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The TIG guides implementation of the following Trial Design datasets:
| Metadataspec |
|---|
TIG | Dataset | | Use Case | Dataset | Description |
|---|
| 1 | - Nonclinical
- Product Impact on Individual Health
| 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. | | 2 | - Nonclinical
- Product Impact on Individual Health
| Trial Elements (TE) | Represents the elements used in the trial. | | 3 | - Product Impact on Individual Health
| Trial Visits (TV) |
Clinical Only | Represents the planned schedule of visits. | | 4 | - Product Impact on Individual Health
| Trial Inclusion/Exclusion (TI) |
Clinical Only | | Represents the criteria used to screen subjects. | | 5 | - Nonclinical
- Product Impact on Individual Health
| Trial Summary (TS) | Represents Lists key facts (parameters) about the trial that are likely to appear in a registry of clinical trials | | 6 | | Trial Sets (TX) |
Nonclinical |