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NSERT Figure 1.6.1 Categories of Analysis Datasets

Fundamental Principles 

• ADaM datasets must adhere to certain fundamental principles as described in the ADaM Model document:
  • 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.

Traceability