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A trial design domain that contains one record for each trial summary characteristic. This domain is not subject oriented.

The Trial Summary (TS) dataset allows the applicant to submit a summary of the trial in a structured format. TOBA-323 - Getting issue details... STATUS Each record in the TS dataset contains the value of a parameter, a characteristic of the trial. For example, TS is used to record basic information about the study such as trial phase, protocol title, and trial objectives. The TS dataset contains information about the planned and actual trial characteristics.

Example

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 include any text over 200 characters. Applicants should consult with regulators regarding which parameters are expected/required to be submitted. 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." TSVALNF can also be used in a case where the value of a particular parameter is unknown.   However, in a tobacco study conducted in healthy volunteers where the study/trial phase classification is not established, the value (TSVAL) for TSPARM = "TPHASE" would be "NOT APPLICABLE". TSVAL should not be left null in this case. 

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 US and Canada. TSSEQ is assigned "1" for the US and "2" for Canada.   

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

ts.xpt

ts.xpt

RowSTUDYIDDOMAINTSSEQTSGRPIDTSPARMCDTSPARMTSVALTSVALNFTSVALCDTSVCDREFTSVCDVER
1XYZTS1
ACTSUBActual Number of Subjects304



2XYZTS1
ADAPTAdaptive DesignN



3XYZTS1
ADDONAdded on to Existing TreatmentsY
C49487CDISC CT2023-03-31
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
INDICTrial Disease/Condition IndicationTobacco smoking consumption
266918002SNOMED2011-03
11XYZTS1
LENGTHTrial LengthP3M

ISO 8601
12XYZTS1
NARMSPlanned Number of Arms3



13XYZTS1
OBJPRIMTrial Primary ObjectiveChange in concentration of Nicotine in urine from baseline



14XYZTS1
OBJSECTrial Secondary ObjectiveChange in concentration of Cotinine in urine from baseline



15XYZTS1
PLANSUBPlanned Number of Subjects300



16XYZTS1
RANDOMTrial is RandomizedY
C49488CDISC CT2023-03-31
17XYZTS1
REGIDRegistry IdentifierNCT123456789
NCT123456789ClinicalTrials.gov
18XYZTS2
REGIDRegistry IdentifierXXYYZZ456
XXYYZZ456EudraCT
19XYZTS1
SENDTCStudy End Date2011-04-01

ISO 8601
20XYZTS1
SEXPOPSex of ParticipantsBOTH
C49636CDISC CT2023-03-31
21XYZTS1
APPLCNT

Applicant

TobaccoCo

123456789

D-U-N-S NUMBER
22XYZTS1
STOPRULEStudy Stop RulesNONE



23XYZTS1
TBLINDTrial Blinding SchemaDOUBLE BLIND
C15228CDISC CT2023-03-31

24

XYZTS1
TCNTRLControl TypeACTIVE
C49649CDISC CT2023-03-31
25XYZTS1
TITLETrial TitleA 3 month study of tobacco biomarkers in subjects using ENDS devices



26XYZTS1
TDIGRPDiagnosis Group
NA


27XYZTS1
TINDTPTrial Intent Type
NAC49656CDISC CT2023-03-31
28XYZTS1
TPHASETrial Phase ClassificationNOT APPLICABLE



29XYZTS1
TTYPETrial TypePHARMACOKINETIC
C49663CDISC CT2023-03-31
30XYZTS1
STYPEStudy TypeINTERVENTIONAL
C98388CDISC CT2023-03-31
31XYZTS1
SDTIGVERSDTM IG Version3.4



32XYZTS1
STDMVERSDTM Version1.4



33XYZTS1
TIGVERTobacco IG Version1.0



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