The Clinical Data Interchange Standards Consortium (CDISC) has been the primary driver for standards development in Clinical Research for nearly 10 years.  During this period, CDISC has demonstrated the diverse business benefits that can accrue from the use of data standards, and has achieved broad consensus support among sponsors, vendors, CROs and Regulatory authorities for a broad suite of clinical research data standards including the SDTM, SEND, ODM, ADaM, Define.xml, LAB, CDASH.  Use of the SDTM in particular has been endorsed by FDA since 2004, and uses of the other standards has been rapidly growing in acceptance in recent years. The purpose of this seminar is to present a general introduction to the world of CDISC.  The seminar will review the CDISC organization and its resources, and provide attendees with a basic understanding of all of the major standards and recommendations for how they can best be applied now and in the future.  The presentation will focus on the SDTM in particular as a starting point for exposure to CDISC, and conclude with a discussion of the current high priority strategic projects currently being pursued y CDISC.

Benefits to the Participants

Receive broad, general introduction to the history, organization, activities, products and plans of the Clinical Data Interchange Standards Consortium (CDISC) Gain a fundamental understanding of the principal standards provided by CDISC:  SDTM, ODM, ADaM, LAB, SEND, Define.xml, Terminology, CDASH and Glossary. Hear practical advice on how to use CDISC standards effectively. Learn about other significant CDISC projects such as the structured protocol, the BRIDG model, and Healthcare Links. Discuss examples of how CDISC projects are being applied in industry among sponsors, technology vendors, service providers and FDA.

Issues to be covered

CDISC – History, mission and organization. CDISC resources, project teams and user communities around the world.  Introduction to the principle CDISC standards Case study:  understanding and using the SDTM Recommendations for applying CDISC standards CDISC strategic projects:  the technical harmonization roadmap,the BioResearch Integrated Domain Group (BRIDG) model, and Healthcare Links CDISC standards relevant to FDA and the CDISC/FDA pilot projects CDISC/HL7 collaborative projects

Who should attend

Clinical Trials professionals responsible for clinical data management and reporting Project managers, clinical researchers and statisticians involved in protocol design, data management and data analysis processes  Regulatory Affairs professionals and personnel involved in the preparation of electronic regulatory submissions

About the Speaker

Mr. Kubick was a founding Director of CDISC who led development of the SDTM. A Sr VP of Phase Forward’s Lincoln Technologies Group, he was formerly CIO at PAREXEL and has worked for BBN and TASC. He possesses over 20 years of IT experience, with a BA from the U of Illinois and an MBA from Boston U.