RL39 Experience with CDISC and Why Statisticians Need to be Involved
*Phillip Pichotta, Statistical Consultant 


CDISC is an organization to provide standards for interchange of clinical data. The SDTM model provides standards for raw datasets and ADaM model provides standards for analysis datasets. CDASH, under development, will provide standards about what data will be collected and how it will be collected. The CDISC standards will be helpful but statisticians need understand potential pitfalls. Statisticians need to understand these standards and become involved in their development to ensure that they are useful.