Abstract 
As CDISC guidelines approach becoming a regulation, it is apparent that all submissions in the near future need to be compliant to SDTM, ADaM and documented in DEFINE.XML. This hands on workshop will dive right into the CDISC data modules working through real world scenarios dealing with transforming data into standards, validating all processes and documenting the metadata in XML. This includes some technical techniques using SAS while following the CDISC guidelines and also learning about XML. The FDA pilot has proven that CDISC is useful for both FDA reviewers and can also benefit sponsor companies to work with CDISC standards to ease data transfers between CROs and archival needs. 

Instructor Bio
Sy Truong is the cofounder and president of MXI (Meta-Xceed, Inc.) since 1997. MXI provides software solutions within the Pharmaceutical Industry specializing in CDISC data standards, SAS validation, electronic submission, data analysis and reporting. Sy is on the editorial board and contributor to the "Pharmaceutical Programming" journal. He is a frequent contributor and presenter at PharmaSUG, WUSS, and SAS Global Forum. He's currently writing a book for SAS Publishing entitled Becoming a SAS Clinical Trials Programmer.