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.
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| Row | STUDYID | DOMAIN | TSSEQ | TSGRPID | TSPARMCD | TSPARM | TSVAL | TSVALNF | TSVALCD | TSVCDREF | TSVCDVER |
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| 1 | XYZ | TS | 1 |
| ACTSUB | Actual Number of Subjects | 304 |
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| | 2 | XYZ | TS | 1 |
| ADAPT | Adaptive Design | N |
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| | 3 | XYZ | TS | 1 |
| ADDON | Added on to Existing Treatments | Y |
| C49487 | CDISC CT | 2011-06-10 | | 4 | XYZ | TS | 1 |
| AGEMAX | Planned Maximum Age of Subjects | PINF |
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| | 5 | XYZ | TS | 1 |
| AGEMIN | Planned Minimum Age of Subjects | P18M |
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| ISO 8601 |
| | 6 | XYZ | TS | 1 | PA | DCUTDTC | Data Cutoff Date | 2010-04-10 |
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| ISO 8601 |
| | 7 | XYZ | TS | 1 | PA | DCUTDESC | Data Cutoff Description | PRIMARY ANALYSIS |
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| | 8 | XYZ | TS | 1 |
| FCNTRY | Planned Country of Investigational Sites | USA |
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| ISO 3166-1 Alpha-3 |
| | 9 | XYZ | TS | 2 |
| FCNTRY | Planned Country of Investigational Sites | CAN |
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| ISO 3166-1 Alpha-3 |
| | 10 | XYZ | TS | 1 |
| HLTSUBJI | Healthy Subject Indicator | NA |
| C48660 | CDISC CT | 2011-06-10 | | 11 | XYZ | TS | 1 |
| INDIC | Trial Disease/Condition Indication | Tobacco smoking consumption |
| 266918002 | SNOMED | 2011-03 | | 12 | XYZ | TS | 1 |
| LENGTH | Trial Length | P3M |
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| ISO 8601 |
| | 13 | XYZ | TS | 1 |
| NARMS | Planned Number of Arms | 3 |
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| | 14 | XYZ | TS | 1 |
| OBJPRIM | Trial Primary Objective | Change in concentration of Nicotine in urine from baseline |
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| | 15 | XYZ | TS | 1 |
| OBJSEC | Trial Secondary Objective | Change in concentration of Cotinine in urine from baseline |
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| | 16 | XYZ | TS | 1 |
| PLANSUB | Planned Number of Subjects | 300 |
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| | 17 | XYZ | TS | 1 |
| RANDOM | Trial is Randomized | Y |
| C49488 | CDISC CT | 2011-06-10 | | 18 | XYZ | TS | 1 |
| REGID | Registry Identifier | NCT123456789 |
| NCT123456789 | ClinicalTrials.gov |
| | 19 | XYZ | TS | 2 |
| REGID | Registry Identifier | XXYYZZ456 |
| XXYYZZ456 | EudraCT |
| | 20 | XYZ | TS | 1 |
| SENDTC | Study End Date | 2011-04-01 |
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| ISO 8601 |
| | 21 | XYZ | TS | 1 |
| SEXPOP | Sex of Participants | BOTH |
| C49636 | CDISC CT | 2011-06-10 | | 22 | XYZ | TS | 1 |
| SPONSOR | Clinical Study Sponsor | Pharmaco |
| | D-U-N-S NUMBER |
| | 23 | XYZ | TS | 1 |
| STOPRULE | Study Stop Rules | NONE |
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| | 25 | XYZ | TS | 1 |
| TBLIND | Trial Blinding Schema | DOUBLE BLIND |
| C15228 | CDISC CT | 2011-06-10 | | 26 | XYZ | TS | 1 |
| TCNTRL | Control Type | ACTIVE |
| C49649 | CDISC CT | 2011-06-10 | | 27 | XYZ | TS | 1 |
| TITLE | Trial Title | A 3 month study of tobacco biomarkers in subjects using ENDS devices |
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| | 28 | XYZ | TS | 1 |
| TDIGRP | Diagnosis Group |
| NA |
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| | 30 | XYZ | TS | 1 |
| TINDTP | Trial Intent Type |
| NA | C49656 | CDISC CT | 2011-06-10 | | 32 | XYZ | TS | 1 |
| TPHASE | Trial Phase Classification |
| NA |
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| | 33 | XYZ | TS | 1 |
| TTYPE | Trial Type | TOBACCO PRODUCT EFFECT |
| xxxxxx | CDISC CT | xxxxxxxxx | | 34 | XYZ | TS | 2 |
| TTYPE | Trial Type | SAFETY |
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| | 35 | XYZ | TS | 3 |
| TTYPE | Trial Type | PHARMACOKINETIC |
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| | 36 | XYZ | TS | 1 |
| SDTIGVER | SDTM IG Version | 3.4 |
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| | 37 | XYZ | TS | 1 |
| STDMVER | SDTM Version | 1.4 |
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| | 38 | XYZ | TS | 1 |
| TIGVER | Tobacco IG Version | 1.0 |
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