| Num | Conformance | Implementation |
|---|
| 1 | ADaM fundamental principles are followed. | - Datasets and associated metadata clearly and unambiguously communicate the content and source of the datasets supporting the statistical analyses performed in a clinical study.
- Datasets and associated metadata 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 identify when and how analysis data have been derived or imputed.
- Datasets are readily usable with commonly available software tools.
- Datasets are associated with metadata to facilitate clear and unambiguous communication. Ideally the metadata are machine-readable.
- Datasets have a structure and content that allow statistical analyses to be performed with minimal programming. Such datasets are described as "analysis-ready." 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.
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| 2 | ADSL is created. | For studies that assess the impact of tobacco products on the health of individuals, ADSL and its related metadata are required even if no other analysis datasets are generated. |
| 3 | ADaM datasets follow the normative data found in the TIG. | Datasets follow the ADaM fundamental principles defined in the ADaM Model document and adheres as closely as possible to the TIG 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. These conventions must be followed for ADaM datasets with a CLASS value of BASIC DATA STRUCTURE, OCCURRENCE DATA STRUCTURE, and SUBJECT LEVEL ANALYSIS DATASET. Other analysis datasets should follow this convention where practical and feasible. |