Page History

...

Expand

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

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
BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?

MNvitOECD Test 487 MNvit

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	ALLNRU	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
2	123	ALLNRU	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
3	123	ALLNRU	TS	1		STSTDTC	Study Start Date	2022-05-25
4	123	ALLNRU	TS	1		STITLE	Study Title	Determination of the in vitro genotoxicity potential of 10 tobacco products in both the in vitro Micronucleus Assay and the in vitro Neutral Red Uptake
5	123	ALLNRU	TS	1		SNDIGVER	SEND Implementation Guide Version	TOBACCO IMPLEMENTATION GUIDE VERSION 1.0
6	123	ALLNRU	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-09-30
7	123	ALLNRU	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
8	123	ALLNRU	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
9	123	ALLNRU	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
10	123	ALLNRU	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
11	123	ALLNRU	TS	1	1	TFCNTRY	Test Facility Country	USA
...12	123	ALLNRU	TS	1	1	STDIR	Study Director	Dr. R. Smith
13	123	ALLNRU	TS	1		GLPFL	GLP Flag	Y
14	123	NRU	TS	1		ASTD	Assay Standard	NIH Publication No.	07-4519
15	123	NRU	TS	1		ASTDV	Assay Standard Version	2016-07-29	123	MNvit	TS	1	SSTYP	Study Type	GENOTOXICITY IN VITRO	123	MNvit	TS	1	SSSTYP	Study Sub Type	In Vitro Micronucleus	123	MNvit	TS	1	SPECIES	Species	Homo Sapiens	123	MNvit	TS	1	??	Test System?	TK6 Lymphoblastoid Suspension Cells	2006-11
16	123	NRU	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	GENOTOXICITY IN VITRO
17	123	NRU	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake
18	123	NRU	TS	1		SPECIES	Species	Salmonella enterica
19	123	NRU	TS	1		??	Test System??	Normal Human Keratinocyte

1

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.
BLEO & CPA - are positive controls, should this be included/where is this captured? — in results for the record / row?
Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level

Row	STUDYID	ASSAYID	DOMAIN	SETCD	SET (what sponsor calls it)	TXPARMCD	TXPARM	TXVAL
1	123	NRU	TX	1-1-A (plate-col-row in the 96-well plate)	CSC-10 (through SLS-200)	PLATENUM. (e.g., 1 or 2)	1	1
2	123	NRU	TX	1-1-A	CSC-10	WELLNUM (e.g., 1-A through 10-H)	Number representing the location of the well in the 96-well plate	1-A
3	123	NRU	TX	1-1-A	CSC-10	INTRVN	name of the intervention article	Cigarette Smoke Condensate
4	123	NRU	TX	1-1-A	CSC-10	ITVTYPE (CT e.g, Product, positive control, negative control)	type of intervention article	PRODUCT
5	123	NRU	TX	1-1-A	CSC-10	ITVCONC	intervention concentration	10
6	123	NRU	TX	1-1-A	CSC-10	ITVCONCU	intervention unit	ug/ml
7	123	NRU	TX	1-1-A	CSC-10	STRAIN	Strain/Substrain	Salmonella enterica enterica
8	123	NRU	TX	1-1-A	CSC-10	REGIME	Smoking Regime	Traditional combustible
9	123

NRU

TX

1-1-A

CSC-10

NRU

		RUN	Assay run number (how is this different from REPNUM)	1
10	123	NRU	TX	1-1-A	CSC-10	PORT	Port ID	1
11	123	NRU	TX	1-1-A	CSC-10	SMPLID	Sample ID	030001
12	123	NRU	TX	1-1-A	CSC-10	SMKFRC	Smoke Fraction	A
13	123	NRU	TX	1-1-A	CSC-10	REPNUM	Replicate Number	1

11

14

123

NRU

TX

1-1-B

CSC-10

ITVCONC

intervention concentration

10

12

15	123	NRU	TX	1-1-B	CSC-10	ITVCONCU	intervention unit	ug/ml
...				...
	123	NRU	TX	1-10-H	SLS-10	PLATENUM	Plate number	1
	123	NRU	TX	1-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	1-10-H	SLS-10	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	1-10-H	SLS-10	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	1-10-H	SLS-10	ITVCONC	intervention concentration	200
	123	NRU	TX	1-10-H	SLS-10	ITVCONCU	intervention unit	ug/ml
...				...
	123	NRU	TX	2-10-H	SLS-10	PLATENUM	Plate number	2
	123	NRU	TX	2-10-H	SLS-10	WELLNUM	Number representing the location of the well in the 96-well plate	10-H
	123	NRU	TX	2-10-H	SLS-10	INTRVN	name of the intervention article	sodium laurel sulfate
	123	NRU	TX	2-10-H	SLS-10	ITVTYPE	type of intervention article	POSITIVE CONTROL
	123	NRU	TX	2-10-H	SLS-10	ITVCONC	intervention concentration	200
	123	NRU	TX	2-10-H	SLS-10	ITVCONCU	intervention unit	ug/ml

Page tree

Versions Compared

Old Version 14

New Version 15

Key

SET (what sponsor calls it)

(plate-col-row in the 96-well plate)

(through SLS-200)

PLATENUM. (e.g., 1 or 2)

WELLNUM (e.g., 1-A through 10-H)

(CT e.g, Product, positive control, negative control)