The CDISC ADaM Team announces the final release of the “Analysis Data Model Version 2.0”. This model combines the principles outlined in previously released ADaM documents “Statistical Analysis Dataset Model: General Considerations Version 1.0” and “Subject Level Analysis Model Version 0.21”. Significant restructuring of the two previous released models was conducted to produce a single document giving the user both a guide to important considerations for the creation of analysis datasets and a specific example of the core analysis file that should be created if any analysis files are submitted.
The ADaM team is working on an implementation guide that will build on the considerations discussed in the Analysis Data Model Version 2.0. This implementation guide will outline specific standards and recommendations for the structure and content of analysis data sets and will contain a library of examples of analysis data sets that would serve to support specific statistical methodology used within clinical trials, such as Change from Baseline, Time to Event, Categorical Analysis, and Adverse Event.