• CDISC SDTM and DEFINE.XML data models 
• Data Standard Analysis and Review 
• Data Transformation Specification and Definition 
• Performing Data Transformation to Standards 
• Review and Validation of Transformations against CDISC guidelines 
• Generating  DEFINE.PDF and DEFINE.XML for data definition documentation

The regulatory requirements are going to include CDISC in the near future and the benefits are obvious. It is therefore wise and prudent to implement with techniques and processes refined from lessons learned based on real life implementations.

CDISC standards have been in development for many years. There have been structural changes to the recommended standards going forward from version 2 to 3. It is still an evolving process but it has reached a point of critical mass that organizations are recognizing the benefits of taking the proposed standard data model out of the theoretical and putting it into real life applications. The complexity of clinical data coupled with technologies involved can make implementation of a new standard challenging. This paper will explore the pitfalls and present methodologies and technologies that would make the transformation of nonstandard data into CDISC efficient and accurate. 

It is important to have a clear vision of the processes for the project before you start. This provides the ability to resource and plan for all the processes. This is an important step since the projects can push deadlines and break budgets due to the resource intensive nature of this effort. The organization and planning for this undertaking can become an essential first step towards an effective implementation.