The purpose of the SDTM Trial Design Model is to represent a brief, clear description of the overall plan and design of 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. The TIG guides implementation of the Trial Design datasets described in the table below for use cases as indicated.
| Metadataspec |
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| Num | Dataset | DescriptionPurpose | Use Case(s) |
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| 1 | Trial Arms (TA) | Represents each planned arm in the trial including the sequences of elements in each epoch for each arm , and thus describes the complete sequence of elements in each arm. | - Nonclinical
- Product Impact on Individual Health
| | 2 | Trial Elements (TE) | Represents the elements used in the trial including unique codes for each element, element descriptions, and the rules for starting and ending an element. | - Nonclinical
- Product Impact on Individual Health
| | 3 | Trial Visits (TV) | Represents the planned schedule order and number of visits in the trial within each arm. | - Product Impact on Individual Health
| | 4 | Trial Inclusion/Exclusion (TI) | Represents the criteria used to screen subjectsinclusion and exclusion criteria for the trial.
| - 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 trial. | - Nonclinical
- Product Impact on Individual Health
| | 6 | Trial Sets (TX)add text here | Represents planned sets of subjects that result from combinations of experimental factors defined for the trial. | |
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