ADaM – The Analysis Dataset Model

What is ADaM?

The Analysis Dataset Model specifies data structures and associated metadata for analysis datasets.

In ADaM, variables, observations and even entire datasets may be derived to enable the scientific evaluation of the objectives of the clinical study. The content of these datasets is driven by the scientific and medical objectives of the study, with the overriding principle that the analysis datasets provide unambiguous communication regarding the analyses that were performed and the scientific and statistical rationale behind these analyses. 

ADaM has been carefully designed to provide a framework that enables reviewers to have a clear understanding of how the analysis datasets were derived and how they are to be used to produce the statistical results provided in the submission.

Business Benefits of Using ADaM

• consistent structure
• predictability of where to find important information relating to analysis decisions
• allows development of standard software tools that facilitate the access to, manipulation of, and viewing of the analysis datasets
• increases efficiency

You can find a Formedix presentation on ADaM on our downloads page.