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title	ts.xpt Trial Summary Parameters (study level)

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title

ts.xpt

Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1

TS

1

SSTYP

Study Type

REPEAT DOSE TOXICITY

2

TS

1

SPECIES

Species

RAT

3

TS

1

STRAIN

Strain/Substrain

FISCHER 344

4

TS

1

SPLRNAM

Test Subject Supplier

HARLAN

5

TS

1

SDESIGN

Study Design

CROSSOVER

6

TS

1

ROUTE

Route of Administration

ORAL

7

TS

1

GLPTYP

Good Laboratory Practice Type

FDA

8

TS

1

EXPSTDTC

Experimental Start Date

2008-01-01

9

TS

1

EXPENDTC

Experimental End Date

2008-03-07

10

TS

1

TRMSAC

Time to Terminal Sacrifice

P42D

11

TS

1

STSTDTC

Study Start Date

2007-12-30

12

TS

1

DOSDUR

Dosing Duration

P42D

13

TS

1

STITLE

Study Title

Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods

14

TS

1

SNDIGVER

SEND Implementation Guide Version

SEND IMPLEMENTATION GUIDE VERSION 3.2

15

TS

1

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-03-26

16

TS

1

STCAT

Study Category

TOX

17

TS

1

SSPONSOR

Sponsor Organization

Example Sponsor Inc.

18

TS

1

SPREFID

Sponsor's Study Reference ID

NOT APPLICABLE

19

TS

1

TSTFNAM

Test Facility Name

Example Tox Lab Name

20

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

21

TS

1

TFCNTRY

Test Facility Country

USA

22

TS

1

AGETXT

Age Text

6-8

23

TS

1

AGEU

Age Unit

WEEKS

24

TS

1

STDIR

Study Director

Dr. R. Smith

25

TS

1

TRT

Investigational Therapy or Treatment

Drug A

26

TS

1

2

TRTV

Treatment Vehicle

Saline

27

TS

1

2

TRTVDESC

Treatment Vehicle Structured Description

100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}

28

TS

1

GLPFL

GLP Flag

Y

29

TS

1

TRTCAS

Primary Treatment CAS Registry Number

TEMPORARILY UNAVAILABLE

Expand

title	Full SEND ts.xpt FOR REFERENCE

Row

STUDYID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

1

TS

1

SSTYP

Study Type

REPEAT DOSE TOXICITY

2

TS

1

SPECIES

Species

RAT

3

TS

1

STRAIN

Strain/Substrain

FISCHER 344

4

TS

1

SPLRNAM

Test Subject Supplier

HARLAN

5

TS

1

SDESIGN

Study Design

CROSSOVER

6

TS

1

ROUTE

Route of Administration

ORAL

7

TS

1

GLPTYP

Good Laboratory Practice Type

FDA

8

TS

1

EXPSTDTC

Experimental Start Date

2008-01-01

9

TS

1

EXPENDTC

Experimental End Date

2008-03-07

10

TS

1

TRMSAC

Time to Terminal Sacrifice

P42D

11

TS

1

STSTDTC

Study Start Date

2007-12-30

12

TS

1

DOSDUR

Dosing Duration

P42D

13

TS

1

STITLE

Study Title

Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods

14

TS

1

SNDIGVER

SEND Implementation Guide Version

SEND IMPLEMENTATION GUIDE VERSION 3.2

15

TS

1

SNDCTVER

SEND Controlled Terminology Version

SEND Terminology 2021-03-26

16

TS

1

STCAT

Study Category

TOX

17

TS

1

SSPONSOR

Sponsor Organization

Example Sponsor Inc.

18

TS

1

SPREFID

Sponsor's Study Reference ID

NOT APPLICABLE

19

TS

1

TSTFNAM

Test Facility Name

Example Tox Lab Name

20

TS

1

TSTFLOC

Test Facility Location

10 Somewhere Street, Montgomery, AL 10000

21

TS

1

TFCNTRY

Test Facility Country

USA

22

TS

1

AGETXT

Age Text

6-8

23

TS

1

AGEU

Age Unit

WEEKS

24

TS

1

STDIR

Study Director

Dr. R. Smith

25

TS

1

TRT

Investigational Therapy or Treatment

Drug A

26

TS

1

2

TRTV

Treatment Vehicle

Saline

27

TS

1

2

TRTVDESC

Treatment Vehicle Structured Description

100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}

28

TS

1

GLPFL

GLP Flag

Y

29

TS

1

TRTCAS

Primary Treatment CAS Registry Number

TEMPORARILY UNAVAILABLE

Expand

title	ta.xpt (trial arms)

Row	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT




1	TA	ARM01-Prod1	Cigarette Smoke Condensate, 10 ug/mL	1	TREATMT	Treatment
9		9	SLS-110	1

...

