Page History

...

Expand

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

Assumption: Study can have more than one assay type
Assumption: ASSAYID value of ALL means it applies to all assays in the study
Replaced ivMN with ivMN the ASSAYID values of MNT with MNvit (term used in OECD #487) - is this better? This is not a controlled term so we can use anything but what we use in our IG examples are often used in industry implementations so we should use realistic and best practice values as much as possible.
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)

Row	STUDYID	ASSAYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	123	ALL	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
11	123	ALL	TS	1		STSTDTC	Study Start Date	2007-12-30
13	123	ALL	TS	1		STITLE	Study Title	Example of a Crossover study in the Rat with 3 dose levels and 3 dosing periods
14	123	ALL	TS	1		SNDIGVER	SEND Implementation Guide Version	Tobacco IMPLEMENTATION GUIDE VERSION 1.0
15	123	ALL	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2021-03-26
17	123	ALL	TS	1		SSPONSOR	Sponsor Organization	Example Sponsor Inc.
18	123	ALL	TS	1		SPREFID	Sponsor's Study Reference ID		NOT APPLICABLE
19	123	ALL	TS	1	1	TSTFNAM	Test Facility Name	Example Tox Lab Name
20	123	ALL	TS	1	1	TSTFLOC	Test Facility Location	10 Somewhere Street, Montgomery, AL 10000
21	123	ALL	TS	1	1	TFCNTRY	Test Facility Country	USA
24	123	ALL	TS	1	1	STDIR	Study Director	Dr. R. Smith
28	123	ALL	TS	1		GLPFL	GLP Flag	Y
29	123	ivMNMNvit	TS	1		ASTD	Assay Standard	OECD Test No. 487
30	123	ivMNMNvit	TS	1		ASTDV	Assay Standard Version	2016-07-29
31	123	ivMNMNvit	TS	1		SSTYP	Study Type	GENOTOXICITY IN VITRO
32	123	ivMNMNvit	TS	1		SSSTYP	Study Sub Type	In Vitro Micronucleus
33	123	ivMNMNvit	TS	1		SPECIES	Species	Homo Sapiens
34	123	ivMNMNvit	TS	1		??	Test System?	TK6 Lymphoblastoid Suspension Cells
35	123	NRU	TS	1		ASTD	Assay Standard	NIH Publication No. 07-4519
36	123	NRU	TS	1		ASTDV	Assay Standard Version	2006-11
37	123	NRU	TS	1		SSTYP	Study Type
38	123	NRU	TS	1		SSSTYP	Study Sub Type	In Vitro Neutral Red Uptake
39	123	NRU	TS	1		SPECIES	Species	Homo Sapiens
40	123	NRU	TS	1		??	Test System??	Normal Human Keratinocyte

Expand

title	tx.xpt (trial sets)

Treatment Duration will be controlled? During CT definition/reviews will need to decide appropriate Treatment duration values; For now, we just include good example values based on our experience

Row	STUDYID	ASSAYID	DOMAIN	SETCD	TXPARMCD	TXPARM	TXVAL
1	123	ivMNMNvit	TX	A1	METACT	Metabolic Activation (should there be two parms? Presence, type)?	+S9
2	123	ivMNMNvit	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

					TRTDRTOL	Treatment Duration Tolerance
					TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
3	123	ivMNMNvit	TX	A1	PRDCONC	Concentration of product	0
4	123	ivMNMNvit	TX	A1	PRDCONCU	Concentration Unit	ug/ml
5	123	ivMNMNvit	TX	A1	Product	Product Name
6	123	ivMNMNvit	TX	A1		Smoking Regime
7	123	ivMNMNvit	TX	A1		Smoke Fraction
	123	ivMNMNvit	TX	A2	METACT	Metabolic Activation	+S9
	123	ivMNMNvit	TX	A2	TRTDUR	Treatment Duration	Short Term
	123	ivMNMNvit	TX	A2	PRDCONC	Concentration of product	1250
	123	ivMNMNvit	TX	A2	PRDCONCU	Concentration Unit	ug/ml
	123	ivMNMNvit	TX	A2	Product	Product Name
	123	ivMNMNvit	TX	A2		Smoking Regime
	123	ivMNMNvit	TX	A2		Smoke Fraction
	123	ivMNMNvit	TX	B1	METACT	Metabolic Activation	-S9
	123	ivMNMNvit	TX	B1	TRTDRTRG	Treatment Duration target	4
					TRTDRTOL	Treatment Duration Tolerance	.25
??	123	ivMNMNvit	TX	B1	TRTDURU	Treatment Duration Unit (this is for both TRTDURT, TRTDURTOL)	H
	123	ivMNMNvit	TX	B1	PRDCONC	Concentration of product	0
	123	ivMNMNvit	TX	B1	PRDCONCU	Concentration Unit	ug/ml
	123	ivMNMNvit	TX	B1	Product	Product Name
	123	ivMNMNvit	TX	B1		Smoking Regime
	123	ivMNMNvit	TX	B1		Smoke Fraction
	123	ivMNMNvit	TX	C1	METACT	Metabolic Activation	-S9
	123	ivMNMNvit	TX	C1	TRTDUR	Treatment Duration	24
??	123	ivMNMNvit	TX	C1	TRTDURU	Treatment Duration Unit	H
	123	ivMNMNvit	TX	C1	PRDCONC	Concentration of product	0
	123	ivMNMNvit	TX	C1	PRDCONCU	Concentration Unit	ug/ml
	123	ivMNMNvit	TX	C1	Product	Product Name
	123	ivMNMNvit	TX	C1		Smoking Regime
	123	ivMNMNvit	TX	C1		Smoke Fraction

Expand

title	gt.xpt (similar to LB)

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

...

Page tree

Versions Compared

Old Version 30

New Version 31

Key