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The TIG guides implementation of the following Trial Design datasets:
| Metadataspec |
|---|
| Num | Use Case | Dataset | Description | Use Case(s) |
|---|
| 1 | 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
| | 2 | Trial Elements (TE) | Represents the elements used in the trial. | 3- Nonclinical
- Product Impact on Individual Health
| | 3 | Trial Visits (TV) | Represents the planned schedule of visits. | 4 | Product Impact on Individual Health only | | 4 | Trial Inclusion/Exclusion (TI) | Represents the criteria used to screen subjects. | 5 | Nonclinical | Product Impact on Individual Health only | | 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
| | 6Nonclinical | Trial Sets (TX) | add text here | |
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