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Metadataspec |
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Num | Issue | Description and Resolution |
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1 | Data collection variable definitions are in draft. | Draft definitions for data collection variables are provided as part of metadata tables in Section x.x, Metadata for Individual Health. Draft definitions are in development as part of a separate initiative and, once finalized, will be updated in a future version of the TIG once finalized. | 2 | Tabulation and analysis standards for Product Description uand Product Impact on Population Health use cases. |
| 3 | The Product Description analysis structure |
| 4 | The REFERENCE data structure |
| 5 | Inconsistent use of "product" in the CDASH Model, the SDTM, and the ADaM ADaM.
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References to "treatment" in CDASH and ADaM models
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