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For tabulation datasets, conformance to standards is minimally ensured by:
| Metadataspec |
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Chris add DM back in (see ADaM) | Num | Conformance | Implementation |
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| 1 | Representing all collected, assigned, and relevant derived data in applicable datasets. | All data generated per scientific and regulatory requirements are included in tabulation datasets. | | 2 | Using domain specifications in this guide wherever applicable. | A dataset is created using a domain specification in this guide when the scientific nature or role of the data is within the scope of a domain. Domains are extended or custom domain specifications are only used when data are different in nature and are not in scope for domains in this guide. | | 3 | DM is created. | For studies that assess the impact of tobacco products on the health of individuals, DM is required even if no other datasets are generated. | | 4 | Following conventions for dataset naming. | The dataset name is standardized per naming conventions and per controlled terminology where applicable. | | 5 | Following guidance for dataset record structure. | Dataset content is aligned with the record structure specified per the domain specification. | | 6 | Following Core designations. | All Required and Expected tabulation variables are included as columns in the dataset. Required tabulation variables are populated for all records in the dataset. Permissible variables used to collect data are included in the dataset, even when no data for those variables were collected. | | 7 | Following conventions for variable naming. | The names of variables in the dataset are standardized per domain specifications and other applicable guidance. Controlled terminology for domain prefixes is used as specified for variable naming. | | 8 | Following conventions for variable labels. | The labels for variables in the dataset are standardized per domain specifications and other applicable guidance. | | 9 | Following guidance for variable types. | The variables in the dataset are standardized for either numeric or character values as specified per the domain specification. | | 10 | Populating variable values in alignment with this guide. | All variables in the dataset are populated as expected per this guide including per general and domain-specific guidance, controlled terminology, and formatting. |
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