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Metadataspec |
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Num | Dataset | Description | Use Case(s) |
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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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Trial Design datasets contain study-level, rather than subject-level, information. Implementation of Trial Design datasets requires the explicit statement of certain decision rules that may not be addressed or may not be as explicit in the textual description of a study plan such as an approved study protocol. Concepts specific to Trial Design datasets
and recommended steps for working through the design of a trial are also provided in this section.