The purpose of the SDTM Trial Design Model is to represent a brief, clear description of the overall plan and design of studies of tobacco products. Trial Design datasets contain study-level, rather than subject-level, information. The Trial Design datasets based on the Trial Design Model describe the planned design of the study and provide the representation of the study product in its most granular components, as well as the representation of all sequences of these components as described in the protocol. 

Guidance in this section is applicable to TIG Nonclinical and Product Impact on Individual Health use cases only. In this section, the term "trial" is equivalent to "study". The TIG guides implementation of the Trial Design datasets described in the following table for use cases as indicated. 

NumDatasetDescriptionUse Case(s)
1Trial Arms (TA)

Represents each planned arm in the study including the sequences of elements in each epoch for each arm. The TA and TE datasets are interrelated and provide the building blocks for subject-level information.

  • Nonclinical
  • Product Impact on Individual Health
2

Trial Elements (TE) 

Represents the elements used in the study including unique codes for each element, element descriptions, and the rules for starting and ending an element. The TA and TE datasets are interrelated and provide the building blocks for subject-level information.

  • Nonclinical
  • Product Impact on Individual Health
3Trial Visits (TV)Represents the planned order and number of visits in the study within each arm 
  • Product Impact on Individual Health
4Trial Inclusion/Exclusion (TI)

Represents the inclusion and exclusion criteria for the study


  • Product Impact on Individual Health
5Trial Summary (TS)

Represents key summary characteristics for the study

  • Nonclinical
  • Product Impact on Individual Health
6Trial Sets (TX)

Represents planned sets of subjects (e.g., in vivo studies) or sources of information (e.g., in vitro studies) that result from combinations of experimental factors defined for the study 

  • Nonclinical

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