Customer Case Study: Overview of the CDISC Pilot Project

This talk discusses the goals, the process, and achievements of the CDISC Pilot Project to date. In particular, the talk reviews decisions made and actions taken to achieve the first CDISC Pilot submission to FDA in June 2006. The process for establishing FDA expectations and requirements, and the specifics of the structure of the first submission, is discussed. Subsequent comments on the submission package from FDA participants, and actions then taken to address those comments, are reviewed. No paper was submitted for publication. CONTACT INFORMATION Greg Anglin Eli Lilly and Co. SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration. Other brand and product names are trademarks of their respective companies. Life Sciences Focus Session SAS Global Forum 2007