1. SDTM Work Stream
Basel, September 2, 2008

2. 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 eg. for SAS-Macros, ODM to SDTM Converter
One member working on an internal „SDTM+“ implementation (BRIDG)

3. 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

4. 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.

5. 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.