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

ts.xpt


STUDYIDDOMAINTSSEQTSGRPIDTSPARMCDTSPARMTSVALTSVALNF
1XYZTS1
SSTYPStudy TypeREPEAT DOSE TOXICITY
2XYZTS1
SPECIESSpeciesRAT
3XYZTS1
STRAINStrain/SubstrainFISCHER 344
4XYZTS1
SBSTRAINStrain/Substrain DetailsNON-DIABETIC OBESE RAT
5XYZTS1
SPLRNAMTest Subject SupplierExample Supplier
6XYZTS1
SDESIGNStudy DesignPARALLEL
7XYZTS1
ROUTERoute of AdministrationORAL
8XYZTS1
GLPTYPGood Laboratory Practice TypeFDA
9XYZTS2
GLPTYPGood Laboratory Practice TypeOECD
10XYZTS1
EXPSTDTCExperimental Start Date2008-01-01
11XYZTS1
EXPENDTCExperimental End Date2008-02-13
12XYZTS1
DOSDURDosing DurationP28D
13XYZTS1
STITLEStudy TitleExample of a 4-week Repeat-Dose Toxicity Study in Rats with a 1-week Recovery
14XYZTS1
SNDIGVERSEND Implementation Guide VersionSEND Implementation Guide Version 3.1.1
15XYZTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2023-06-30
16XYZTS1
STCATStudy CategoryTOX
17XYZTS1
APPLCNTApplicantExample Applicant Inc.
18XYZTS11TSTFNAMTest Facility NameExample Contract Lab Name
19XYZTS11TSTFLOCTest Facility Location1000 Anywhere Street, Honolulu, HI 11111
20XYZTS11TFCNTRYTest Facility CountryUSA
21XYZTS12TSNAMTest Site NameExample Subcontract Lab Name
22XYZTS12TSLOCTest Site Location1000 Allen Street Omaha, NE 88888
23XYZTS12TSCNTRYTest Site CountryUSA
24XYZTS1
STSTDTCStudy Start Date2007-12-30
25XYZTS1
STENDTCStudy End Date2008-06-01
26XYZTS1
AGETXTAge Text6-8
27XYZTS1
AGEUAge UnitWEEKS
28XYZTS11STDIRStudy DirectorDr. H. Someone
29XYZTS12PINVPrincipal InvestigatorG. Person
30XYZTS1
TRTInvestigational Therapy or TreatmentExample Compound Name
31XYZTS1
TRTVTreatment VehicleSALINE
32XYZTS1
GLPFLGLP FlagY
33XYZTS1
TRTCASPrimary Treatment CAS Registry Number
UNKNOWN
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