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The TIG guides implementation of the Trial Design datasets described in the table below for use cases . A summary of concepts as indicated. Concepts
| Metadataspec |
|---|
| Num | Dataset | Description | Use Case(s) |
|---|
| 1 | Trial Arms (TA) | Represents 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. | - Nonclinical
- Product Impact on Individual Health
| | 3 | Trial Visits (TV) | Represents the planned schedule of visits. | - Product Impact on Individual Health
| | 4 | Trial Inclusion/Exclusion (TI) | Represents the criteria used to screen subjects. | - 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 trials | - Nonclinical
- Product Impact on Individual Health
| | 6 | Trial Sets (TX) | add text here | |
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