Expand

title	tx.xpt (trial sets)

Expand

title	TX Domain

Red font (CT is coming!, POSITIVE CONTROL, VEHICLE CONTROL, etc.)

ARMCD. TREATMENT (element). SETCD

ARM01 TREATMT. CS-01. (Cigarette Smoke 10 ug/mL)

ARM01

TA.XPT

TRIAL ARMS

Row	DOMAIN	ARMCD	ARM	TAETORD	ETCD	ELEMENT





1	TA	ARM01-Prod1	Cigarette Smoke Condensate, 10 ug/mL	1	TREATMT	Treatment
2	TA	ARM02-Prod1	Cigarette Smoke Condensate, 50 ug/mL	1	TREATMT	Treatment
3	TA	ARM03-Prod1	Cigarette Smoke Condensate, 75 ug/mL	1	TREATMT	Treatment
4	TA	4		1
5	TA	5		1
6	TA	6		1
7		7		1
8		8		1
9		9	SLS-110	1
10		ARM10	SLS-200	1

TE.XPT

TRIAL ELEMENTS

Row	STUDYID	ASSAYID	DOMAIN	ETCD	ELEMENT
			TE	TREATMT	Treatment

tx.spt

TRIAL SET

example: Each plate has a separate product

Product, Smoking Regime (e.g. Traditional combustible, ENDS), Smoke Fraction, etc.

https://www.itis.gov/servlet/SingleRpt/SingleRpt?search_topic=TSN&search_value=969610#null

One study (Original sample of TK6 cells); (6 rows in GT)

Assay (MNT) (ran on 10 tobacco products)
3 assay/test conditions;
Treatment duration (2: ST, LT);
Presence of metabolic activation (2: presence, type)

Concentrations of product (6 of these: 0, x, y, z,..., +CNTL);
CytoTox % (3 different percentages from testing 1 portion of the original sample)
4 MN counts conducted (on 4 different portions of original sample?)

EID (5 of these, Count1 - Count4 and Cytotox): with many TX Parm codes

Cytotox: RICC, RIC, RPD, #cells

Assumption: ASSAYID value of ALL means it applies to all assays in the study

Row	STUDYID	ASSAYID	DOMAIN

SETCD

TSSEQ

SET

TSGRPID

TXSEQ

TSPARMCD

TXPARMCD

TSPARM

TXPARM

TSVAL

TXVAL

TSVALNF
1	123		TS	1		GLPTYP	Good Laboratory Practice Type	FDA
11	123		TS	1		STSTDTC	Study Start Date	2007-12-30
13	123		TS	1		STITLE	Study Title	Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14	123		TS	1		SNDIGVER	SEND Implementation Guide Version	Tobacco IMPLEMENTATION GUIDE VERSION 1.0
15	123		TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-03-26
17	123		TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
18	123		TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
19	123		TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
20	123		TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
21	123		TS	1	1	TFCNTRY	Test Facility Country	USA
24	123		TS	1	1	STDIR	Study Director	Dr. R. Smith
25	123		TS	1		TRT	Investigational Therapy or Treatment	Drug A
26	123		TS	1	2	TRTV	Treatment Vehicle	Saline
27	123		TS	1	2	TRTVDESC	Treatment Vehicle Structured Description	100.46 %(w/v) ISOTONIC SODIUM CHLORIDE SOLUTION {UNII VR5Y7PDT5W}
28	123		TS	1		GLPFL	GLP Flag	Y
29	123	MNT	TS	1		ASTD	Assay Standard	OECD Test No. 487
30	123	MNT	TS	1		ASTDV	Assay Standard Version	2016-07-29
31	123	MNT	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
32	123	MNT	TS	1		SSSTYP	Study Sub Type	In Vitro Micronucleus
33	123	MNT	TS	1		SPECIES	Species	Homo Sapiens
	123	MNT	TS	1		??	Test System?	TK6 Lymphoblastoid Suspension Cells
	123	NRU	TS	1		ASTD	Assay Standard	NIH Publication No. 07-4519
	123	NRU	TS	1		ASTDV	Assay Standard Version	2006-11
	123	NRU	TS	1		SSTYP	Study Type
	123	NRU	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake
	123	NRU	TS	1		SPECIES	Species	Homo Sapiens
	123	NRU	TS	1		??	Test System??	Normal Human Keratinocyte

ug/mL

Row	STUDYID	ASSAYID	DOMAIN	SETCD	TXPARMCD	TXPARM	TXVAL
1	123	1	TX	A	METACT	Metabolic Activation	+S9
		1		A	TRTDUR	Treatment Duration	Short Term
		1		A	PRDCONC	Concentration of product	1250
		1		A	PRDCONCU	Concentration Unit	ug/ml
		1		A
		1		A

