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This example shows a subset of published controlled terminology parameters and the relationship of values across response variables TSVAL, TSVALNF, TSVALCD, TSVCDREF, and TSVCDVER.  Text over 200 characters can be added to additional columns TSVAL1-TSVALn. This example include the subset of terms that are CDISC and FDA required. When required items are not applicable TSVALNF may be used.

TSVALNF contains a “null flavor,” a value that provides additional coded information when TSVAL is null. For example, for TSPARM = "AGEMAX" (Planned Maximum Age of Subjects), there is no value if a study does not specify a maximum age. In this case, the appropriate null flavor is "PINF", which stands for "positive infinity." In a tobacco study conducted in healthy volunteers for a drug where the Trial Phase Classification is not established the null flavor for TSPARM = "TPHASE" would be "NA" (i.e., not applicable). TSVALNF can also be used in a case where the value of a particular parameter is unknown. 

ts.xpt

ts.xpt

RowSTUDYIDDOMAINTSSEQTSGRPIDTSPARMCDTSPARMTSVALTSVAL1TSVALNFTSVALCDTSVCDREFTSVCDVER
1XYZTS1
ACTSUBActual Number of Subjects304




2XYZTS1
ADAPTAdaptive DesignN




3XYZTS1
ADDONAdded on to Existing TreatmentsY

C49487CDISC CT2011-06-10
4XYZTS1
AGEMAXPlanned Maximum Age of SubjectsPINF




5XYZTS1
AGEMINPlanned Minimum Age of SubjectsP18M


ISO 8601
6XYZTS1PADCUTDTCData Cutoff Date2010-04-10


ISO 8601
7XYZTS1PADCUTDESCData Cutoff Description

PRIMARY ANALYSIS






8XYZTS1
FCNTRYPlanned Country of Investigational SitesUSA


ISO 3166-1 Alpha-3
9XYZTS2
FCNTRYPlanned Country of Investigational SitesCAN


ISO 3166-1 Alpha-3
10XYZTS1
HLTSUBJIHealthy Subject IndicatorNA

C48660CDISC CT2011-06-10
11XYZTS1
INDICTrial Disease/Condition IndicationTobacco smoking consumption

266918002SNOMED2011-03
12XYZTS1
LENGTHTrial LengthP3M


ISO 8601
13XYZTS1
NARMSPlanned Number of Arms3




14XYZTS1
OBJPRIMTrial Primary ObjectiveChange in concentration of Nicotine in urine from baseline




15XYZTS1
OBJSECTrial Secondary ObjectiveChange in concentration of Cotinine in urine from baseline




16XYZTS1
PLANSUBPlanned Number of Subjects300




17XYZTS1
RANDOMTrial is RandomizedY

C49488CDISC CT2011-06-10
18XYZTS1
REGIDRegistry IdentifierNCT123456789

NCT123456789ClinicalTrials.gov
19XYZTS2
REGIDRegistry IdentifierXXYYZZ456

XXYYZZ456EudraCT
20XYZTS1
SENDTCStudy End Date2011-04-01


ISO 8601
21XYZTS1
SEXPOPSex of ParticipantsBOTH

C49636CDISC CT2011-06-10
22XYZTS1
SPONSORClinical Study SponsorPharmaco

123456789

D-U-N-S NUMBER
23XYZTS1
STOPRULEStudy Stop RulesNONE




24XYZTS1
TITLETrial TitleA 3 month study of tobacco biomarkers in subjects using ENDS devices 




25XYZTS1
TBLINDTrial Blinding SchemaDOUBLE BLIND

C15228CDISC CT2011-06-10
26XYZTS1
TCNTRLControl TypeACTIVE

C49649CDISC CT2011-06-10
27XYZTS1
TITLETrial TitleA 3 month study of tobacco biomarkers in subjects using ENDS devices 




28XYZTS1
TDIGRPDiagnosis Group

NA


29XYZTS1
INDICTrial Disease/Condition IndicationTobacco smoking consumption

266918002SNOMED2011-03
30XYZTS1
TINDTPTrial Intent Type

NAC49656CDISC CT2011-06-10
31XYZTS1
TITLETrial TitleA 3 month study of tobacco biomarkers in subjects using ENDS devices 




32XYZTS1
TPHASETrial Phase Classification

NA


33XYZTS1
TTYPETrial TypeTOBACCO PRODUCT EFFECT

xxxxxxCDISC CTxxxxxxxxx
34XYZTS2


TTYPETrial TypeSAFETY




35XYZTS3


TTYPETrial TypePHARMACOKINETIC




36XYZTS1
SDTIGVERSDTM IG Version3.4




37XYZTS2
STDMVERSDTM Version1.4




38XYZTS3
TIG Version Tobacco IG Version1.0




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