...
For analysis datasets, conformance to standards is minimally ensured by:Add draft text here.
| Metadataspec |
|---|
| Num | Conformance | Implementation |
|---|
| 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 | 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. |
|
...