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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 | Following conventions for dataset naming. | The dataset name is standardized per naming conventions and per controlled terminology where applicable. | | 4 | Following guidance for dataset record structure. | Dataset content is aligned with the record structure specified per the domain specification. | | 5 | 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. | | 6 | 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. | | 7 | Following conventions for variable labels. | The labels for variables in the dataset are standardized per domain specifications and other applicable guidance. | | 8 | Following guidance for variable types. | The variables in the dataset are standardized for either numeric or character values as specified per the domain specification. | | 9 | 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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| Metadataspec |
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| Num | Conformance | Implementation |
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| 1 | ADaM fundamental principles are followed | - ADaM datasets and associated metadata must clearly and unambiguously communicate the content and source of the datasets supporting the statistical analyses performed in a clinical study.
- ADaM datasets and associated metadata must provide traceability to show the source or derivation of a value or a variable (i.e., the data's lineage or relationship between a value and its predecessor(s)). The metadata must identify when and how analysis data have been derived or imputed.
- ADaM datasets must be readily usable with commonly available software tools.
- ADaM datasets must be associated with metadata to facilitate clear and unambiguous communication. Ideally the metadata are machine-readable
- ADaM datasets should have a structure and content that allow statistical analyses to be performed with minimal programming. Such datasets are described as "analysis-ready." ADaM datasets contain the data needed for the review and re-creation of specific statistical analyses. It is not necessary to collate data into analysis-ready datasets solely to support data listings or other non-analytical displays.
| | 2 | ADSL is submitted | For studies that assess the impact of tobacco products on the health of individuals, ADSL and its related metadata are required in a CDISC-based submission of data from a clinical trial even if no other analysis datasets are submitted. | | 3 | ADaM datasets follow the normative data found in the ADaMIGs | ADaM datasets must follow the ADaM fundamental principles defined in the ADaM Model document and adheres as closely as possible to the ADaMIG variable naming and other conventions. | | 4 | Traceability principles are followed | In the ADaM Model document, it is assumed that the original data sources for ADaM datasets are SDTM datasets, even when ADaM datasets are derived from other ADaM datasets. ADaM has features that enable traceability from analysis results to ADaM datasets and from ADaM datasets to SDTM datasets. |
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