					METACT	Metabolic Activation	-S9
					TRTDUR	Treatment Duration	Short Term
					TRTDUR	Treatment Duration	Long Term (or 2 parm codes, # and unit)
					PRDCONC	Concentration of product	0
					PRDCONCU	Concentration Unit	ug/ml
					Product	Product Name
						Smoking Regime
						Smoke Fraction	TX	METACT	Metabolic Activation	+S9	2	METACT	Metabolic Activation	-S9	TRTDUR	Treatment Duration	Short Term	TRTDUR	Treatment Duration	Long Term (or 2 parm codes, # and unit)	PRDCONC	Concentration of product	0	PRDCONCU	Concentration Unit	ug/ml	Product	Product Name	Smoking Regime	Smoke Fraction	TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	ARMCD	Arm Code	CS-10	TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	SPECIES	Species	Salmonella enterica	TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	STRAIN	Strain/Substrain	Salmonella enterica enterica	TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	PRODUCT	Product	product A	TX	CS-10	Cigarette Smoke Condensate, 10 ug/mL	REGIME	Smoking Regime	Traditional combustible	TX	CS-20	Cigarette Smoke Condensate, 50 ug/mL	ARMCD	Arm Code	CS-20	TX	CS-20	Cigarette Smoke Condensate, 50 ug/mL	PRODUCT	Product	product A	...	TX	LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	TRTDOS	Dose Level	100	TX	LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	TCNTRL	Control Type	POSITIVE CONTROL	TX	LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	CNTLAG	Control Agent	SODIUM LAURYL SULPHATE	TX	LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	CNTLAGAMT	Control Agent amount (levels)	110	LSL-200	sodium lauryl sulphate (SLS) positive control, 200 ug/mL	CNTLAGUNIT	Control Agent Unit

Expand

title	ei.xpt (dm-like)

1

Row

STUDYID

DOMAIN

ENID (Entity ID)

RICC

RCC

RPD

Sum of cell ev.

Cells with MN

SMKFID (Smoke Fraction)

REPLCTID

(Replicate Number)

PLATEID (Plate ID)

COLID

(Column number)

ROWID (Row number)

SETCD (Set Code, TX)

RFSTDTC

RFENDTC

RFXSTDTC

RFXENDTC

RFCSTDTC

RFCENDTC

ARMCD

030001

Expand

title	gt.xpt (similar to LB)

Row	STUDYID	DOMAIN	TXCD	GTSEQ	GTTESTCD	GTTEST	GTCELLEV (cells evaluated)	GTORRES	GTORRESU	GTSTRESC	GTSTRESN	GTSTRESU	GTDTC	GTNOMDY	GTELTM	GTTPTREF
1		GT

MA99999

GT

030001

A

1

A

CS-10

2008-04-01T06:00

2008-04-28T14:00

2008-04-02T14:00

2008-04-02T14:04

2008-04-01T06:00

3

2

MA99999

GT

1

1-1

A

1

RICC

1

134

BCS-102008-04-01T06:002008-04-21T14:002008-04-02T20:002008-04-02T20:042008-04-01T06:002008-04-01T06:003234

15.7	%	15.7	15.7	%	2022-05-25
2		GT	A	2	RCC		134	13.0	%	13.0	13.0	%	2022-05-25
3		GT	A	3	RPD		134	7.9	%	7.9	7.9	%	2022-05-25
4		GT	A	4	MNCELLS	Micronucleated Cells	3266	20	Cells	20	20	Cells	2022-05-25
5		GT	A	5	MNCELLS	Micronucleated Cells	2190	17	Cells	17	17	Cells	2022-05-25
6		GT	A	6	MNCELLS	Micronucleated Cells	7258	13	Cells	13	13	Cells	2022-05-25
7		GT	A	7	AVGREL	Average Relative MN Frequency		0.66	%	0.66	0.66	%	2022-05-25
8		GT
9		GT

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