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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 does not inlcude any text over 200 characters. A subset of the published terminology is required to be included in this dataset. 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 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.  

Sequence number is given to ensure uniqueness within a parameter. In this example, TSPARMCD, FCNTRY, is repeated twice to indicate that the study was conducted in the USA and CAN. TSSEQ is assigned "1" for the USA and "2" for CAN.   

TSGRPID is used to tie together a group of related records. For example, DCUTDTC, and DCUTDESC below are tie together using TSGRPID.  

ts.xpt

ts.xpt

RowSTUDYIDDOMAINTSSEQTSGRPIDTSPARMCDTSPARMTSVALTSVALNFTSVALCDTSVCDREFTSVCDVER
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 SubjectsP18Y

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
APPLCNT

Applicant TOBA-321 - Jira project doesn't exist or you don't have permission to view it.

TobaccoCo

123456789

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



24XYZTS1
TBLINDTrial Blinding SchemaDOUBLE BLIND
C15228CDISC CT2011-06-10

25

XYZTS1
TCNTRLControl TypeACTIVE
C49649CDISC CT2011-06-10
26XYZTS1
TITLETrial TitleA 3 month study of tobacco biomarkers in subjects using ENDS devices



27XYZTS1
TDIGRPDiagnosis Group
NA


28XYZTS1
TINDTPTrial Intent Type
NAC49656CDISC CT2011-06-10
29XYZTS1
TPHASETrial Phase Classification
NA


30XYZTS1
TTYPETrial TypePHARMACOKINETIC
C49663CDISC CT2023-03-31
31XYZTS1
SDTIGVERSDTM IG Version3.4



32XYZTS1
STDMVERSDTM Version1.4



33XYZTS1
TIGVERTobacco IG Version TOBA-322 - Jira project doesn't exist or you don't have permission to view it. 1.0



Dataset Debug Message

When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.

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