SEND Example.In vivo TS Example 1

In this example, the dataset includes many informational fields that may provide context for the study. TSPARMCD = "GLPTYP" is included twice in this example, since both GLP types apply for this study. Also, TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID = "1") and records related to the test site (TSGRPID = "2"). The study director is associated with the test facility and the principal investigator is associated with the test site. Finally, the primary treatment CAS Registry Number is not known; this is recroded as an empty TSVAL and UNK in the corresponding TSVALNF.

ts.xpt

Row	STUDYID	DOMAIN	TSSEQ	TSGRPID	TSPARMCD	TSPARM	TSVAL	TSVALNF
1	XYZ	TS	1		SSTYP	Study Type	REPEAT DOSE TOXICITY
2	XYZ	TS	1		SPECIES	Species	RAT
3	XYZ	TS	1		STRAIN	Strain/Substrain	FISCHER 344
4	XYZ	TS	1		SBSTRAIN	Strain/Substrain Details	NON-DIABETIC OBESE RAT
5	XYZ	TS	1		SPLRNAM	Test Subject Supplier	Example Supplier
6	XYZ	TS	1		SDESIGN	Study Design	PARALLEL
7	XYZ	TS	1		ROUTE	Route of Administration	ORAL
8	XYZ	TS	1		GLPTYP	Good Laboratory Practice Type	FDA
9	XYZ	TS	2		GLPTYP	Good Laboratory Practice Type	OECD
10	XYZ	TS	1		EXPSTDTC	Experimental Start Date	2008-01-01
11	XYZ	TS	1		EXPENDTC	Experimental End Date	2008-02-13
12	XYZ	TS	1		DOSDUR	Dosing Duration	P28D
13	XYZ	TS	1		STITLE	Study Title	Example of a 4-week Repeat-Dose Toxicity Study in Rats with a 1-week Recovery
14	XYZ	TS	1		SNDIGVER	SEND Implementation Guide Version	SEND Implementation Guide Version 3.0
15	XYZ	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2011-01-07
16	XYZ	TS	1		STCAT	Study Category	TOX
17	XYZ	TS	1		SSPONSOR	Sponsoring Organization	Example Sponsor Inc.
18	XYZ	TS	1	1	TSTFNAM	Test Facility Name	Example Contract Lab Name
19	XYZ	TS	1	1	TSTFLOC	Test Facility Location	1000 Anywhere Street, Honolulu, HI 11111
20	XYZ	TS	1	1	TFCNTRY	Test Facility Country	USA
21	XYZ	TS	1	2	TSNAM	Test Site Name	Example Subcontract Lab Name
22	XYZ	TS	1	2	TSLOC	Test Site Location	1000 Nowhere Street Omaha, NE 88888
23	XYZ	TS	1	2	TSCNTRY	Test Site Country	USA
24	XYZ	TS	1		STSTDTC	Study Start Date	2007-12-30
25	XYZ	TS	1		STENDTC	Study End Date	2008-06-01
26	XYZ	TS	1		ASOCSTDY	Associated Study	Associated pharmacokinetic Study
27	XYZ	TS	1		AGETXT	Age Text	6-8
28	XYZ	TS	1		AGEU	Age Unit	WEEKS
29	XYZ	TS	1		SPREFID	Sponsor's Reference ID	SP/StudyID
30	XYZ	TS	1		STMON	Sponsor's Monitor	Dr. J. Smith
31	XYZ	TS	1	1	STDIR	Study Director	Dr. H. Someone
32	XYZ	TS	1	2	PINV	Principal Investigator	G. Person
33	XYZ	TS	1		IDMETH	Method of Identification	MICROCHIP
34	XYZ	TS	1		IACUC	IACUC Number	1234A
35	XYZ	TS	1		WATER	Drinking Water	REVERSE OSMOSIS
36	XYZ	TS	1		ENVTEMP	Environmental Temperature	70-75
37	XYZ	TS	1		ENVTEMPU	Environmental Temperature Units	F
38	XYZ	TS	1		HUMIDT	Housing Humidity	10-30
39	XYZ	TS	1		HUMIDTU	Housing Humidity Units	%
40	XYZ	TS	1		LIGHT	Light Cycle	12 / 12
41	XYZ	TS	1		HOUSEGRP	Housing Group	SINGLE
42	XYZ	TS	1		BEDDING	Bedding	STRAW
43	XYZ	TS	1		BEDCHNG	Bedding Change	WEEKLY
44	XYZ	TS	1		MTHTRM	Method of Termination	CO2
45	XYZ	TS	1		DIET	Basal Diet	STANDARD
46	XYZ	TS	1		FEEDREG	Feeding Regimen	AD LIBITUM
47	XYZ	TS	1		INTSAC	Time to Interim Sacrifice	P14D
48	XYZ	TS	1		TRMSAC	Time to Terminal Sacrifice	P28D
49	XYZ	TS	1		RECSAC	Recovery Period	P35D
50	XYZ	TS	1		TRT	Investigational Therapy or Treatment	Example Compound Name
51	XYZ	TS	1		TRTV	Treatment Vehicle	SALINE
52	XYZ	TS	1		GLPFL	GLP Flag	Y
53	XYZ	TS	1		TRTCAS	Primary Treatment CAS Registry Number		UNK

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SEND Example.In vivo TS Example 1