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The TIG guides implementation for the following Trial Design datasets:
| Metadataspec |
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| Num | Dataset | Purpose |
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| 1 | Trial Arms |
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| (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 |
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(TE) | Represents the elements used in the trial. | | 3 | Trial Visits |
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| (TV) | Represents the planned schedule of visits. | | 4 | Trial Inclusion/Exclusion |
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| (TI) | Represents the criteria used to screen subjects. | | 5 | Trial Summary |
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| (TS) | Represents Lists key facts (parameters) about the trial that are likely to appear in a registry of clinical trials | | 6 | Trial Sets (TX) | Need more information here. Is this all datasets and do we have all examples? |
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Concepts specific to the Trial Design Model and subsequent datasets are described below. When concepts or aspects of concepts are related to either nonclinical studies or clinical trials but not both, this is denoted in the Description column.
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