

1

TFCNTRY

Test Facility Country

USA

12

123

MNvit

TS

1

STDIR

Study Director

Dr. R. Smith

13

123

MNvit

TS

1

GLPFL

GLP Flag

Y

14

123

MNvit

TS

1

ASTD

Assay Standard

OECD Test No. 487

15

123

MNvit

TS

1

ASTDV

Assay Standard Version

2016-07-29

16

123

MNvit

TS

1

SSTYP

Study Type

GENOTOXICITY IN VITRO

17

123

MNvit

TS

1

SSSTYP

Study Sub Type

In Vitro Micronucleus

18

123

MNvit

TS

1

SPECIES

Species

Homo Sapiens

19

123

MNvit

TS

1

??

Test System?

TK6 Lymphoblastoid Suspension Cells

20

123

MNvit

TS

1

SPDEVID

Sponsor defined device identifier

PUFFMASTER3K

21

123

MNvit

TS

1

DUREFID

Smoke Regimen

Medium Intensity Regimen

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title	tx.xpt (trial sets)

Row

STUDYID

ASSAYID

DOMAIN

SETCD

SET (what sponsor calls it)

TXSEQ

TXPARMCD

TXPARM

TXVAL

123

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

device in-use properties)

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).

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

...

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
1	123	DU	PUFFMASTER3K	1	Medium Intensity Regimen		PUFFPROF	Puff Profile	SQUARE		SQUARE
2	123	DU	PUFFMASTER3K	2	Medium Intensity Regimen		PUFFDUR	Puff Duration	1.25	sec	1.25	1.25	sec
3	123	DU	PUFFMASTER3K	3	Medium Intensity Regimen		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
4	123	DU	PUFFMASTER3K	4	Medium Intensity Regimen		PUFFBLCK	Puff Block	25	%	25	25	%
5	123	DU	PUFFMASTER3K	5	Medium Intensity Regimen		NUMPUFF	Total Number of Puffs	200	PUFF	200	200	PUFF
6	123	DU	PUFFMASTER3K	6	Medium Intensity Regimen		PUFFVOL	Puff Volume	10	mL	10	10	mL
7	123	DU	PUFFMASTER3K	7	Medium Intensity Regimen		PUFFRNG	Puff Range	100-200		100-200
8	123	DU	PUFFMASTER3K	8	Medium Intensity Regimen	1	PUFFPAUS	Puff Pause	60	s	60	60	s
9	123	DU	PUFFMASTER3K	9	Medium Intensity Regimen	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF
10	123	DU	PUFFMASTER2023	1	High Intensity Regimen		PUFFPROF	Puff Profile	SQUARE		SQUARE
11	123	DU	PUFFMASTER2023	2	High Intensity Regimen		PUFFDUR	Puff Duration	2.00	sec	2.00	2.00	sec
12	123	DU	PUFFMASTER2023	3	High Intensity Regimen		PUFFINT	Puff Interval	4	PUFF/min	4	4	PUFF/min
13	123	DU	PUFFMASTER2023	4	High Intensity Regimen		PUFFBLCK	Puff Block	0	%	0	0	%
14	123	DU	PUFFMASTER2023	5	High Intensity Regimen		NUMPUFF	Total Number of Puffs	200	PUFF	200	200	PUFF
15	123	DU	PUFFMASTER2023	6	High Intensity Regimen		PUFFVOL	Puff Volume	10	mL	10	10	mL
16	123	DU	PUFFMASTER2023	7	High Intensity Regimen		PUFFRNG	Puff Range	100-200		100-200
17	123	DU	PUFFMASTER2023	8	High Intensity Regimen	1	PUFFPAUS	Puff Pause	60	s	60	60	s
18	123	DU	PUFFMASTER2023	9	High Intensity Regimen	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF

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title	gt.xpt (similar to LB)

A1:

A2:

Row	STUDYID	ASSAYID	DOMAIN	TXSETCD	GTSEQ	GTTESTCD	GTTEST	GTCELLEV (cells evaluated)	GTORRES	GTORRESU	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC
1	123	MNvit	GT	A1	1	RICC	Relative Increase in Cell Count	0	0	%	0	0	%	2022-05-25
2	123	MNvit	GT	A1	2	RCC	Relative Cell Count	154	0	%	0	0	%	2022-05-25
3	123	MNvit	GT	A1	3	RPD	Relative Population Doubling	154	0	%	0	0	%	2022-05-25
4	123	MNvit	GT	A1	4	MNCELLS	Micronucleated Cells	2205	15	Cells	15	15	Cells	2022-05-25
5	123	MNvit	GT	A1	5	MNCELLS	Micronucleated Cells	2474	13	Cells	13	13	Cells	2022-05-25
6	123	MNvit	GT	A1	6	MNCELLS	Micronucleated Cells	2758	17	Cells	17	17	Cells	2022-05-25
7	123	MNvit	GT	A1	7	MNCELLS	Micronucleated Cells	2669	12	Cells	12	12	Cells	2022-05-25
8	123	MNvit	GT	A1	8	AVGREL	Average Relative MN Frequency		0.57	%	0.57	0.57	%	2022-05-25
9	123	MNvit	GT	A2	1	RICC	Relative Increase in Cell Count	134	15.7	%	15.7	15.7	%	2022-05-25
10	123	MNvit	GT	A2	2	RCC	Relative Cell Count	134	13.0	%	13.0	13.0	%	2022-05-25
11	123	MNvit	GT	A2	3	RPD	Relative Population Doubling	134	7.9	%	7.9	7.9	%	2022-05-25
12	123	MNvit	GT	A2	4	MNCELLS	Micronucleated Cells	3266	20	Cells	20	20	Cells	2022-05-25
13	123	MNvit	GT	A2	5	MNCELLS	Micronucleated Cells	2190	17	Cells	17	17	Cells	2022-05-25
14	123	MNvit	GT	A2	6	MNCELLS	Micronucleated Cells	2758	13	Cells	13	13	Cells	2022-05-25
15	123	MNvit	GT	A2	7	MNCELLS	Micronucleated Cells	2714	21	Cells	21	21	Cells	2022-05-25
16	123	MNvit	GT	A2	8	AVGREL	Average Relative MN Frequency		0.66	%	0.66	0.66	%	2022-05-25
...

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Key

SET (what sponsor calls it)