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.
a nonclinical study or clinical trial. 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" in the nonclinical context. Trial Design datasets contain study-level, rather than subject-level, information. Implementation of Trial Design datasets requires the explicit statement of certain decision rules that may not be addressed or may not be as explicit in the textual description of a study plan such as an approved study protocol.The TIG guides implementation for the following Trial Design datasets:. The TIG guides implementation of the Trial Design datasets described in the following table for use cases as indicated.
| Metadataspec |
|---|
Purpose| Description | Use Case(s) |
|---|
| 1 | Trial Arms (TA) | Represents each planned arm in the study including the sequences of elements in each epoch for each arm |
, and thus describes the complete sequence of elements in 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 trial.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
| | 3 | Trial Visits (TV) |
Clinical Only | schedule | order and number of visits |
.| in the study within each arm | - Product Impact on Individual Health
| | 4 | Trial Inclusion/Exclusion (TI) |
Clinical Only | criteria used to screen subjects.inclusion and exclusion criteria for the study
| - Product Impact on Individual Health
| | 5 | Trial Summary (TS) | Represents |
Lists key facts (parameters) about the trial that are likely to appear in a registry of clinical trialskey summary characteristics for the study | - Nonclinical
- Product Impact on Individual Health
| | 6 | Trial Sets (TX) |
Nonclinical | add text hereRepresents 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 | |
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