SDTM Work Stream Basel, September 2, 2008

CDISC User Group Work Streams Sharing of expertise and knowledge The SDTM Work Stream Profile Interest by newcomers Experience in succesful creation of SDTMs incl. submissions to FDA Experience in conversions of „dirty“ legacy data into SDTM One SDS team member from the global working group for Controlled Terminology Connection to TMF (Telematikplattform für Medizinische Forschungsnetze www.tmf-ev.de), eg. for SAS-Macros, ODM to SDTM Converter One member working on an internal „SDTM+“ implementation (BRIDG)

CDISC User Group Work Streams Identification of implementation issues Gaps in the standards and / or in the documentation -> There is a need for further development steps User-related Issues -> There is a need for more/improved training and communication Documents in global member area which are not complete and/or up-to-date Areas for experience exchange Sponsor-to-FDA communication Use of the SDTM beyond submissions „Metadata Repository“ (ongoing project at TMF) From SDTM to Define

CDISC User Group Work Streams New requirements The group strongly recommends a quick improvement of the CDISC downloadable documents: In addition to the very useful .pdf versions of the Implementation Guidelines, documents in XML are mandatory for the systematic use of standards (domain definitions, variable definitions, etc.) in Data Management systems and further development hereof.

CDISC User Group Work Streams Goals 2009 To explore the importance of the SDTM for companies To explore how the SDTM is used To make best use of the new CDISC user group internet portal To exchange experience regarding concrete issues To discuss obstacles, gaps and pitfalls To hold regular net meetings / phone conferences (approx. every 6 weeks) The European Interchange remains the forum for general presentations.