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The TIG guides implementation for of the following Trial Design datasets:
| Metadataspec |
|---|
Purpose| Description |
|---|
| 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. | | 2 | Trial Elements (TE) |
| Represents the elements used in the trial. | | 3 | Trial Visits (TV) | Clinical Only | Represents the planned schedule of visits. | | 4 | Trial Inclusion/Exclusion (TI) | Clinical Only | Represents the criteria used to screen subjects. | | 5 | 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 | add text here |
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