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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

ts.xpt

RowSTUDYIDDOMAINTSSEQTSGRPIDTSPARMCDTSPARMTSVALTSVALNF
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 3.0
15XYZTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2011-01-07
16XYZTS1
STCATStudy CategoryTOX
17XYZTS1
SSPONSORSponsoring OrganizationExample Sponsor 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 Nowhere Street Omaha, NE 88888
23XYZTS12TSCNTRYTest Site CountryUSA
24XYZTS1
STSTDTCStudy Start Date2007-12-30
25XYZTS1
STENDTCStudy End Date2008-06-01
26XYZTS1
ASOCSTDYAssociated StudyAssociated pharmacokinetic Study
27XYZTS1
AGETXTAge Text6-8
28XYZTS1
AGEUAge UnitWEEKS
29XYZTS1
SPREFIDSponsor's Reference IDSP/StudyID
30XYZTS1
STMONSponsor's MonitorDr. J. Smith
31XYZTS11STDIRStudy DirectorDr. H. Someone
32XYZTS12PINVPrincipal InvestigatorG. Person
33XYZTS1
IDMETHMethod of IdentificationMICROCHIP
34XYZTS1
IACUCIACUC Number1234A
35XYZTS1
WATERDrinking WaterREVERSE OSMOSIS
36XYZTS1
ENVTEMPEnvironmental Temperature70-75
37XYZTS1
ENVTEMPUEnvironmental Temperature UnitsF
38XYZTS1
HUMIDTHousing Humidity10-30
39XYZTS1
HUMIDTUHousing Humidity Units%
40XYZTS1
LIGHTLight Cycle12 / 12
41XYZTS1
HOUSEGRPHousing GroupSINGLE
42XYZTS1
BEDDINGBeddingSTRAW
43XYZTS1
BEDCHNGBedding ChangeWEEKLY
44XYZTS1
MTHTRMMethod of TerminationCO2
45XYZTS1
DIETBasal DietSTANDARD
46XYZTS1
FEEDREGFeeding RegimenAD LIBITUM
47XYZTS1
INTSACTime to Interim SacrificeP14D
48XYZTS1
TRMSACTime to Terminal SacrificeP28D
49XYZTS1
RECSACRecovery PeriodP35D
50XYZTS1
TRTInvestigational Therapy or TreatmentExample Compound Name
51XYZTS1
TRTVTreatment VehicleSALINE
52XYZTS1
GLPFLGLP FlagY
53XYZTS1
TRTCASPrimary Treatment CAS Registry Number
UNK
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