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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 Text over 200 characters can be added to additional columns TSVAL1-TSVALn. This example does not inlcude include any text over 200 characters. A subset of the published terminology is Applicants should consult with regulators regarding which parameters are expected/required to be included in this datasetsubmitted. 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 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 Trial Phase Classification study/trial phase classification is not established the null flavor , the value (TSVAL) for TSPARM = "TPHASE" would be "NANOT APPLICABLE" (i.e., not applicable). TSVALNF can also be used in a case where the value of a particular parameter is unknown.  . 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 USA US and CANCanada. TSSEQ is assigned "1" for the USA US and "2" for CANCanada.   

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

Dataset wrap
Namets
C486602011-06-
Dataset2
RowSTUDYIDDOMAINTSSEQTSGRPIDTSPARMCDTSPARMTSVALTSVALNFTSVALCDTSVCDREFTSVCDVER
1XYZTS1
ACTSUBActual Number of Subjects304



2XYZTS1
ADAPTAdaptive DesignN



3XYZTS1
ADDONAdded on to Existing TreatmentsY
C49487CDISC CT
2011
2023-
06
03-
10
31
4XYZTS1
AGEMAXPlanned Maximum Age of SubjectsPINF



5XYZTS1
AGEMINPlanned Minimum Age of Subjects
P18M
P18Y

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
10XYZTS1HLTSUBJIHealthy Subject IndicatorNA
CDISC CT

10
11
XYZTS1
INDICTrial Disease/Condition IndicationTobacco smoking consumption
266918002SNOMED2011-03
12
11XYZTS1
LENGTHTrial LengthP3M

ISO 8601
13

12XYZTS1
NARMSPlanned Number of Arms3
14




13XYZTS1
OBJPRIMTrial Primary ObjectiveChange in concentration of Nicotine in urine from baseline
15




14XYZTS1
OBJSECTrial Secondary ObjectiveChange in concentration of Cotinine in urine from baseline
16




15XYZTS1
PLANSUBPlanned Number of Subjects300
17




16XYZTS1
RANDOMTrial is RandomizedY
C49488CDISC CT
2011
2023-
06
03-
10
31
18
17XYZTS1
REGIDRegistry IdentifierNCT123456789
NCT123456789ClinicalTrials.gov
19

18XYZTS2
REGIDRegistry IdentifierXXYYZZ456
XXYYZZ456EudraCT
20

19XYZTS1
SENDTCStudy End Date2011-04-01

ISO 8601
21

20XYZTS1
SEXPOPSex of ParticipantsBOTH
C49636CDISC CT
2011
2023-
06
03-
10
31
22
21XYZTS1
SPONSOR

APPLCNT
Clinical Study Sponsor

Applicant

Pharmaco
TobaccoCo

123456789

D-U-N-S NUMBER
23

22XYZTS1
STOPRULEStudy Stop RulesNONE
25




23XYZTS1
TBLINDTrial Blinding SchemaDOUBLE BLIND
C15228CDISC CT
2011
2023-
06
03-
10
31
26

24

XYZTS1
TCNTRLControl TypeACTIVE
C49649CDISC CT
2011
2023-
06
03-
10
31
27
25XYZTS1
TITLETrial TitleA 3 month study of tobacco biomarkers in subjects using ENDS devices
28




26XYZTS1
TDIGRPDiagnosis Group
NA
30



27XYZTS1
TINDTPTrial Intent Type
NAC49656CDISC CT
2011
2023-
06
03-
10
31
32
28XYZTS1
TPHASETrial Phase Classification
NA
NOT APPLICABLE
33




29XYZTS1
TTYPETrial Type
TOBACCO PRODUCT EFFECT
PHARMACOKINETIC
xxxxxx

C49663CDISC CT
xxxxxxxxx34
2023-03-31
30XYZTS
2
1
TTYPE

STYPE
Trial
Study Type
SAFETY
INTERVENTIONAL
3536

C98388
XYZTS3TTYPETrial TypePHARMACOKINETIC
CDISC CT2023-03-31
31
XYZTS1
SDTIGVERSDTM IG Version3.4
37




32XYZTS1
STDMVERSDTM Version1.4
38




33XYZTS1
TIGVERTobacco IG Version1.0