In vivo and in vitro Trial Summary (TS) Domain Model

The Trial Summary (TS) dataset allows the applicant to submit a summary of the study in a structured format. The TS dataset contains information about the planned study characteristics, identical for all study subjects, which is usually found in the protocol. Each record in the TS dataset contains the value of a parameter, a characteristic of the study, or study level information. TOBA-205 - Getting issue details... STATUS

Example: Simple Parallel Design With Recovery

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 recorded as an empty TSVAL and UNKNOWN in the corresponding TSVALNF.

ts.xpt

	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 3.1.1
15	XYZ	TS	1		SNDCTVER	SEND Controlled Terminology Version	SEND Terminology 2023-06-30
16	XYZ	TS	1		STCAT	Study Category	TOX
17	XYZ	TS	1		APPLCNT	Applicant	Example Applicant 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 Allen 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		AGETXT	Age Text	6-8
27	XYZ	TS	1		AGEU	Age Unit	WEEKS
28	XYZ	TS	1	1	STDIR	Study Director	Dr. H. Someone
29	XYZ	TS	1	2	PINV	Principal Investigator	G. Person
30	XYZ	TS	1		TRT	Investigational Therapy or Treatment	Example Compound Name
31	XYZ	TS	1		TRTV	Treatment Vehicle	SALINE
32	XYZ	TS	1		GLPFL	GLP Flag	Y
33	XYZ	TS	1		TRTCAS	Primary Treatment CAS Registry Number		UNKNOWN

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In vivo and in vitro Trial Summary (TS) Domain Model