Fundamental principals of the ADaM standard

Analysis datasets must maintain the following principal;

1. Analysis dataset and associated metadata must clearly and unambiguously communicate the content and source of the datasets supporting the statistical analyses performed in a clinical study.
   
   
2. Analysis dataset and associated metadata must provide trace-ability to allow an understanding of where an analysis value came from. The metadata must also identify when analysis data have been derived or imputed.
   
   
3. Analysis dataset must be readily usable with common available software tools.
   
   
4. Analysis dataset must be associated with metadata to facilitate clear and unambiguous communication. Ideally the metadata are machine-readable.
   
   
5. Analysis dataset should have a structure and content that allow statistical analysis to be performed with minimal programming. Such datasets are called "analysis-ready".