Interpreting CDISC ADaM IG through Users Interpretation

It is now almost three years CDISC ADaM is an official standard the pharmaceutical industries should consider in their processes and “eventually” for submission. However the learning curve has not yet reached the peak (like for SDTM?) and therefore, also because of the nature of ADaM, companies may have applied different interpretation. The aim of this paper is to have a systematic review of what has been published so far (CDISC, PharmaSUG, PhUSE, Forums, etc) and to evaluate how the different organizations have implemented and interpreted ADaM. Papers/slides have been identified and selected through a search on the web (e.g. Lex Jansen website indexing most of SAS proceedings). The key ‘learning’ from the most interesting “interpretation” will be discussed. The paper will also identify existing gray area; examples are but not limited to: - How to map clinical domains not yet covered - Complexity of data structure of developed ADaM datasets. E.g rules for creating derived records - Use of ADaM principles toward the ‘one-proc-away’ principle.